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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- Unpublished evidence;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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