CONSORT develops a checklist and guidelines for reporting in randomized platform trials (adaptive design)
The Consolidated Standards Of Reporting Trials (CONSORT) group published an extension for the reporting guidelines which takes into consideration the adaptive design of platform trials.
The CONSORT guidelines set the standard for reporting and publication elements of randomized clinical trials. This new extension covers new topics which are required for platform (adaptive) trials, as these trials have some unique aspects, notably the preplanned changes that can occur throughout an ongoing trial. This new, more flexible design, is accompanied by obstacles linked to the replicability of the study as well as the interpretation and synthesis of results. In order to overcome these hurdles greater transparency and reporting is essential.
The extension guideline was developed using a two-stage Delphi process with the input of key stakeholders in clinical trial research from 21 countries followed by a consensus meeting. It includes a checklist for adaptive design randomized trial reports and abstracts.
It will be important to keep in mind this amendment during trial set up so that the required information can be addressed in the study protocol from the start.
For more information see the full Extension