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Scientific Data From Clinical Trials

Scientific Data From Clinical Trials SPECIAL ARTICLE Investigators’ Responsibilities and Rights 1-9 ased on recent reports, there are increasing concerns about the control of the scien- tific data obtained from clinical trials sponsored by industry. Many of the problems en- countered are the result of restrictions contained in the research contracts that partici- B pating investigators are asked to sign. A number of solutions have been suggested to ensure the integrity of clinical trials, including the establishment of appropriately constituted trial oversight committees, negotiating noninterference pledges from industry sponsors, and creating proactive support of investigators’ rights by organized medicine. As surgical journal editors, we stand op- have sole control of the data or to with- posed to inappropriately restrictive con- hold publication.” tractual agreements governing company- Editors may choose not to publish an sponsored clinical trials of devices or drugs, article if the sponsor had control over the such as those containing clauses that deny trial design, data analysis, and/or publi- cation. These requirements for publica- the investigators proper control over the tion ethics were adopted as policy on May scientific aspects of the trial or restrict ac- 11, 2001, and will be included in the next cess to the data and its timely http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Surgery American Medical Association

Scientific Data From Clinical Trials

JAMA Surgery , Volume 137 (6) – Jun 1, 2002

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Publisher
American Medical Association
Copyright
Copyright 2002 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6254
eISSN
2168-6262
DOI
10.1001/archsurg.137.6.639
Publisher site
See Article on Publisher Site

Abstract

SPECIAL ARTICLE Investigators’ Responsibilities and Rights 1-9 ased on recent reports, there are increasing concerns about the control of the scien- tific data obtained from clinical trials sponsored by industry. Many of the problems en- countered are the result of restrictions contained in the research contracts that partici- B pating investigators are asked to sign. A number of solutions have been suggested to ensure the integrity of clinical trials, including the establishment of appropriately constituted trial oversight committees, negotiating noninterference pledges from industry sponsors, and creating proactive support of investigators’ rights by organized medicine. As surgical journal editors, we stand op- have sole control of the data or to with- posed to inappropriately restrictive con- hold publication.” tractual agreements governing company- Editors may choose not to publish an sponsored clinical trials of devices or drugs, article if the sponsor had control over the such as those containing clauses that deny trial design, data analysis, and/or publi- cation. These requirements for publica- the investigators proper control over the tion ethics were adopted as policy on May scientific aspects of the trial or restrict ac- 11, 2001, and will be included in the next cess to the data and its timely

Journal

JAMA SurgeryAmerican Medical Association

Published: Jun 1, 2002

References

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