Open AccessSystems for ethics review of multicentre trials
Author(s) -
Tassig JeanPierre
Publication year - 1997
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/(sici)1099-1786(1997120)2:4<187::aid-qaj49>3.0.co;2-v
Subject(s) - declaration of helsinki , clinical trial , multinational corporation , ethics committee , research ethics , declaration , informed consent , helsinki declaration , political science , medicine , public relations , law , alternative medicine , engineering ethics , public administration , engineering , pathology
The multinational multicentre clinical trial has become the most important drug development tool today. Such a trial is a complex system involving investigator networks and sponsor consortia spreading across nations, races and cultures. Yet, the Declaration of Helsinki and ICH GCP still consider the clinical trial from the one sponsor/one investigator/one country point of view. The legal structure, based on national law, has taken precedence over the reality of transnational projects. As a result, multinational clinical trials are being impeded by all sorts of barriers, which lead to delays and wasteful accumulation of administrative procedures. In particular, the ethics review process has become a patchwork of local reviews at the bottom of the system. Paradoxically, there is no review of the ethics of the whole multicentre study at the top of the system. Hence, multicentre protocols follow the path of least resistance, as negative opinions from more resistant sites are circumvented by the opening of new sites. The issues are that, on the one hand, there is no sponsor‐independent body to take responsibility for the overall ethics of the trial, nor the role the trial fulfils in the international development plan, and on the other hand, a lot of effort is required at the local level for ethics decisions concerning blocks of N =4–12 patients at each individual site. Certain countries, including France, Germany and Russia, do recognise the specificity of multicentre studies, and have organised a pyramidal review starting from the top of the system, where N is in the hundreds, sometimes in the thousands. In large territories, like North America and Russia, the ethics review of multicentre studies is faster than in Western Europe, where the subsidiarity principle appears to paralyse progress towards harmonisation. The author suggests that Europe should recognise the specificity of the multinational multicentre trial, and focus on the efficiency of a pan‐European ethics review process. © 1997 John Wiley & Sons, Ltd.