W Wolfgang Fleischhacker1, Tom Burns. 1. Department of Biological Psychiatry, Innsbruck University Clinics, Anichstrasse 35, 6020 Innsbruck, Austria. wolfgang.fleischhacker@uibk.ac.at
Abstract
RATIONALE: Placebo-controlled trials (PCTs) are still regulatory requirements for the licensing of new drugs. Most recent phase II and phase III PCTs of antipsychotics in schizophrenia have been conducted outside Europe. This development needs to be better understood. OBJECTIVES: To ascertain the attitude of experienced European schizophrenia researchers to PCTs in acute and maintenance trials and identify national variations. METHODS: A postal questionnaire to recognised schizophrenia researchers across Europe. RESULTS: In all, 115 (77%) questionnaires were returned from 11 countries. There was considerable variation between countries in willingness to conduct PCTs in both acute and maintenance trials. Only 30% (acute trials), respectively 39% (maintenance trials) of the respondents said that they would participate in a PCT. Over one-third of investigators with previous experience of PCTs would not contemplate them now. Many cited the attitude of local ethics committees as the reason for their reluctance. CONCLUSIONS: PCTs are difficult to conduct in Europe. There are potential problems with importing results from one health care context into a significantly different one. The ethical and practical issues need to be addressed by a broad stakeholder group involving the industry, universities, ethics committees and users groups.
RATIONALE: Placebo-controlled trials (PCTs) are still regulatory requirements for the licensing of new drugs. Most recent phase II and phase III PCTs of antipsychotics in schizophrenia have been conducted outside Europe. This development needs to be better understood. OBJECTIVES: To ascertain the attitude of experienced European schizophrenia researchers to PCTs in acute and maintenance trials and identify national variations. METHODS: A postal questionnaire to recognised schizophrenia researchers across Europe. RESULTS: In all, 115 (77%) questionnaires were returned from 11 countries. There was considerable variation between countries in willingness to conduct PCTs in both acute and maintenance trials. Only 30% (acute trials), respectively 39% (maintenance trials) of the respondents said that they would participate in a PCT. Over one-third of investigators with previous experience of PCTs would not contemplate them now. Many cited the attitude of local ethics committees as the reason for their reluctance. CONCLUSIONS: PCTs are difficult to conduct in Europe. There are potential problems with importing results from one health care context into a significantly different one. The ethical and practical issues need to be addressed by a broad stakeholder group involving the industry, universities, ethics committees and users groups.
Authors: Robert P McMahon; Deanna L Kelly; Douglas L Boggs; Lan Li; Qiaoyan Hu; John M Davis; William T Carpenter Journal: Schizophr Bull Date: 2008-01-08 Impact factor: 9.306
Authors: Larry Alphs; Fabrizio Benedetti; W Wolfgang Fleischhacker; John M Kane Journal: Int J Neuropsychopharmacol Date: 2012-01-05 Impact factor: 5.176