[The role of ethical committees in drug trials performed according to "Good Clinical Practice"].
According to the author, the prerequisites for the more active participation of Hungary in the international clinical drug research are the introduction of GCP and the limitation of the time needed for study approval to 3-4 months. The scientific and ethical aspects of the approval should be separated at each phase of drug development for securing a rapid and clear administrative approach. The first task falls into the domain of the appropriate national agency. In Hungary it is performed by experts whose activity is coordinated by the National Institute of Pharmacy (OGYI). On the other hand, it is the primary and exclusive responsibility of the Ethical Committees to supervise the safety of the trial subjects. The sponsor has to apply for the scientific-governmental approval, while trial permission from the Ethical Committee must be requested by the investigator(s). The latter contacts should be also meticulously documented according the guidelines of GCP. It is recommended that, in line with well-established international principles, all ethical problems related to drug development should be dealt with at local, hospital-based Ethical Committees. Furthermore, the continuous medical-social supervision demanded by GCP can be realised only through the conscientious work of the local committees. Any additional "official loops" will lead only to the prolongation of the trial approval and would result in a confusing bureaucratic process blurring the responsibility of the participants. For the safe functioning of the drug approval process an auditing system based on the cooperation of the Drug Regulatory Agency and the Scientific Ethical Committee of the Ministry of Public Welfare should be put in place urgently.(ABSTRACT TRUNCATED AT 250 WORDS)
Kerpel-Fronius
S
S
Országos Onkológiai Intézet, Budapest.
D002986:Clinical Trials as Topic; D004992:Ethics, Medical; D005060:Europe; D005062:European Union; D006814:Hungary; D014481:United States; D014486:United States Food and Drug Administration