COVID-19 transformed every aspect of our lives and healthcare, but it also disrupted thousands of clinical trials involving hundreds of thousands of participants, and billions of dollars of scientific investment. Numerous trials that were underway prior to the COVID-19 pandemic had to undergo necessary modifications, such as changes to methods of recruitment, intervention delivery, statistical analysis, and more. Researchers now have to figure out what to do with these disruptions, how to make sense of their results, and how to report these unexpected modifications transparently.
To assist researchers in the task of deciding what information to include in a trial protocol or a completed trial article after their study had to undergo modifications due to COVID-19, an international team of trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors developed the CONSERVE Statement.
CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) was developed using a consensus process, a rapid review, and a survey of the international trials community and offers guidance for reporting trials and trial protocols that undergo important modifications. Clinical Trials Ontario worked with its network of health charities and patient organizations as well as the College of Lived Experience to bring patient, public and participant perspectives to these guidelines. The guidelines have the ability to help improve the transparency, quality, and completeness of the reporting of trials during the COVID-19 pandemic.