Our team is dedicated to supporting the clinical trials community as part of our BC AHSN COVID-19 response. This page highlights the COVID-19 response activities and available resources in BC, Canada and internationally – specifically for clinical researchers. As this webpage is updated regularly, we encourage you to bookmark this URL and continue to check this page, in addition to the BC AHSN page, for new content.
Clinical Trials BC Resources and Supports
A COVID-19 Clinical Trials Network for British Columbia:
As the clinical trial community in British Columbia mobilized in anticipation of COVID-19 trials, members expressed a strong need for a network to enable increased communications and learning to support their coordinated approach. Clinical Trials BC responded by hosting monthly meetings since the onset of the pandemic in March 2020, attended by an average of 70 attendees from across the province. Additionally, we have engaged our growing informal network of over 120 members through a variety of communications channels including by email, Slack and Twitter.
Monthly Meetings:
Virtual one-hour Zoom meetings are held in a consistent meeting format that includes a rapid round-table to hear from trial investigators on their current study status. This is followed by speakers on current opportunities and challenges related to trial start-up and conduct, and ending with presentations on available supports and resources for clinical researchers and their teams.
One of our participants provided the following feedback after the conclusion of a recent meeting:
"Excellent opportunity to connect with other sites to discuss obstacles, opportunities, and navigate this pandemic as a cohesive team rather than in silos.”
Another attendee stated that the meeting:
“…Provided a sense of ‘who was doing what’ [and] gave some insight into new processes.”
Join the Network:
Anyone conducting or supporting COVID-19 clinical trials in BC is welcome to attend. To join this informal network and receive meeting invites and communications, please sign up for our mailing list.
If you have content or updates you would like to share with the network or would like to speak at a future meeting, please contact Alison Orth.
Previous meeting agendas can be found below. If you wish to receive more information such as PowerPoint presentations from these meetings, please contact Alison Orth.
Join our SLACK Channel and Twitter
Join our Clinical Trials COVID-19 Network SLACK Channel and Twitter where our members can stay connected, share resources and news etc.
Resources:
- COVID-19 resources for Clinical Trials BC and BC AHSN
- Current COVID-19 Trials in BC
- BC AHSN’s Inventory Page for a searchable list of COVID-19-related research in BC
- Recruitment for Participants and Patient Partners in COVID-19 Clinical Trials via REACH BC Platform
General Information & Reimbursement
Clinical Trials BC (a unit of the BC Academic Health Science Network) supports clinical research professionals working at academic-based BC clinical research sites to achieve professional certification. Achieving certification demonstrates that you have met or exceeded the quality standards required in the industry and have validated your competence. Certification also demonstrates a level of professionalism and indicates a commitment to quality standards.
For 2021, Clinical Trials BC is offering a partial reimbursement in the amount of $350 towards CCRP or CCRC examination fees for successful applicants who work for academic health research organizations (health authority, university, non-profit).
Funding is available for up to 20 successful applicants.
Eligible Certifications
SOCRA
The Society of Clinical Research Associates (SoCRA) established the Certification Program for Clinical Research Professionals (CCRPs) to create an internationally accepted level of knowledge, education, and experience by which clinical research professionals will be recognized by the medical research community. SoCRA offers both paper and pencil exams and Computer Based Testing.
ACRP
The Association of Clinical Research Professionals offers two eligible certifications, CCRC and CCRP. The ACRP-CP® credential is awarded to professionals involved in all aspects of clinical studies/trials who have demonstrated the knowledge, skills, and abilities to perform ethical and responsible clinical research. CCRC® credential is awarded to a CRC (clinical research coordinator) who has met eligibility requirements, demonstrated proficiency of specific knowledge and job‐related skills. ACRP offers computer-based testing only.
Application Process
Applicants must register first with SoCRA or ACRP for the certification program, then to Clinical Trials BC for eligibility for reimbursement.
Applicants are required to apply to Alison Orth by email for approval of eligibility prior to writing their exam.
The package must include:
- A copy of the applicant’s application to SoCRA or ACRP
- A copy of the applicant’s CV/resume
- A letter to Clinical Trials BC that includes the following details:
- Why certification is important to them;
- How it will benefit them in their role as a clinical research professional;
- Their career aspirations;
Clinical Trials BC will review applications and notify successful candidates of their eligibility for reimbursement prior to their certification exam.
Exam Costs & Reimbursement Amount
Clinical Trials BC will reimburse up to 20 successful program applicants $350 CDN upon receiving confirmation of certification.
Please review the Application and Fee sections of each organization for costs.
ACRP:
Exam Preparation
To help you prepare, Clinical Trials BC has made available recordings of a series of consecutive informal exam preparation sessions that took place in 2020. The sessions will be available along with materials until Dec 31, 2021.
To further help your studies four open Q&A sessions will be available on Thursdays as follows (click the the link to register on Zoom):
Registration is available by following each session link above. To register for access to the recorded sessions or the hosted Q&A, please email us.
Testimonials
Here’s what two successful applicants had to say about their experience:
“The certification gave me an edge as well as better promotion opportunities. Clinical Trials BC added to my fulfillment by partially reimbursing my exam fee. I felt that my achievement was not just recognized but rewarded as well.” – Nera, Clinical Research Professional
“Among my peers and supervisors, certification has also brought recognition of the rigorous ethical and quality standards that I follow in my conduct of clinical research. This accomplishment would not have been as readily attainable…if it were not for the generous funding from Clinical Trials BC.” – Mannie Fan, Clinical Research Coordinator
Network of Networks (N2)
Clinical Trials BC provides province-wide access to best-in-class tools and resources from the Network of Networks (N2), focused on enhancing clinical research capability and capacity. N2 benefits are available for clinical researchers working in health authorities and academic organizations in BC, as well as for some independent investigators.
N2 is an alliance of Canadian research networks and organizations working to enhance national clinical research capability and capacity. N2’s vision is “To be recognized as Canada’s alliance for excellence in clinical research,” and its mission is “To enable and enhance clinical research capability and capacity in Canada.”
Tools and resources that are available through N2 membership include Educational courses (available via CITI-Canada), Standard Operating Procedures, Quality Tools, Tools to Engage Participants and more.
