Justification of clinical trials with updated systematic reviews: calling on the ICMJE to introduce publication requirements

Abstract It is a scientific principle to design new experiments based on previous discoveries and observations. In medical science, conducting and designing new randomized clinical trials of healthcare interventions should therefore be based on systematic assessments of the evidence on the topic. However, this is often not the case, and many clinical trials are not answering important clinical questions. Medical journals can positively change this by issuing explicit author requirements, similar to existing publication requirements of prospective trial registration and declaration of data sharing intentions. We therefore encourage medical journals to introduce new author requirements specifying that a systematic review of the evidence is undertaken before any new clinical trial is started; this should be documented in the protocol and in the final trial report. We discuss various challenges and how such requirements may affect the scientific ecosystem and give concrete solutions to make the proposal feasible.