Data from: Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012

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.