Footnotes

• Twitter @AnisaFarid, @RIATinitiative

• Contributors ST and PD conceptualised the article and ST wrote the first draft. AR-F and KH led the data extraction and analysis. All authors (ST, AR-F, KH, TJ, PD) were involved in reviewing and editing the final manuscript.

• Funding The Laura and John Arnold Foundation funds the RIAT Support Center, which supports the salaries of ST, AR-F, KH, TJ and PD.

• Disclaimer The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS, The University of Maryland, or the US Government.

• Competing interests KH was supported by the Food and Drug Administration (FDA) of the US Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946, unrelated to this manuscript, totaling US$5000 with 100% funded by FDA/HHS. PD has received travel funds from the European Respiratory Society (2012) and Uppsala Monitoring Center (2018); grants from the FDA (through University of Maryland M-CERSI; 2020), Laura and John Arnold Foundation (2017–2022), American Association of Colleges of Pharmacy (2015), Patient-Centered Outcomes Research Institute (2014–2016), Cochrane Methods Innovations Fund (2016-2018) and UK National Institute for Health Research (2011–2014); was an unpaid IMEDS steering committee member at the Reagan-Udall Foundation for the FDA (2016–2020), and is an editor at The BMJ. The Laura and John Arnold Foundation funds the RIAT Support Center, which supports the salaries of ST, ARF, KH, TJ, and PD. TJ’s competing interests are online (https://restoringtrials.org/competing-interests-tom-jefferson/).

• Provenance and peer review Commissioned; externally peer reviewed.