Author: Baruch A. Brody
Although most developed countries have extensive regulations governing the testing, approval and marketing of new drugs, there are major gaps in these regulations. In this compelling new volume, Dr. Brody uses the example of the development of
thrombolytic drugs to identify several such gaps.Issues addressed include the use of placebo control groups in
clinical trials, the importance of determining the type of consent that should be obtained for emergency research, and
ways to avoid conflicts of interest in clinical trials. He also discusses topics such as deciding to continue clinicaltrials or to approve a drug quickly, maintaining a proper balance between efficacy and safety in drug…
