n Southern African Journal of HIV Medicine - Horizons
|Journal||Southern African Journal of HIV Medicine|
|Publication Date||Mar 2006|
Extracted from text ... H O R I Z O N S TRIALS AND TRIBULATIONS The medical maxim of 'First do no harm' is never more relevant than during development of a medicinal agent or intervention, whether it be drug, vaccine, diagnostic or procedure. Over many years a phased clinical trial process has been developed along with safety and monitoring processes to ensure human subject dignity, privacy and autonomy, and the minimisation of risk as well as research integrity. Before any testing in human subjects the process involves pre-clinical work, including toxicity studies, wherever possible in animal models. Human subject testing then follows with phase 1 trials, often in small numbers (10 - 100) of ..
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