By Ioannis Mountziaris
The field of chemical biology has developed a broad toolset for the development of new therapeutics. Our expanding knowledge of biological mechanisms led to the identification of novel drug targets and the development of new drug candidates. But to bring the discoveries from the academic and industrial labs to patients, the drug must pass through FDA clinical trials, at medical schools such as UCSF.
During his recent talk, Dr. Rahul Aggarwal, an Assistant Clinical Professor at UCSF, focused on answering how drug candidates undergo phase I clinical trials. With the limited number of patients available for drug trials, a significant amount of in vitro and in vivo evidence is required from research scientists, including the pharmacodynamics, drug targets, and mechanism of action. Only upon passing FDA vetting can a clinical trial begin, with the first interest being the determination of the range of doses possible for the drug in question, with a determination of efficacy of the drug a bonus. The average phase I trial has less than twenty patients, limiting the number of samples available to test and time period for safe and effective dose determination. The most surprising aspect of clinical trials is their codependence on both academics, to execute the study, and industry, which are the primary financiers of drug testing. This relationship is a philosophical and legal minefield, where researchers and doctors have to weigh their relationships with their patients with the desires to develop new and effective drugs.