Litigation seeking access to data from ongoing clinical trials: a threat to clinical research.
Where this comes from
- Record sourced from PubMed, PMID 25047222.
- Also identified by DOI 10.1001/jamainternmed.2014.3248 and PMC identifier 5758866.
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Abstract
Researchers conducting randomized clinical trials may find themselves subject to legal subpoenas for interim data. When a subpoena demands premature disclosure of unblinded data, there is potential for damage to the scientific integrity and reputation of the on-going trial. We describe herein general issues raised by subpoenas for trial data and the particular case of a 2012 subpoena served on investigators from Yale University who were successful in winning reprieve from Connecticut Superior Court.
Medical subject headings
- Access to Information
- Biomedical Research
- Hypoglycemic Agents
- Randomized Controlled Trials as Topic
- Thiazolidinediones
- Urinary Bladder Neoplasms