Feasibility of placebo-controlled clinical trials of antipsychotic compounds in Europe

Rationale: Placebo-controlled trials (PCTs) are still regulatory requirements for the licensing of new drugs. Most recent phase II and phase III PCTs of anti-psychotics 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 I I 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.