Acceptability and profile of the clinical drug trials underway in Finnish university hospitals in the 1990s: applications reviewed by ethics committees.
There is scarce information in literature about the decisions made by ethics committees concerning the clinical studies they have reviewed. A retrospective, detailed review of 666 applications, their amendments and the ethics committees' statements was undertaken. All protrocols of clinical studies on medicinal products submitted to and reviewed by the ethics committees of two university hospitals during the years 1992, 1994, 1996 and 1998 were investigated. Most of the studies were international (50%), multicenter (71%), phase III trials (41%) on a new clinical entity, (38%). Validity of the clinical drug study applications was acceptable in more than half of the cases (364; 55%), while 91 (14%) were approved with advisory comments, 153 (23%) had to be amended, 35 (5%) were left pending and 23 (3%) were rejected. Most of the questions pertained to informed consent and the study protcol. In accordance with precious results, our findings support the opinion that the submitted documents need to be improved, especially with regard to informed consent and study protocols, in order to gain better Good Clinical Practice (GCP) compliance. Well-defined, documented operating procedures of the ethics committees would have facilitated the practical issues in the review process.
Canadian Association for Immunization Research and Evaluation (CAIRE) guidelines for industry-sponsored clinical trial and epidemiology contract research.
In response to concerns about interactions of academic and public health investigators with industry, the Canadian Association for Immunization Research and Evaluation (CAIRE), in collaboration with six major vaccine manufacturers, developed guidelines for participation in industry-sponsored clinical trial and epidemiology contract research within Canada. Topics addressed include definition of investigators, data ownership, protocol development, data management, data analysis, producing a study report and publication of the results of the study.
All major drug agencies in the world have now implemented, or have at least shown interest in, Good Clinical Practice (GCP) standards as an important part of their regulation of clinical trials. This is increasingly considered as a logical part of drug regulation in general, because the data produced in trials will later be evaluated by the government agencies, and the quality of trials and data must therefore be assured. Another significant effect of GCP will be caused by the ties between ethics, public health and scientific standard referred to in many of the requirements. This means that GCP may eventually have an impact on the entire clinical research programme, including nonregulatory projects (possibly the majority), because the same standard must apply throughout. Harmonisation is well under way internationally for both GCP and clinical trial regulation. This should also extend to the handling of scientific misconduct, the influence of GCP on health economics and the establishment of ethics committee systems. International data bases may obviously be required. Finally, the ultimate goal, the benefit for patients and society, must not be obscured by the mechanics of improving clinical trials and the harmonisation of regulations, and the investigator should maintain a key position in clinical drug development under the new regulatory conditions.