We’re a longstanding member of the N2 Clinical Trials Education and Awareness (CTEA) committee, which co-developed the It Starts With Me project and website in partnership with patients. This campaign encourages patients and public stakeholders to participate in clinical trials. Please see our Participant Experience page for more information.
This Clinical Trials BC initiative is made possible through a provincial membership agreement with BC AHSN, funded through the BC SUPPORT Unit’s Training & Capacity Development initiative.
For more information on N2, please see the below contacts:
Provincial BC Membership:
- Status of an organization
- N2 Lead for an organization
- Funding Status or Usage metrics
All other questions:
- CITI courses, access and use of resources, SOPS etc.
ACRP learning management system (LMS)
Thanks to a partnership between Clinical Trials BC and the Vancouver Coastal Health Research Institute (VCHRI), this e-learning platform offered by the Association of Clinical Research Professionals (ACRP) is available free of charge to any clinical research professional in BC.
ACRP’s eLearning catalog of 30+ programs covers the essentials of clinical research, including the new “Introduction to Good Clinical Practice” eLearning course, which provides training on the new ICH GCP E6(R2) as the international industry standard for designing, conducting, and reporting clinical trials.
Since our partnership began, more than 300 people have signed up for access to the ACRP LMS. We continue to encourage the BC research community to register and complete courses.
If you’re a new user, you can gain access by contacting us at Clinical Trials BC. Simply send a request along with your first and last name, email address and research location. Instructions on how to login and begin training will be provided within one week.
Other Resources
Clinical Research Professionals of BC (CRPBC) – CRPBC is an informal, inclusive group of more than 450 Clinical Research Professionals who work primarily in the Lower Mainland of British Columbia. They provide networking and professional development opportunities for everyone working in the clinical research profession. Visit this site for job listings, information about their speaker series, and more.
The COVID-19 crisis has created a need to rapidly expand clinical trial capacity in all regions of BC. The intent of this program is to condense the training time for trial personnel supporting site research teams while ensuring quality are absolutely essential to these efforts.”
– Cindy Trytten, Director of Research and Capacity Building, Island Health
Clinical Trials BC launched its new COVID-19 Rapid Response Training Program in April 2020. This program was developed for new researchers, new research team members and in particular, new supporting personnel that will be involved in COVID-19 clinical trials.
Jean Smart, Regulatory Affairs and Quality Officer has organized training modules and supporting materials on a Clinical Trials BC ECoP (Electronic Community of Practice) established for COVID-19 Rapid Training.
The modules include:
- Regulatory Introduction (Canadian regulatory environment, Historical Documents);
- Core ICH (E6 -Good Clinical Practice, E8- General Considerations in Clinical Trials, E17- Multi-Regional Clinical Trials);
- Research Teams (Roles and Responsibilities, Training and Qualifications);
- Records (Essential Documents, Good Documentation Practices); and
- Special Topics (safety, Investigational Product, Data).
These modules include access to supporting reference documents, condensed notes, recorded sessions, slides and self-quizzes). We will continue to add to the programme over the coming weeks and welcome any suggestions.
“[Research and Quality Managers] can preview and select the modules and units that fit the training requirements of the new site/study personnel. Appropriate training opportunities and the best head start will be provided, while we quickly prepare for COVID-19 trials.”
– Coleen Adderley, Manager of Clinical Research, Interior Health
- For registration and access to the COVID-19 Rapid Training ECoP, please contact us by email.
Clinical Trials BC offers regulatory and compliance consulting services for domestic and international trials within BC.
At this time priority is given to ongoing studies with concerns over participant safety and safety reporting. The following are also be considered priorities: maintenance of IP (security, environmental conditions, accounting), label changes, collection of the critical data elements/safety determinants, documentation of deviations from SOPs (planned and unplanned), updates of risk management plans and documentation of protocol deviations (i.e. excursions from visit schedules, in person versus virtual visits).
If you have a question or concern related to clinical trials regulation or compliance we are happy to respond and assist you to navigate to a resource or the appropriate contact person or other services. Please contact Jean Smart for questions, concerns and assistance.
In response to the COVID-19 pandemic, Clinical Trials BC is leading additional projects:
COVID-19 capacity added to the Clinical Trials Asset Map
We are updating the BC Research Capacity in the Canadian Clinical Trials Asset Map (CCTAM) and we need your help!
The asset map allows for effective collaboration among research sites and demonstrated capacity for clinical trials – in particular, COVID-19 capacity at this current time. Additionally, it serves as a tool enabling clinical trial sponsors to locate investigators, clinical research sites, hospitals, institutions, research ethics for the conduct of trials as well as enabling investigators to engage in investigator-initiated research.
What do we need from you?
- If you are a clinical research organization, site, agency, hospital, institution, investigator, ethics board, or university, and you are not in our asset map, please create your profile here.
- If you are already in our asset map, please login and review your profile to make sure it is up to date and demonstrate if you are able to support COVID-19 research.
Trial Linking Services
Clinical Trials BC links sponsors, investigators and sites with one another. Any COVID-19 studies are a current priority. Please contact Alison Orth if you require linking or navigation. We are setting up a COVID-19 specific Clinical Trial Listing for the province. For more information about clinical trial capacity in BC please visit our BC Showcase website which includes a directory of clinical trial investigators, sites and research institutions.
If you have any questions about these initiatives or require support, please contact Alison Orth.
Current Trials
- BC AHSN Covid-19 Research Inventory (filterable for clinical trials)
- REACH BC (Connects Volunteers to Research Trial & Studies)
- CovidTrials.ca (links Covid Researchers to Participants)
- Clinicaltrials.gov (Filtered for BC Trials)
- Health Canada List of Authorized Covid-19 Trials
Regulatory Updates and News
- The Canadian application process and alternate pathway for COVID-19 (Regulatory Focus, PDF) (added September 23, 2020)
- Race Against the Clock: COVID-19 Vaccine and Treatment R&D in Canada (Video)
- Applications for drug clinical trials under the Interim Order: Guidance document (posted May 27, 2020)
- Applications for medical device clinical trials under the Interim Order: Guidance document (posted May 27, 2020)
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (added April 29, 2020)
- EMA: Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic (PDF – added April 29, 2020)
- Health Canada: Management of Clinical Trials During COVID-19 Pandemic
- Government of Canada: Canada’s Plan to Mobilize Science to Fight COVID-19
COVID-19 Data Portal Update
Posted September 22, 2020
The COVID-19 Data Portal was launched in April 2020 to bring together relevant datasets for sharing and analysis to accelerate coronavirus research. It enables researchers to upload, access and analyse COVID-19 related reference data and specialist datasets as part of the wider European COVID-19 Data Platform.
