Clinical trials in Israel--facts and dilemmas.
A total of 1,186 proposals of clinical trials have been studied by the National Committee for Clinical Trials (NCCT) in 1995, with an annual increase of 15-20% since 1991. Of those, 61.4% dealt with drugs, the others-with medical instruments and techniques. As many proposals were part of multi-center studies, altogether 524 different drug-trials were studied, the leading fields being cardiovascular, nephrology, neurology, oncology, and infectious diseases in this order of importance. Forty two different proposals (8%) were discussed in depth in the NCCT while 92% were approved by hospital-committees and representatives of the national committee. Out of the 44 problematic proposals, discussed by the NCCT, .5 proposals were totally rejected, while 9 were approved following changes suggested by the committee. The ethical, moral and legal dilemmas presented by the proposals will be discussed.
Kishon
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National Committee for Clinical Trials (Drugs), Ministry of Health, Israel.
D002986:Clinical Trials as Topic / Q000592:standards*; D005069:Evaluation Studies as Topic; D006805:Human Experimentation; D006801:Humans; D007557:Israel; D018579:Patient Selection