The present study was intended to comprehensively renew the guideline for the
protocol and important considerantions for the performance of clinical trial of drugs. In
this review, German Drug Act(Arzneimittelgesetz), GCP Guideline of the European
Union, various publications and my own experiences were refered.
The most important points are that clinical trials should be performed ethically as well
as scientifically. Therefore, trial protocols should be prepared to fulfill this respects.
Moreover, the protocols should be feasible. This means the protocol should be prepared
in consideration of the manpowers and facilities. The protocol should be placed on the
forcus on primary parameters. The number of subjects should be enough to evaluate
significant differences. Investigators should remember that people on the street are not
suitable as volunteer for clinical trials.
Compliance, sex, age, pharmacogenetics, body mass index, medication, anamnesis and
the results of biochemical screening test of volunteers should be considered to select
subjects. Foods, physical and psychological stresses are also important factors during
clinical trials. Informed consent should be written easily and lay, should inform to
subjects the objectives of trial, information of trial drugs, risks and profits from
participation of clinical trials.
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