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Strategies for obtaining unpublished drug trial data: a qualitative interview study
Nicole Wolfe1, Peter C Gøtzsche, Lisa Bero
1Department of Social and Behavioral Sciences, University of California, San Francisco, CA 94118, USA.
Systematic Reviews
|May 18, 2013
Summary
Systematic review authors face challenges accessing unpublished data. Obtaining this data is crucial for understanding drug harms and benefits, with a call for greater data accessibility and government intervention.
Area of Science:
- Medical Research Methodology
- Evidence Synthesis
- Drug Safety and Efficacy
Background:
- Authors of systematic reviews often struggle to access unpublished data.
- This study explores the experiences of systematic review authors in obtaining unpublished data.
- It aims to provide guidance on best practices for identifying, obtaining, and utilizing unpublished data.
Purpose of the Study:
- To describe the experiences of systematic review authors in searching for and accessing unpublished data.
- To identify challenges and facilitators in obtaining unpublished data for systematic reviews.
- To offer recommendations for best practices in managing unpublished data.
Main Methods:
- Qualitative study involving in-depth interviews with systematic review authors.
- Participants included first or senior authors of published systematic reviews on drug interventions.
- Interviewed authors had expertise in systematic reviews, data searching, and bias assessment.
Main Results:
- Authors had varied definitions of unpublished data.
- Contacting study authors was the primary method for data acquisition; regulatory agencies were underutilized.
- Data utilization was resource-intensive, requiring collaboration and specialized tools for extraction and analysis.
- A consensus existed on the importance of data accessibility, though concerns about sharing personal data were noted.
Conclusions:
- The effort to obtain unpublished data is valuable and necessary for accurately assessing drug harms and benefits.
- Increased availability of trial data, exemplified by the European Medicines Agency, may simplify data acquisition.
- There is strong support for government intervention to ensure open access to clinical trial data.
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