Clinical trial registration, reporting, publication and FDAAA compliance: unacceptably low

More drug trial data should be online

image of clinical-trials
Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Clinical Trials by Sanofi Pasteur.

2015 Study Abstract

Leading clinical research authorities are calling for more aggressive enforcement of requirements for public reporting of the results of experimental drug trials, in response to a recent STAT investigation that found widespread failures by eminent universities and pharmaceutical firms to file data on their clinical trials.

Objective
To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge.

Design
Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies.

Data sources
Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications.

Main outcome measures
Clinical trial registration and results reporting in ClinicalTrials.gov, publication in the medical literature, and compliance with the 2007 FDA Amendments Acts (FDAAA), analysed on the drug level.

Results
The FDA approved 15 drugs sponsored by 10 large companies in 2012. We identified 318 relevant trials involving 99 599 research participants. Per drug, a median of 57% (IQR 32–83%) of trials were registered, 20% (IQR 12–28%) reported results in ClinicalTrials.gov, 56% (IQR 41–83%) were published, and 65% (IQR 41–83%) were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed phase II or III trial. Per drug, a median of 17% (IQR 8–20%) of trials supporting FDA approvals were subject to FDAAA mandated public disclosure; of these, a median of 67% (IQR 0–100%) were FDAAA-compliant. 68% of research participants (67 629 of 99 599) participated in FDAAA-subject trials, with 51% (33 405 of 67 629) enrolled in non-compliant trials. Transparency varied widely among companies.

Conclusions
Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve compliance with legal and ethics standards and the quality of medical knowledge.

Sources and more information
  • Health officials call for better enforcement on clinical trial reporting, STAT news, DECEMBER 22, 2015.
  • Do drug-firm ties affect researchers’ reporting of study results?, STAT news, DECEMBER 18, 2015.
  • More drug trial data should be online, bostonglobe, DECEMBER 14, 2015.
  • Top institutions not reporting clinical trial results as required, STAT news, DECEMBER 13, 2015.
  • Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012, BMJ Open doi:10.1136/bmjopen-2015-009758, 12 November 2015.

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