Consensus statement on scientific data from clinical trials and investigators’ responsibilities and rights

• Published in: The American journal of surgery Vol. 183; no. 6; pp. 605 - 606
• Main Authors: Polk, Jr, Hiram C, Bowden, Jr, Talmadge A, Rikkers, Layton F, Balch, Charles M, Organ, Claude H, Murie, John A, Pories, Walter J, Buechler, Markus W, Neoptolemos, John P, Fazio, Victor W, Schwartz, Seymour I, Cameron, John L, Kelly, Keith A, Grosfeld, Jay L, McFadden, David W, Souba, Wiley W, Pruitt, Jr, Basil A, Johnson, K Wayne, Rutherford, Robert B, Arregui, Maurice E, Scott-Conner, Carol E, Warshaw, Andrew L, Sarr, Michael G, Cuschieri, Alfred, MacFadyen, Bruce V, Tompkins, Ronald K
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-06-2002; Elsevier Limited
• Subjects: Authorship; Bias; Clinical trials; Clinical Trials as Topic - standards; Conflict of Interest; Contract Services; Corporate sponsorship; Data analysis; Decision analysis; Drug Industry; Endoscopy; Ethics, Professional; Medical research; Publishing - standards; Research Support as Topic; Surgery
• ISSN: 0002-9610; 1879-1883
• DOI: 10.1016/S0002-9610(02)00873-5

Recently, the editors of 13 medical journals also published their opposition to inappropriately restrictive research contracts, insisting that investigators be given and assume adequate responsibility for the conduct of a clinical trial, have sufficient access to the data to perform the necessary analyses, and have control over the decision to publish. Authors should describe the role of the study sponsor(s), if any, in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the report for publication. Biases potentially introduced when sponsors are directly involved in research are analogous to methodological biases of other sorts; some journals therefore choose to include information about the sponsor’s involvement in the methods section of the published paper.If a study is funded by an agency with a proprietary or financial interest in the outcome, editors may ask authors to sign a statement such as, “I had full access to all of the data in this study and I take complete responsibility for the integrity of the data and the accuracy of the data analysis.”