The Central Register of Clinical Trials: Current Status of Clinical Research in Poland
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0092-8615/97 Copyright Q 1997 Drug Information Association Inc.
THE CENTRAL REGISTER OF CLINICAL TRIALS: CURRENT STATUS OF CLINICAL RESEARCH IN POLAND ANDRZEJCZARNECKI, MD, PHD, DSc Director, Central Register of Clinical Trials, Drug Institute, Warszawa,Poland
The European Community Directive for good clinical practice (GCP) was introduced as a requirement of the Ministry of Health and Social Welfare in Poland in January 1993. The Central Register of Clinical Trials (CRCT) was established 16 months later: Since then, the CRCT had to be notified of all studies involving patients according to established rules. New requirements and procedures made the system transparent and it was generally accepted by sponsors. The approval time was shortenedfrom unpredictable to 42 calendar days. Therefore, the number of studies, including multinational ones, increased. The CRCT was notified about more than 300 clinical trials covering numerous areas of medical research during the covered period of time (23 months). They were organized and supervised by local and foreign companies and contract research organizations. The quality of local clinical research improved substantially due to additional GCP training and consulting activities. Recently, the attempt to unifr ethics committees’ requirements and transparency of their work was undertaken. Moreover, in the near future regulatory GCP inspection should be implemented Key Words: Clinical trials; National register; Regulatory control of clinical trials
INTRODUCTION IN JANUARY 1993, the Ministry of Health and Social Welfare (MoH) in Poland introduced the European Community Directive for good clinical practice as a requirement for conducting clinical trials in the country (1). The document was translated into Polish and broadly disseminated. The GCP directive as well as the World Health Organisation (WHO) recommendation suggest that clini-
Resented at the DIA 8th Euromeeting, May 543,1996, Copenhagen, Denmark. Reprint address: Professor Andrzej Czamecki, Drug Institute, Chehnska 30/34, PL-00 725 Warszawa, Poland.
cal trials be registered in every country. According to this recommendation and local need, in 1994 the Department of Science and Education of the MoH established the Central Register of Clinical Trials which was located in the Drug Institute. Since April 15, 1994 the CRCT had to be notified of all clinical studies, Phase I-IV, concerning drugs and other medical devices on the Polish market. The application for trial approval is to be done on the nine-page Clinical Trial Notification Form (Figure 1 shows page 1). Requested information includes: substance to be tested, status of the drug, type of study, research hypothesis, monitoring arrangements, investigators, study sites, and some other issues. The form has to be filled in by
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