Litigation seeking access to data from ongoing clinical trials: a threat to clinical research

Walter N Kernan; Catherine M Viscoli; Mathew C Varughese

doi:10.1001/jamainternmed.2014.3248

Litigation seeking access to data from ongoing clinical trials: a threat to clinical research

JAMA Intern Med. 2014 Sep;174(9):1502-4. doi: 10.1001/jamainternmed.2014.3248.

Authors

Walter N Kernan¹, Catherine M Viscoli¹, Mathew C Varughese²

Affiliations

¹ Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
² Office of the General Counsel, Yale University, New Haven, Connecticut.

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.

Publication types

Research Support, N.I.H., Extramural

MeSH terms

Access to Information / legislation & jurisprudence*
Biomedical Research / legislation & jurisprudence*
Connecticut
Diabetes Mellitus, Type 2 / drug therapy
Humans
Hypoglycemic Agents / adverse effects
Hypoglycemic Agents / therapeutic use*
Judicial Role
Pioglitazone
Randomized Controlled Trials as Topic / legislation & jurisprudence*
Secondary Prevention
Stroke / prevention & control
Thiazolidinediones / adverse effects
Thiazolidinediones / therapeutic use*
United States
Urinary Bladder Neoplasms / chemically induced*

Substances

Hypoglycemic Agents
Thiazolidinediones
Pioglitazone

Grants and funding

U01 NS044876/NS/NINDS NIH HHS/United States