Clinical Trial Transparency for FDA-Approved Drugs in 2012

318 clinical trials for 15 drugs approved by the FDA in 2012, involving 99,599 research participants. The dataset enables analysis of trial registration, results reporting, publication rates, and FDAAA compliance across 10 large biopharmaceutical companies. It was created by Jennifer E. Miller from sources including Drugs@FDA and ClinicalTrials.gov.

Use Cases

• Analyze variation in trial registration and publication rates across the 10 large biopharmaceutical companies.
• Assess compliance with FDAAA disclosure mandates for the subset of trials subject to the law.
• Calculate the proportion of research participants enrolled in trials that were not FDAAA-compliant.
• Rank the 15 approved drugs based on transparency criteria like registration and results reporting percentages.

Strengths

• Contains data on 318 clinical trials with a known participant count of 99,599.
• Focuses on a specific, policy-relevant cohort: all drugs approved by the FDA in a single year (2012).
• Provides drug-level summary statistics (medians and IQRs) for key transparency metrics.
• Explicitly identifies the number of research participants (33,405) in non-compliant FDAAA-subject trials.

Limitations

• Limited to drugs approved in a single year (2012), which may not reflect current practices.
• Analysis is at the drug and company level; individual trial records are not provided as rows.
• Data sources are secondary (regulatory and publication databases), potentially introducing reporting lag or gaps.

Provenance

Source

Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals, and drug company communications.

Collection Method

Cross-sectional analysis conducted by researchers.

Time Range

Clinical trials submitted for drugs approved by the FDA in 2012.

Freshness

Data reflects status as of the study's publication; last updated in the repository on 2020-06-24.

Geography

United States (FDA approvals).