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Thursday, November 10, 2016

Timing of pivotal clinical trial results reporting for newly approved medications varied by reporting source



abstract

Objective

The study aimed to characterize the public availability of pivotal clinical trial results for newly approved drugs.

Study Design and Setting

We examined the availability of pivotal clinical trial results for new molecular entities (NMEs) approved by the US Food and Drug administration (FDA) from 2009 to 2013. For each NME, we quantified the time from approval date until results were available on the FDA web site, in the ClinicalTrials.gov basic results database, and in a medical journal.

Results

Two hundred fifty-five pivotal trials supporting 88 NMEs met our criteria. The median time until pivotal trial results were available on the FDA web site, ClinicalTrials.gov, and in a publication was 42 days, 27 days, and −28 days, respectively. In the first 30 days after approval, 52% of pivotal trials were summarized in ClinicalTrials.gov, 20% were posted to the FDA web site, and 46% were published in a journal. Across all sources, 79% of pivotal trials had results available within 30 days of approval. From 2009 to 2013, the average time until public availability has improved for federal sources.

Conclusions

Pivotal trials of newly approved drugs appeared first in publications. Results from most pivotal trials were publicly available in some source within 30 days of approval.

Keywords

  • Unpublished evidence;
  • Clinical trial reporting;
  • US Food and Drug administration;
  • Clinical trial registries
Funding: D.M.H. has grant funding from the US Centers for Disease Control (U01 CE002500 02) and Agency for Healthcare Research and Quality (R18 HS024227 01).

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