Enquire on how to collaborate on the European COVID-19 platform
Share your data on COVID-19 Data Portal
COVID Vaccine News
Posted September 22, 2020
Countries representing nearly two thirds of the world’s population have now signed on to The World Health Organization’s COVID-19 vaccine development and manufacturing accelerator. In all, 64 higher income countries have joined the COVAX facility, with an additional 38 expected to join in the next two months. Not participating in the worldwide effort are: The United States, Russia, and China.
A WHO World Health Organization (WHO) press conference was held on 21 September 2020 It that provided updates on global participation in COVAX and announced a global vaccine allocation framework. The initiative aims to have 2 billion doses of vaccine available for global distribution by the end of 2021.
The COVAX initiative is led by the World Health Organization (WHO), Gavi – the Vaccine Alliance — and the Coalition for Epidemic Preparedness Initiatives (CEPI). COVAX’s aim is “to guarantee fair and equitable access for every country in the world,” according to the WHO COVAX.
EU Implications of COVID-19 – Methodological Aspects of Ongoing Clinical Trials
Please see the revised document here.
EU Guidance on remote GCP inspections during the COVID-19 pandemic
June 10, 2020
The European Medicines Agency (EMA) posted a newly adopted guidance on June 10, 2020 explaining how remote good clinical practice (GCP) inspections will be conducted during the coronavirus disease (COVID-19) pandemic. It will be interesting to see if other health authorities follow suit in the near future. Many international health authorities have been conducting remote GMP inspections and have indicated plans for remote or hybrid GCP inspections.
More info is listed in our EMA Section.
Inspection Updates – Domestic and International Inspections and Meetings:
Week of March 16, 2020
Most domestic and international inspections have been temporarily postponed (Canada, Europe, Japan and US). Notices have been sent out by email to affected sites, investigators, facilities and sponsors booked for an inspection.
Posted March 19, 2020
Most, if not all, in person pre-submission and pre-trial meetings have been confirmed as postponed domestically and internationally. Priority meetings and safety meetings will be scheduled virtually.
ICH:
Posted July 20
MedDRA update for COVID-19
The Medical Dictionary for Regulatory Activities (MedDRA) is a rich, very specific, standardized medical dictionary developed by the International Council for Harmonisation (ICH). Health Canada is a member of the MedDRA management committee and a standing member of ICH.
A large number of terms specific to COVID-19 are being added to the MedDRA database. Common definitions are used to ensure consistency in activities like adverse event reporting. This helps industry and regulators more effectively monitor the safety of drugs throughout their lifecycle, from clinical trials to post-market surveillance.
Posted April 1, 2020
New MedDRA for COVID-19
The International Council for Harmonisation (ICH) on Wednesday announced that the Medical Dictionary for Regulatory Activities (MedDRA) is being updated with new supplemental terms and corresponding codes related to coronavirus disease (COVID-19).
“The coronavirus pandemic has prompted an urgent need for a harmonised, standardised approach to coding and reporting the infection as a global health issue,” ICH says, noting that more terms are in the process of being reviewed.
The new supplemental terms are already available via the MedDRA Maintenance and Support Services Organization’s (MSSO) web-based browser, but will not become official until the release of MedDRA Version 23.1 in September. They are also posted on the ICH website under MedDRA.
The proposed supplemental terms aim to be more specific than existing terms related to COVID-19. For instance, an existing term “LLT viral test” will be replaced with a supplemental term for “PT SARS-CoV-2 test.”
ICH says it will continue to provide updates as the new terms are added.
- Download the ICH M1 Points to Consider Working Group and MedDRA MSSO Communication on Coronavirus (PDF)
Health Canada:
Posted October 02
There are six links below to our most frequently requested Health Canada COVID and general clinical trial related documents in the past 8 weeks. Most notable is the order of August 14th 2020 which extended the default period by 15 days for clinical trial review from 30 days to 45 days. You cannot start your clinical trial after 30 days. This order does not change the expedited review process for COVID-19 applications.
- Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 [2020-09-17]
- Interim order and guidance document to import, sell and advertise COVID-19 related drugs and vaccines: Notice [2020-09-17]
- Drug and vaccine authorizations for COVID-19 [2020-09-17]
- Order to extend review period for clinical trial applications and amendments: Notice [2020-08-14]
- Good Manufacturing Practices and COVID-19 [2020-08-07]
- Drug establishment licences and COVID-19 [2020-08-07]
Posted September 22
There are three new HC regulatory documents related to COVID-19 that are well worth the read. Import exemptions for Clinical Trials are still in effect for investigational products Phase 1 to Phase IV. If there is any ensuing confusion, please do contact us at Clinical Trials BC.
Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the Interim Order) to respond to the urgent need for COVID-19 diagnosis, treatment, mitigation or prevention options. The Interim Order introduces a new pathway with regulatory mechanisms to expedite the authorization for importing, selling, and advertising of COVID-19 drugs during a public health emergency without compromising patient safety.
A Notice and a Guidance Document have also been published to accompany the Interim Order.
There is also an accompanying frequently asked questions document.
Posted July 10, 2020 Update Report
Health Canada has published a Report which is a mid year update on the drugs and medical devices approved in 2020. Many of these are related to COVID-19.
Posted July 3 Health Canada General Regulatory Update for COVID-19
Health Canada Guidance HC regulatory response to Covid-19 Access to health products
One of Health Canada’s roles is to regulate and authorize health products that improve and maintain the health and well-being of Canadians. The COVID-19 pandemic has created an unprecedented demand on Canada’s health care system and has led to an urgent need for access to health products. Health Canada has update its regulatory response page for COVID-19.
