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Making available information from studies sponsored by the pharmaceutical industry: some current practices
Michael O'Kelly1, Steven A Julious, Stephen Pyke
1Quintiles Ireland Ltd, Dublin, Ireland. mokelly@quintiles.com
Pharmaceutical Statistics
|January 29, 2011
Summary
Since 2000, the pharmaceutical industry has increased clinical trial data transparency via registries like ClinicalTrials.gov. This review examines the history, challenges, and consistency of public clinical trial information sharing.
Area of Science:
- Clinical trial transparency
- Pharmaceutical industry data sharing
- Regulatory compliance in research
Background:
- The launch of ClinicalTrials.gov in 2000 marked a significant shift towards public disclosure of clinical trial information.
- Increasing pharmaceutical industry involvement in clinical trials necessitates robust data sharing mechanisms.
- Multiple stakeholders influence the definition and scope of publicly available clinical trial data.
Purpose of the Study:
- To review the historical evolution of making clinical trial information publicly accessible.
- To provide a guide to existing clinical trial registries and results databases.
- To assess indicators of consistency in the reporting of clinical trial study information.
Main Methods:
- Historical review of public disclosure policies for clinical trials.
- Analysis of the development and impact of ClinicalTrials.gov.
- Examination of data consistency metrics across study registries.
Main Results:
- A growing trend in pharmaceutical companies sharing clinical trial data since 2000.
- The increasing complexity of data sharing due to multiple institutional interests.
- Identification of key registries and databases for accessing trial outcomes.
- Preliminary indicators suggest variability in the consistency of posted study information.
Conclusions:
- The journey towards public clinical trial data transparency has been complex and ongoing.
- Effective navigation of registries and databases is crucial for researchers and the public.
- Further efforts are needed to ensure consistent and reliable reporting of clinical trial information.
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