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Authors' reports about research integrity problems in clinical trials.
William Gardner1, Charles W Lidz, Kathryn C Hartwig
1Department of Pediatrics and Children's Research Institute, Ohio State University, Columbus, OH, USA. gardnerw@pediatric.ohio-state.edu
Contemporary Clinical Trials
|April 20, 2005
Summary
Research integrity issues like data fabrication and misrepresentation in pharmaceutical clinical trials are infrequent per report. However, scientists frequently encounter such misconduct during their careers, necessitating robust prevention strategies.
Area of Science:
- Medical Research
- Clinical Trials
- Scientific Integrity
Background:
- Limited data exists on the prevalence of research integrity issues in scientific literature.
- The study aimed to assess the frequency of reported data fabrication or misrepresentation in pharmaceutical clinical trials.
Purpose of the Study:
- To quantify the occurrence of research integrity problems in published pharmaceutical clinical trials.
- To understand the extent to which authors report misconduct in their own or known studies.
Main Methods:
- A mail survey was distributed to 549 authors of pharmaceutical clinical trials published between 1998 and 2001.
- Authors were queried about fabrication or misrepresentation in their target study, their own past studies, or studies they were aware of.
Main Results:
- A 64% response rate was achieved from authors with valid addresses.
- 1% of authors reported misrepresentation in the target article; nearly 5% reported it in studies they participated in.
- 17% of authors knew of fabrication or misrepresentation from non-published sources.
Conclusions:
- While fraud per published report is rare, scientists have a high likelihood of encountering it during their careers.
- The observed frequency of research misconduct justifies strong preventative measures.
- Addressing research integrity is crucial for maintaining trust in clinical trial outcomes.