Posted May 27, 2020 - Applications for drug clinical trials under the Interim Order: Guidance document
Health Canada has developed this guidance document specific to support the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 (Interim Order) pursuant to subsection 30.1(1) of the Food and Drugs Act. The document provides guidance to applicants for seeking authorization of and conducting COVID-19 drug clinical trials under the new Interim Order. It is detailed and is a must read
Posted May 27, 2020 - Applications for medical device clinical trials under the Interim Order: Guidance document
Health Canada has created a guidance document that is intended to support applicants who wish to sell or import a COVID-19 medical device for the purposes of a clinical trial (also known as investigational testing), or to conduct a clinical trial in respect of a COVID-19 medical device, as authorized under the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 (“Interim Order”). Read the updated document.
Posted April 23, 2020 - Vaccines and Treatments for COVID-19
Health Canada has created and posted a database or listing of all authorized Clinical Trials approved by Health Canada. This listing is updated weekly. At present date there are 18 entries. This is a separate listing from the Health Canada Clinical Trials Database.
Posted April 23, 2020 - Facilitating Clinical Trials
Health Canada has reissued a notice for Companies and researchers with drugs, medical devices, or natural health products that may be effective in treating or diagnosing COVID-19 are encouraged to contact us to facilitate clinical trials.
Clinical trials are studies to find out whether a drug or medical device is safe and effective for people. We can authorize a clinical trial quickly in urgent situations. Please contact us at:
- trials using pharmaceutical drugs
- trials using biologics or radiopharmaceuticals
- trials using natural health products
- investigational testing of medical devices
Reposted April 24, 2020 (reminder as requested) - Management of Clinical Trials during the COVID pandemic
Health Canada issued A Notice to Clinical Trial Sponsors on the impact of the pandemic on the conduct of clinical trials, including the need for: participants to self-isolate deployment of healthcare personnel involved in clinical trials to other duties during this public health emergency. There is important site information contained in this notice. We have reposted this notice for site review.
Posted March 24, 2020 - Health Canada Guidance on Management of Clinical Trials during the COVID-19 Pandemic
Health Canada has released a Notice ‘Management of Clinical trials during the COVID-19 pandemic: Notice to sponsor. This two-page document shows the pragmatic response of Health Canada on key impacted areas. Health Canada makes concise suggestions on actions to mitigate compliance items that may need adjustment. This is a must read article for sponsors and investigative research teams alike.
Posted March 20, 2020 - Health Canada Notice regarding Medical Devices and COVID-19
On March 18, 2020, the Minister of Health approved an Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. The order file number for reference is 20-104980-839 The interim order will enable an expedited review of medical devices indicated to diagnose, treat, mitigate or prevent COVID-19, at no cost.
COVID-19 is a new disease not previously identified in humans. Currently there is no vaccine or therapeutic product for COVID-19 that is authorized to treat or prevent the disease. The outbreak of COVID-19 has resulted in a global review of therapies that could be used to treat or prevent the infection.
Sponsors wishing to file a submission or application should contact the appropriate review bureau.
Review Bureau Contact Information:
Biologic and Radiopharmaceutical Drugs Directorate Office of Regulatory Affairs
Tel: 613-957-1722
Fax: 613-946-9520
EmailTherapeutic Products Directorate:
Bureau of Gastroenterology, Infection and Viral Diseases
Telephone: 613-941-2566
Fax: 613-941-1183
EmailSubmission Management Division, Office of Clinical Trials
Fax: 613-946-7996
EmailSpecial Access Programme – drugs
Telephone: 613-941-2108
Fax: 613-941-3194
E-mailNatural and Non-prescription Health Products Directorate (NNHPD)
Regulatory Project Management Unit, servicing Non-prescription Drug Evaluation Division
Fax: 613-946-9614
Telephone: 613-946-9315
Telephone: 613-957-6801 for the Regulatory Project Management Unit
EmailMedical Device Directorate:
Bureau of Device Licensing Services
EmailInvestigational Testing
Telephone: 613-941-4308
E-mailSpecial Access Program – Medical Devices
Tel: 613-946-8711
Fax: 613-957-1596
EmailUS Food and Drug Administration:
Posted July 18 - Coronavirus (COVID-19)Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing
The U.S. Food and Drug Administration reissued an emergency use authorization (EUA) to Quest Diagnostics to authorize a test for use with pooled samples containing up to four individual swab specimens collected under observation. The ‘’Quest test’ is the first COVID-19 diagnostic test to be authorized for use with pooled samples.
Sample pooling is an important public health tool because it allows for more people to be tested quickly using fewer testing resources. Sample pooling does this by allowing multiple people – in this case four individuals – to be tested at once. The samples collected from these four individuals are then tested in a pool or “batch” using one test, rather than running each individual sample on its own test. If the pool is positive, it means that one or more of the individuals tested in that pool may be infected, so each of the samples in that pool are tested again individually. Because the samples are pooled, it is expected that fewer tests are run overall, meaning fewer testing supplies are used and more tests can be run at the same time allowing patients to receive their results more quickly in most cases. This testing strategy is most efficient in areas with low prevalence, meaning most results are expected to be negative.
Guidance on the use of non-invasive remote monitoring devices for patient care during the Coronavirus public health emergency was expanded and updated by the US FDA.
Posted July 21, 2020
The US Food and Drug Administration (FDA) has updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic again to clarify how sponsors can obtain informed consent from patients in isolation or who can receive electronic copies of informed consent documents but due to time constraints cannot print or electronically sign the documents. This document has been update frequently. Two methods are recommended.
Posted June 8, 2020
This guidance was originally published in March 2020. It permits in and outpatient management and use of monitoring devices to.
The use of non-invasive patient monitoring technology will help eliminate unnecessary patient contact and ease the burden on hospitals, other health care facilities, and health care professionals. The updated document now includes: both diagnostic and monitoring spirometers and peak-flow meters, apnea monitors, telephone ECG transmitting and receiving equipment, Electroencephalographs (EEGs) and non-EEG seizure monitoring systems, biofeedback and sleep assessment devices, audiometers, vestibular analysis apparatuses, and computerized cognitive assessment aids.All of the devices are Class II medical devices.
