Question: "What information should be included in a trial protocol or completed trial article when the study had to undergo important modifications in response to extenuating circumstances such as COVID-19?"
"Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete".
Using a consensus process, a rapid review, and a survey of international trials community, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) Statement was developed by an international team of scientists, patient representatives, trial investigators, methodologists, ethicists, statisticians, funders, regulators, and journal editors. CONSERVE can guide on how to report on trials and trials protocols that face important modifications in extenuating circumstances like the COVID-19 pandemic.
Dr. Aaron Orkin from University of Toronto, who is one of the co-leads of the CONSERVE guidelines will be speaking about the development and intended use of these guidelines at ASK US Series Webinar on December 2, 2021.
Dr. Aaron Orkin is an emergency, family, and public health and preventive medicine physician, and a scientist with Unity Health Toronto and the Department of Family and Community Medicine at the University of Toronto. In 2019, he realized that he was among many trialists whose studies had been derailed by the COVID-19 pandemic. With a global team of trial experts, he developed CONSERVE to help make sense of the situation and improve the rigour of reporting trials affected by COVID-19 and other extenuating circumstances.
Everyone is welcomed to attend. Please submit any questions about the presented topic to us in advance. Your questions will be considered to discuss during the webinar.
This session is hosted by:
- Alison Orth - Unit Director, Clinical Trials BC
- Jean Smart - Regulatory Affairs & Quality Officer, Clinical Trials BC
Watch the recordings of ASK US's previous episodes: