New Requirements in the Reporting of Randomized Controlled Trials Published in Neurology to Foster Greater Transparency

The results of randomized controlled trials (RCTs) are essential for making decisions about preventive interventions, behavioral changes, clinical care, and public policy. Reports of RCTs must, therefore, be transparent, accurately represent what the investigators set out to do, and contain all the elements that are required for readers to appraise the methods and results adequately. This includes the ability to identify potential sources of bias and interpret the magnitude and relevance of the findings. Over the past few decades, several initiatives have fostered comprehensive and transparent reporting of clinical trials. Starting in 1996, the Consolidated Standards of Reporting Trials (CONSORT) statement promotes adequate reporting of all elements needed for the appraisal of published trials through checklists.^1-3 Clinical trial registries, proposed in the 1980s,⁴ provide a time-stamped record of the prespecified trial design, the outcomes, and the proposed sample size. These registries are powerful tools for identifying selective outcomes reporting and deviations from trial protocols. Both the International Committee of Medical Journal Editors (ICMJE) and the Declaration of Helsinki require public registration of any clinical trial before the first participant is enrolled for the trial to be published.⁵ The ICMJE recognizes registration in any of the primary registries that participate in the WHO International Clinical Trials Portal,⁶ including ClinicalTrials.gov.⁷ Based on this guidance, many countries have enacted laws mandating the prospective registration of clinical trials, particularly if their results will be used for regulatory treatment approval.⁸ In addition, many medical journals, including Neurology®, ask authors of clinical trial reports to provide a copy of the protocol and statistical analysis plan (SAP) for review.