In the first edition only thermometers; ECGs, cardiac monitors, and ECG software; pulse oximetry and non-invasive blood pressure devices; and electronic stethoscopes and respiratory rate/breathing frequency monitors were acceptable.
The devices that are noted in this guidance may be connected to wireless networks through Bluetooth, cellular access or WiFi.
Posted May 14, 2020 - Clinical Trial Guidance Update
The US Food and Drug Administration (FDA) has updated its guidance on conducting clinical trials on May 13, 2020. This fourth edition for the coronavirus disease (COVID-19) pandemic addresses new questions, including:
- the use of alternate laboratory or imaging centers,
- video conferencing and
- post-marketing requirements.
The update also features clarifications to questions addressed in previous versions of the guidance on managing protocol deviations and amendments and on steps sponsors should take when considering administering investigational products at home instead of at clinical trial sites. While this guidance comes from the US, it offers great practical advice to others in the same global region.
Posted week of May 11, 2020 - New Guidance Document
The US Food and Drug Administration released a new Guidance this week titled ‘COVID-19: Developing Drugs and Biological Products for Treatment or Prevention. This Guidance for Industry, has been developed quickly in response to COVID-19 pandemic, without public or stakeholder review. It is intended to assist sponsors in the clinical development of drugs for the treatment or prevention of COVID-19. This guidance does not apply to vaccines.
Posted April 2020 - Updated FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards
In April, the US Food and Drug Administration (FDA), added seven new questions and answers to its guidance document on the conduct of Clinical Trials during the COVID-19 pandemic. These include guidance on obtaining informed consent during the pandemic; considerations for remote clinical outcome assessments; remote site monitoring; electronic common technical document (eCTD) waivers; and other issues. Similar to the EU Commissions guidance document for conduct of clinical trials during the pandemic, this one also provides some practical suggestions.
Posted April 17, 2020 - New regulatory information on AE reporting during COVID-19 pandemic
The US Food and Drug Administration revised its guidance on post-market adverse event reporting for medicinal products and dietary supplements during a pandemic to apply the guidance to the ongoing coronavirus disease pandemic.
Posted April 2, 2020
The US Food and Drug Administration (FDA) updated its guidance from from earlier in March on conducting clinical trials during the coronavirus disease (COVID-19) pandemic.
The new version, features a new appendix with ten questions and answers offering more specifics on how sponsors should manage clinical trials amid the pandemic based on questions the agency has received from sponsors so far. The remainder of the guidance is unchanged from the previous version.
Posted March 20, 2020
On March 19, 2020 The US Food and Drug Administration (FDA) revised its guidance on post-market adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing coronavirus disease (COVID-19) pandemic.
The guidance, applies to drugs, biologics, medical devices, combination products and supplements, outlines how the US FDA intends to prioritize adverse event reporting requirements during a pandemic.Note for Clinical Trials BC: There has been some ‘local confusion’ about this guidance. Please note for clarification purposes:
- This guidance does not apply to clinical trials.
- The revised guidance does apply to all pandemics, including COVID-19.
Posted March 18, 2020
The US FDA issued a new final guidance to help clinical trial sponsors assure the safety of trial participants, maintain compliance with good Clinical practice (GCP) and minimize the risks to trial integrity during the COVID-19 pandemic. This guidance is good reference for practice as related to trials conducted during the pandemic, and not necessarily for trials related to COVID-19 treatments.
Read the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic posted on March 18, 2020.
Innovative Medicines Canada:
Posted March 23, 2020
Innovative Medicines Canada (IMC) issued a statement in response to the federal government’s announcement of measures to aid in the rapid mobilization of large-scale efforts by Canadian researchers and life sciences companies working to combat COVID-19, including through the development of solutions to diagnose, treat and prevent the virus.
Posted March 19, 2020
IMC’s statement on Canada’s drug supply in response to this crisis. The IMC’s statement notes that there are no COVID-19 related shortages being reported, or current constraints on our member’s ability to supply innovative medicines to Canadians. IMC’s full statement on drug supply can be viewed here – IMC’s statement on Canada’s drug supply.
EMA:
European Commission Guidance
Posted July 21: EMA infrastructure for Covid-19 Real-World monitoring of treatments and vaccines
The EMA has set up an infrastructure to support the monitoring of the efficacy and safety of Covid-19 treatments and vaccines when used in day to day practice. This is supported by academic and private partners with the EMA.
Posted April 28, 2020
The European Commission and European Medicines Agency (EMA) updated their guidance on managing clinical trials during the coronavirus disease (COVID-19) pandemic, adding advice on distribution, data verification and communicating with authorities.
This is the third update of the guidance from the Commission, EMA and the Heads of Medicines Agencies which was previously updated on 27 March 2020. This version provides recommendations on the distribution of investigational medicinal products (IMPs) and data verification under social distancing measures and resource limitations. The guidance also clarifies how clinical trial sponsors should communicate urgent issues to regulatory authorities.
While this guidance specific to Europe, it offers some good general advice applicable to other jurisdictions and is a recommended read. It provides recommendations on effective mitigation related to the disruptions associated with the pandemic, to ensure that quality and safety are not compromised during the adapted conduct of clinical trials.
Posted April 20, 2020 - Update of the EMA Q&A guideline on COVID-19 regulatory expectations – medicinal products
The European Medicines Agency (EMA) updated its recent question and answer guideline on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic.
Posted March 27, 2020 - EMA Releases a Second Guideline Clinical Trials Methodological Aspects during a COVIC-19 pandemic
The EMA has acknowledged the impact of the Coronavirus disease (COVID-19) on trial participants and now as well as of the resulting measures taken to address the pandemic on methodological aspects of ongoing trials. This new three page guidance provides guidance on the collection, analysis and the interpretation of clinical trial data and safety. Sponsors are strongly recommended to integrate all available knowledge from the ethical, the medical, and the methodological perspective into decision making about the future conduct of a trial while carefully considering advice from regulatory and healthcare authorities responsible for patient and employee safety. Reference is made to other guidance related to the COVID-19 pandemic, including (Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic (EMA/141885/2020).
