In developed countries trial registration is becoming the norm—although many are still registered late4; conversely, trial results reporting is far from optimal.234 While the US4 and several EU countries5 are starting actively to promote trial results reporting, it is disappointing to observe how regulators from France, Italy, Spain, and Sweden “appear to be taking little or no action” in this respect.5 Acknowledging that pre-registering clinical trials and timely posting of results are the most relevant activities to help investigators, clinicians, and patients to make informed decisions, there are three additional actions that will enhance clinical trial transparency: the posting of protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) on the trial register. [...]they are highly compliant with regard to posting protocols and SAPs on ClinicalTrials.gov.8 To continue leading trial transparency, UK regulators should consider including the posting of trial protocols, SAPs, and ICFs on the trial register in any new legislation.9 Competing interests: www.govinfo.gov/content/pkg/FR-2017-01-19/pdf/2017-01058.pdf. 8 DeVito NJ Goldacre B. Evaluation of compliance with legal requirements under the FDA Amendments Act of 2007 for timely registration of clinical trials, data verification, delayed reporting, and trial document submission....

Is current UK transparency on clinical trials enough?

10.1136/bmj.p1933