Scientific data from clinical trials: Investigators' responsibilities and rights

Hiram C. Polk; Talmadge A. Bowden; Layton F. Rikkers; Charles M. Balch; Claude H. Organ; John A. Murie; Walter J. Pories; Markus W. Buechler; John P. Neoptolemos; Victor W. Fazio; Seymour I. Schwartz; John L. Cameron; Keith A. Kelly; Jay L. Grosfeld; David W. McFadden; Wiley W. Souba; Basil A. Pruitt; K. Wayne Johnston; Robert B. Rutherford; Maurice E. Arregui; Carol E.H. Scott-Conner; Andrew L. Warshaw; Michael G. Sarr; Alfred Cuschieri; Bruce V. MacFadyen; Ronald K. Tompkins

Scientific data from clinical trials: Investigators' responsibilities and rights

Hiram C. Polk, Talmadge A. Bowden, Layton F. Rikkers, Charles M. Balch, Claude H. Organ, John A. Murie, Walter J. Pories, Markus W. Buechler, John P. Neoptolemos, Victor W. Fazio, Seymour I. Schwartz, John L. Cameron, Keith A. Kelly, Jay L. Grosfeld, David W. McFadden, Wiley W. Souba, Basil A. Pruitt, K. Wayne Johnston, Robert B. Rutherford, Maurice E. ArreguiCarol E.H. Scott-Conner, Andrew L. Warshaw, Michael G. Sarr, Alfred Cuschieri, Bruce V. MacFadyen, Ronald K. Tompkins

Gastroenterologic and General Surgery

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

Based on recent reports, there are increasing concerns about the control of the scientific data obtained from clinical trials sponsored by industry. Many of the problems encountered are the result of restrictions contained in the research contracts that participating 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.

Original language	English (US)
Pages (from-to)	639-640
Number of pages	2
Journal	Archives of Surgery
Volume	137
Issue number	6
State	Published - 2002

ASJC Scopus subject areas

Surgery

Cite this

Polk, H. C., Bowden, T. A., Rikkers, L. F., Balch, C. M., Organ, C. H., Murie, J. A., Pories, W. J., Buechler, M. W., Neoptolemos, J. P., Fazio, V. W., Schwartz, S. I., Cameron, J. L., Kelly, K. A., Grosfeld, J. L., McFadden, D. W., Souba, W. W., Pruitt, B. A., Johnston, K. W., Rutherford, R. B., ... Tompkins, R. K. (2002). Scientific data from clinical trials: Investigators' responsibilities and rights. Archives of Surgery, 137(6), 639-640.

Polk, HC, Bowden, TA, Rikkers, LF, Balch, CM, Organ, CH, Murie, JA, Pories, WJ, Buechler, MW, Neoptolemos, JP, Fazio, VW, Schwartz, SI, Cameron, JL, Kelly, KA, Grosfeld, JL, McFadden, DW, Souba, WW, Pruitt, BA, Johnston, KW, Rutherford, RB, Arregui, ME, Scott-Conner, CEH, Warshaw, AL, Sarr, MG, Cuschieri, A, MacFadyen, BV & Tompkins, RK 2002, 'Scientific data from clinical trials: Investigators' responsibilities and rights', Archives of Surgery, vol. 137, no. 6, pp. 639-640.

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abstract = "Based on recent reports, there are increasing concerns about the control of the scientific data obtained from clinical trials sponsored by industry. Many of the problems encountered are the result of restrictions contained in the research contracts that participating 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.",

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T1 - Scientific data from clinical trials

T2 - Investigators' responsibilities and rights

AU - Polk, Hiram C.

AU - Bowden, Talmadge A.

AU - Rikkers, Layton F.

AU - Balch, Charles M.

AU - Organ, Claude H.

AU - Murie, John A.

AU - Pories, Walter J.

AU - Buechler, Markus W.

AU - Neoptolemos, John P.

AU - Fazio, Victor W.

AU - Schwartz, Seymour I.

AU - Cameron, John L.

AU - Kelly, Keith A.

AU - Grosfeld, Jay L.

AU - McFadden, David W.

AU - Souba, Wiley W.

AU - Pruitt, Basil A.

AU - Johnston, K. Wayne

AU - Rutherford, Robert B.

AU - Arregui, Maurice E.

AU - Scott-Conner, Carol E.H.

AU - Warshaw, Andrew L.

AU - Sarr, Michael G.

AU - Cuschieri, Alfred

AU - MacFadyen, Bruce V.

AU - Tompkins, Ronald K.

PY - 2002

Y1 - 2002

N2 - Based on recent reports, there are increasing concerns about the control of the scientific data obtained from clinical trials sponsored by industry. Many of the problems encountered are the result of restrictions contained in the research contracts that participating 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.

AB - Based on recent reports, there are increasing concerns about the control of the scientific data obtained from clinical trials sponsored by industry. Many of the problems encountered are the result of restrictions contained in the research contracts that participating 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.

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AN - SCOPUS:0036275838

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ER -

Scientific data from clinical trials: Investigators' responsibilities and rights

Abstract

ASJC Scopus subject areas

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