Posted March 22, 2020 - New EMA Guidance Document of Management of Clinical Trials during the COVID-19 Pandemic
The European Commission, European Medicines Agency (EMA) and the Head of Medicines Agencies released guidance for biopharma companies that may need to adjust their clinical trials during the COVID-19 pandemic. This 8-page guidance is similar to the one issued by the US FDA.
It contains specific advice on measures that sponsors may want to consider, including the conversion of physical patient visits into phone or video visits, a temporary halt of a trial at some or all trial sites, the suspension or slowing down of recruitment of new trial participants, the extension of the duration of the trial, and/or the postponement of trials or activation of sites that have not yet been initiated.
The guidance also covers the COVID-19 challenges of: clinical trial monitoring, protocol deviations and administering informed consent to participants in COVID-19 trials. It properly references The International Harmonization Council (ICH) E6R2 Good Clinical Practices and ICH E3 Clinical Study Report requirements.
EMA, in releasing this document, notes that there may be updates the guidance.
- Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemi
- EMA on COVID-19 (online page)
Posted March 20, 2020
This week global health authorities and the World Health Organization (WHO) held a workshop on facilitating global collaboration on vaccine development for COVID-19.
In response, The European Medicines Agency (EMA) on March 19, 2020 called on EU-based researchers to pool their resources to conduct large, multi-center, multi-arm clinical trials for potential treatments for coronavirus disease (COVID-19).
These types of studies are identified as the most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments but small studies and compassionate use programs may also generate robust enough data to draw conclusions from. Specifically, EMA’s Committee for Medicinal Products for Human Use (CHMP) says randomized controlled studies featuring a control arm without antivirals or other experimental therapies would provide the most reliable evidence in support of an investigational product.
The call for a coordinated approach comes as companies and researchers around the globe scramble to develop treatments and vaccines for the virus. While the virus originated in China, Europe has become the epicenter of the pandemic, with major outbreaks in Italy, Spain, France and Germany, with the death toll in Italy surpassing China’s as of March 20, 2020.
European regulatory agencies are giving priority to all requests regarding regulatory aspects in clinical trials” for products intended for COVID-19.
Research Ethics BC (REBC):
Posted March 18, 2020
Research Ethics BC has issued recommendations regarding COVID-19.
The Society for Clinical Data Management (SCDM):
Posted March 27, 2020
The SCDM has issued a statement which outlines the risk categories related to methodology and their impact on the practices of clinical data collection and management due to COVID-19. They are also encouraging Senior Data Managers to be involved in the development of mitigation strategies in site and sponsor level risk management.
MHRA (UK):
Posted July 13 - Guidance for patients, the public and professional users guide to COVID-19 tests and testing kits
The MHRA issued a new very practical and well laid out guide for COVID-19 tests and testing kits.
Posted April 1, 2020 - COVID-19 Risk Assessments Required
The MHRA announced it has written to all sponsors conducting Phase I clinical trials to confirm they have conducted a risk assessment for the potential impact of COVID-19 on their studies.
“This action will help to ensure the safety of participants and the public, as well as avoid any adverse impacts on the capacity of [National Health Service] NHS front line services at this very challenging time.” MHRA says it expects that some trials “may be temporarily halted or terminated,” while others may continue if “clearly justified.”
Note: Clinical Trials BC would like to clarify that that the action outlined by the MHRA does not apply to studies for potential treatments for COVID-19 for this health authority. However, update of risk management plans is a trend and expectation in other jurisdictions at the institutional and site levels as well as sponsor level.
The International COVID-19 Trackers for Vaccines and Therapeutics:
Posted October 2, 2020
This tracker lists COVID-19 vaccine candidates currently in Phase 1-3 trials, as well as major candidates in pre-clinical stages of development and research. A new feature of the tracker includes a ‘Details’ button which reveals in-depth information about each candidate.
Updates in this version include new entries from: Shenzhen Kangtai Biological Products, Vector Institute and COVAXX, as well as updated information on vaccine candidates from Moderna, Johnson & Johnson, Novavax, CureVax, Pfizer/BioNTech, Oxford/AstraZeneca and Inovio.We thank the RAPS focus team and Jeff Craven for continuing their work on this and the therapeutics tracker.
The International COVID-19 Trackers Vaccine and Therapeutics Trackers are now separated and are now being managed by Jeff Craven and team at the Regulatory Affairs Professional Society (RAPs).
Posted September 17, 2020 - International Vaccine Tracker – Excerpt by Jeff Craven, RAPs
Jeff Craven and team at RAPs have once again presented a list of the COVID-19 vaccine candidates currently in Phase 1-3 trials, as well as major candidates in pre-clinical stages of development and research. The list reveals in-depth information about each candidate. As well he provides a good summary of the:
- Sputnik V development by the Gamalaya Research Institute in Moscow
- Operation WarpSpeed (OWS) in the US
- COVAX and initiative of the WHO which is part of the WHO Access to COVID tools (ACT) Accelerator.
Posted August 6, 2020
The International tracker lists COVID-19 vaccine candidates that are registered and currently in Phase 1-3 trials, as well as major candidates in pre-clinical stages of development and research. This edition includes new information on vaccine candidates from University of Melbourne and Murdoch Children’s Research Institute/Radboud University Medical Center/Faustman Lab at Massachusetts General Hospital, Moderna, Johnson & Johnson, Merck, ImmunityBio, and Bharat Biotech/National Institute of Virology. We gratefully acknowledge the work that the RAPs Focus team has done on collating this information for the global regulatory authorities and community.
Meanwhile, International regulatory agencies and the WHO are working to secure a supply of vaccine for their regulatory jurisdictions. In Canada, the Federal Government announced on August 5, 2020 deals with two international companies for COVID-19 vaccines. The details of the agreements reached with Moderna and Pfizer have not been posted. It is understood that the supplies will be available for 2021 if all proceeds well in Phase III trials and the approval process.
Read more from The Globe and Mail
Posted July 23, 2020
The International vaccine tracker was updated and posted on July 23, 2020.
