title: Litigation seeking access to data from ongoing clinical trials: a threat to clinical research.
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.
authors.affiliation: Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Walter N
authors.initials: WN
authors.lastname: Kernan
authors.affiliation: Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Viscoli
authors.affiliation: Office of the General Counsel, Yale University, New Haven, Connecticut.
authors.forename: Mathew C
authors.initials: MC
authors.lastname: Varughese
mesh_terms: D022126:Access to Information / Q000331:legislation & jurisprudence*; D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D003237:Connecticut; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D033222:Judicial Role; D000077205:Pioglitazone; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence*; D055502:Secondary Prevention; D020521:Stroke / Q000517:prevention & control; D045162:Thiazolidinediones / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States; D001749:Urinary Bladder Neoplasms / Q000139:chemically induced*
chemical_list: D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077205:Pioglitazone