US to impose tougher rules on reporting clinical trial data

Researchers conducting clinical trials in the US will be required to provide more information about their studies when they initially register their trials and more detailed results upon their trials’ completion under two sets of new rules.

The rules were released on 16 September by the US Department of Health and Human Services1 and the National Institutes of Health (NIH).2

Francis Collins, director of NIH, said that the new rules will help maximize the value of clinical trials and fulfill researchers’ commitment to trial participants. “Access to more information about clinical trials is good for patients, the public, and science,” Collins said.

Since 2007 researchers in the US have been required to register certain types of clinical trials and to report summary results on the website ClinicalTrials.gov, an online database maintained by the US National Library of Medicine that is open to the general public.

However, compliance with the reporting requirements has been poor, in part, health officials said, because ambiguity in the law has led researchers to be uncertain about what sorts of trials needed to be registered and what information needed to be reported. The new rules seek to clarify what kinds of studies are covered by the rules and who is responsible for making sure reporting is complete and timely.

The new requirements from the health department apply to most interventional studies of drugs or medical devices that have not yet been approved, licensed, or cleared by the Food and Drug Administration (FDA), but they do not apply to phase I trials or small feasibility studies of devices.1 The NIH rules, however, apply to all trials funded by NIH, including phase I clinical trials of FDA regulated products; small feasibility device trials; and interventions that are not regulated by the FDA, such as behavioral interventions. Investigators and institutions that fail to comply with the NIH rules will face loss of NIH funding.2

The new rules require that trials be registered no later than 21 days after enrolling the first participant. Registration information must include details about the study design, primary outcome measures, and recruitment information, such as who is eligible. A summary of results must be reported within 12 months of the date of the final data collection for the trial’s prespecified primary outcome measure, unless the trial involves a product under consideration for FDA approval, in which case it is possible to obtain a two year extension for reporting trial results. Required information about results includes demographics and baseline characteristics of participants, outcomes and statistical analysis of each primary and secondary outcome measure, adverse event information, and the full study protocol and statistical analysis plan.

The new rules go into effect on 18 January 2017. Trial sponsors and investigators will have 90 days to comply.

Information about the new rules and tools to help researchers meet the new requirements will be posted on the ClinicalTrials.gov website at https://prsinfo.clinicaltrials.gov.