Posted July 16, 2020 by RAPS with International contributions
In this edition there is new information on vaccine candidates from: Chulalongkorn University, Zydus Cadila, Moderna, Pfizer and BioNTech, AstraZeneca and IQVIA, Anhui Zhifei Longcom Biopharmaceutical, Imperial College London, Medicago, Altimmune, University of Queensland,and Bharat Biotech. There are now 41 entries in the tracker which includes vaccines in Phase 1-3 trials and the pre-clinical categories.
Posted June 25 2020
It is interesting watching the progress made over the last three months. This tracker now lists COVID-19 vaccine candidates currently in Phase 1-3 trials, as well as major candidates in pre-clinical stages of development and research. The tracker has new information on vaccine candidates from Genexine, Gamaleya Research Institute, Anhui Zhifei Longcom Biopharmaceutical/Chinese Academy of Sciences, Sanofi/Translate Bio, GlaxoSmithKline/Clover and AstraZeneca/University of Oxford.
Posted June 11, 2020
This tracker lists COVID-19 vaccine candidates currently in Phase 1-3 trials, as well as major candidates in pre-clinical stages of development and research. The tracker now include new information on vaccine candidates from Moderna, University of Oxford/AstraZeneca, Sinopharm/Wuhan Institute of Biological Products, Sinopharm/Beijing Instittue of Biological Products, Novavax, Imperial College London, Johnson & Johnson, Altimmune, CSL/University of Queensland and Massachusetts Eye and Ear/Massachusetts General Hospital/University of Pennsylvania.
Posted October 2, 2020 - International Therapeutics Tracker – Excerpt from Jeff Craven, RAPs
This tracker lists COVID-19 vaccine candidates currently in Phase 1-3 trials, as well as major candidates in pre-clinical stages of development and research. A new feature of the tracker includes a ‘Details’ button which reveals in-depth information about each candidate.
Updates in this version include new entries from: Shenzhen Kangtai Biological Products, Vector Institute and COVAXX, as well as updated information on vaccine candidates from Moderna, Johnson & Johnson, Novavax, CureVax, Pfizer/BioNTech, Oxford/AstraZeneca and Inovio.We thank the RAPS focus team and Jeff Craven for continuing their work on this and the therapeutics tracker.
Posted September 18, 2020
This version includes new entries for PF-00835321 and updated information on COVI-GUARD, Veklury, Bucillamine, LY-CoV555 and REGN-COV2 and all other therapeutics in the regulatory listings.
Posted July 31, 2020
This version of the therapeutics tracker includes new information on dexamethasone, RLF-100, Actemra, lenzilumab, convalescent plasma, Pepcid, TXA127, LAM-002A and DNL758. We again thank the RAPs Focus team for maintaining this rapidly changing information tracker which is used as source for the global regulatory authorities and regulatory community.
Evidence of progressing therapeutics was seen last week here in Canada when Health Canada (HC) granted conditional approval NOC(c) to Gilead Sciences Inc’s antiviral treatment Remdesivir to treat patients with severe symptoms of COVID-19. This is the first approved treatment for the fast-spreading illness in Canada. Remdesivir has become the treatment of choice for many countries against severely ill COVID-19 patients after the intravenously-administered medicine helped shorten hospital recovery times in a clinical trial. The drug, Remdesivir, has been granted emergency or conditional authorization in several countries including from the ACSS Coalition: Singapore and Australia along with Canada. Japan and the USA have also approved it.
Posted July 17, 2020 by RAPS with international contributions
We all thank RAPS for their continued COVID-19 support in collating the information on behalf of the international regulatory community. The treatment candidates that lower mortality rates and lessen the severity of COVID-19 are under investigation worldwide. In this update we see new information on: Veklury, dexamethasone, Avigan, RLF-100, INOpulse, JS016, and Actemra (tocilizumab). There are now 31 entries in this tracker.
Posted June 26, 2020 RAPS
The world is looking at treatments that could lower mortality rates and decrease the severity of COVID-19. Only three therapeutics have to date been approved to treat COVID-19.
Avigan (Italy, China and Russia),
Dexamethasone (UK).
Veklury (aka remedesivir) in Japan
There are several potential therapies in several large international trials.
Updated June 5 2020
Two therapeutics are approved to treat COVID-19:
Avigan (favilavir) in three countries – Italy, Russia and China
Veklury (remdesivir) in Japan
Potential therapies are being examined in several large international trials. The largest, SOLIDARITY, is sponsored by the World Health Organization (WHO). This Global initiative is evaluating the high-profile treatment candidates for COVID-19. One of the arms evaluating Hydroxychloroquine/chloroquine, was paused temporarily and resumed last week with modification on June 3, 2020.
Many agencies and sponsors also are investigating other therapeutic products for possible repurpose. In particular they are looking at products that have worked against similar coronaviruses, or are hypothesized to address SARS-CoV-2 based on the mechanism of action.
Update from May 28, 2020
The International Vaccine Tracker was updated this week to include new information on vaccine candidates from Merck, Moderna, CanSino Biologics and ImmunityBio. Again, thank you to Jeff Craven and the RAPs team for their efforts to update this tracker this week.
Update from May 27th, 2020
This edition includes new information on remdesivir, hydroxychloroquine and EIDD-2081. Thank you to RAPs Focus team for updating and maintaining this for the international regulatory community.
Update from May 14, 2020
The International COVID-19 Vaccine Tracker has been redesigned and classes Vaccines into: early development, pre-clinical, Phase I, Phase II and Phase II/III. The Tracker now includes content on Company or Organization, candidate name or number, investigational product details, status and newly added is the clinical trials registry notation which is a very convenient addition.
Update from May 8, 2020
The International COVID-19 Therapeutics Tracker has also been redesigned and classes COVID-19 therapeutics into two categories: Frontline Therapeutics and Novel Therapeutics. The tracker features content on: Name or Number, Class, Developer, Rationale, Regulatory action, Trials, Outcome and Status.
Both Trackers include international content from all Regions. Clinical Trials BC will post the trackers weekly. New content is being noted at the top of the tracker as it is updated. Any group or company with an update or content to add to the tracker can now do so by sending a note to Focus magazine to the attention Jeff Craven at the following email address: news@raps.org
A special Thank You to the RAPS Focus COVID-19 team for doing such a fabulous job at setting up and maintaining these two worldwide trackers on the FOCUS page and making this available to the research community during the COVID-19 pandemic.
