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News from the European Commision

News from the European Commision GOOD CLINICAL PRACTICE IN CLINICAL TRIALS In the proposal for a directive on Good Clinical Practice (GCP) in the conduct of clinical trials, several important issues were raised which are of interest to those of us involved in clinical trials for cancer. One of the most important was related to ethics. The notion of Ethical Committees is variable across Europe. It is proposed that independent ethics committees are established wherever a clinical trial is conducted. The membership should consist of doctors other than those involved in the trial, nurses and other health care professionals, as well as non-medical members such as lawyers, administrators and lay people. Whilst this may seem very familiar to some of us in Europe it is by no means standard across the EU. The important point is also made that each of the centres for the trial should give the same information to their ethics committees rather than writing something specific for the individual centre. Some of the other issues proposed are related to reporting on the progress of the trial, attrition rates, information giving to patients and their relatives and the role of the pharmaceutical industry. As more information becomes available we will pass it on to readers. Ref: COM 97 369 final. ISSN 0254-1475. European Journal of Cancer Care, 1998, 7, 11 # 1998 Blackwell Science Ltd. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Journal of Cancer Care Wiley

News from the European Commision

European Journal of Cancer Care , Volume 7 (1) – Mar 1, 1998

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Publisher
Wiley
Copyright
Copyright © 1998 Wiley Subscription Services, Inc., A Wiley Company
ISSN
0961-5423
eISSN
1365-2354
DOI
10.1046/j.1365-2354.1998.00074.x
Publisher site
See Article on Publisher Site

Abstract

GOOD CLINICAL PRACTICE IN CLINICAL TRIALS In the proposal for a directive on Good Clinical Practice (GCP) in the conduct of clinical trials, several important issues were raised which are of interest to those of us involved in clinical trials for cancer. One of the most important was related to ethics. The notion of Ethical Committees is variable across Europe. It is proposed that independent ethics committees are established wherever a clinical trial is conducted. The membership should consist of doctors other than those involved in the trial, nurses and other health care professionals, as well as non-medical members such as lawyers, administrators and lay people. Whilst this may seem very familiar to some of us in Europe it is by no means standard across the EU. The important point is also made that each of the centres for the trial should give the same information to their ethics committees rather than writing something specific for the individual centre. Some of the other issues proposed are related to reporting on the progress of the trial, attrition rates, information giving to patients and their relatives and the role of the pharmaceutical industry. As more information becomes available we will pass it on to readers. Ref: COM 97 369 final. ISSN 0254-1475. European Journal of Cancer Care, 1998, 7, 11 # 1998 Blackwell Science Ltd.

Journal

European Journal of Cancer CareWiley

Published: Mar 1, 1998

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