Clinical trials in Israel. Criteria for approval.

: Approval by the Ministry of Health is required prior to the use in man of any chemical compound, including recognized drugs that have not been registered for marketing in Israel. As a rule, drugs are permitted for use in experimental treatment of human beings only after they have been thoroughly tested in animals and when a justified rationale has been provided. General outlines regarding required animal tests are available. Indications other than those for which a drug has been registered or dosages several times exceeding those recommended are dealth with as new compounds. Only physicians licensed in Israel may apply for permission to perform clinical trials. The responsibility for conducting a trial lies with the experimenting physician and the institution under whose auspices the study is carried out. Further principles concerning clinical trials in Israel include such issues as: 1) What type of basic information (rationale, safety, quality, etc.) must be provided before approval is granted? 2) Which population groups should in principle be excluded from human experimentation? 3) Should clinical trials be restricted to those for whom therapy may be directly beneficial? A number of clinical trials considered in the past by the Ministry's Committee illustrate the Israeli approach to clinical trials.