Research Canada:
Race Against the Clock: COVID-19 Vaccine and Treatment R&D in Canada
Research Canada
Posted: May 22, 2020
Research Canada hosted a COVID-19 webinar in the end of May. This is the first in a planned series of Research Canada’s Virtual Expert Panels, A Race Against the Clock: COVID-19 Vaccine and Treatment R&D in Canada, features four of Canada’s top health researchers who are working to understand and treat this disease, and who are contributing to the global effort to ultimately defeat COVID-19. It is well done and runs 1hr 30 min including the Q&A session. There are two BC speakers on the agenda.
ICMRA:
Posted August 6, 2020 - Covid-19 Vaccine Development
Medicines regulatory authorities from around the world have published a summary report on August 6, 2020 highlighting the outcomes of the second workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).
ICMRA meeting: COVID-19 Real-World Evidence and Observational studies meets Regulation
Building International Cohorts
The ICMRA posted on August 6, 2020 a summary of the July 22, 2020 meeting on Covid-19 Real World Evidence and Observational studies meeting. There are three work streams led by the regulatory authorities and regulatory experts in this working group:
- Vaccine surveillance and vigilance (Lead: MHRA),
- Collaboration on pregnancy studies (Lead: MA),
- Building international cohorts (Lead: Health Canada)
Canada is the lead for the International Cohorts working group. Gayatri Jayaraman of Health Canada (HC), announced that the COVID-19 international cohorts working group had an initial meeting on 9 July 2020. Membership in this working group includes representation from EMA (Europe), FDA (USA), AEMPS (Spain) and Health Canada (Canada). The WG agreed on a set of criteria which will ‘enable the prioritisation of key regulatory/public health research question(s) for international collaboration, including the need for a large sample size, important rather than urgent research topics, regional comparisons, development of novel methodologies or infrastructure, overall impacts on public health and need for sub-cohorts’.
From the summary, it is anticipated that regulatory authorities and their stakeholder representative councils internally review and prioritises research questions/sub-questions for international collaboration based on the agreed upon criteria. The key questions were submitted and finalised on 29 July 2020. Common methodologies/approaches to optimise the use of observational data to address these questions in relation to regulation were discussed.
Global regulatory – COVID-19 therapeutics agreement on acceptable endpoints for clinical trials
International regulators have published a report on August 6, 2020 on the acceptability of various primary endpoints in the clinical trials conducted for the development of treatments for COVID-19 as agreed upon at the second workshop.
Many developers of medicines for the treatment of COVID-19 have regulatory process of conducting clinical trials or have approached their regulatory authorities with proposals for phase 3 clinical trials.
An agreement by regulators on acceptable endpoints will facilitate rapid and consistent implementation of future clinical trials for COVID-19 medicines across the world. There were two endpoint discussion areas: hospitalized patients with moderate to severe COVID-19 and outpatients with mild COVID-19.
Published July 17, 2020
A new international report provides a roadmap for Phase 3 clinical trials for developers of candidate vaccines for the novel coronavirus SARS-CoV-2. The report indicates which clinical and preclinical data will indicate a vaccine is ready for Phase 3 trials; it also lays out key considerations in designing Phase 3 clinical trials of vaccines for COVID-19.
The report reflects consensus reached at a 22 June 2020 teleconference under the auspices of the International Coalition of Medicines Regulatory Authorities and Councils. At the workshop, 100 representatives from 28 countries, regulatory councils and 20 of 57 regulatory authorities worked together to “harmonize regulatory requirements and streamline the development of COVID-19 vaccines.”
HC Canada was a participant as were two representatives from the Regulatory Canada Council.
EMBL-EBI International COVID-19 Research Portal
Posted week of July 21
EMBL’s European Bioinformatics Institute (EMBL-EBI) and partners today launched the COVID-19 Data Portal, which enables the sharing and analysis of data related to the new coronavirus, SARS-CoV-2. The initiative aims now to facilitate international collaboration to accelerate scientific discovery, monitor the pandemic and help develop treatments and a vaccine for the new coronavirus.
World Health Organization (WHO)
Posted July 21
Canada is one of the countries participating in the World Health Organization’s (WHO) research and development (R&D) blueprint vaccines plan to develop a COVID-19 vaccine. Canada’s contributions include helping to develop the blueprint, a global strategy and preparedness plan. This is intended to help countries quickly undertake R&D activities during epidemics. Canada is also participating in the WHO’s blueprint vaccines subgroup to keep up to date with COVID-19 vaccine technologies.
The WHO is conducting the well know Solidarity trial, an international clinical trial of candidate vaccines against COVID-19.
Pan American Health Organization (PAHO)
Posted July 21, 2020
The Pan American Health Organization (PAHO) is an international health agency for the Americas. It specializes in engaging in technical cooperation with member countries to:
- fight communicable and non-communicable diseases and their causes
- strengthen health systems
- respond to emergencies and disasters
PAHO’s national regulatory pandemic response framework helps to guide the PAHO region during a pandemic. Health Canada is a member of its COVID-19 task group, which consists of representatives from each national regulatory authority in the PAHO region.
Other Resources and Guidance
Informed Consent Guidance (Partnering with REBC)
BC AHSN Covid-19 Research Response Page
Listing of Funding Opportunities for BC Researchers
News and Articles
Race Against the Clock: Covid-19 Vaccine and Treatment R&D in Canada
The Search for a Covid-19 Treatment: A Tyee Video (tyee.ca)
5 Logistics Challenges That Could Delay a Covid-19 Vaccine (Barl)
Best Practices During Covid-19: Answers to Your Trial Questions from WCG Experts (Centrewatch)
Clinical Trials Feel Coronavirus Crunch (Applied Clinical Trials)
UK Health Officials Offer Coronavirus-Related Management Advice for Clinical Trial Conduct (ACRP)
Coronavirus Puts Spotlight on Virtual Trails (ACRP)
Changes to Research Made in Response to Covid-19 (WCG Clinical)