Skip to main content
Search
Please wait while the transcript is being prepared...
0:00
My name is Dr. Wayne Carter. The title of this lecture is Clinical Trials.
0:08
Drug testing in humans. Drug testing in humans is initiated after compound optimisation, after the formulation has been developed, and a route of administration has been finalised in an animal model. There's a need to establish a safety and efficacy profile prior to market approval of the drug. Clinical trials are undertaken and separated into four milestones: Phases I to IV.
0:37
Phases of clinical trials. In phase I, a safety profile and pharmacokinetics are established. In phase II, using a pilot or a relatively low number of humans, studies are undertaken to establish safety and efficacy in the target patient population. In phase III, a larger human study is undertaken in the target population to further establish safety and efficacy, and establish the benefit and efficacy versus the risk of adverse effects. In phase IV, this is a post-approval safety and drug effectiveness follow-up.
1:17
Phase I, safety first. First-in-human, that is phase I, provides a provisional test of safety and may also consider efficacy. A single ascending dose (SAD) or multiple ascending dose (MAD) is undertaken to determine the maximum tolerated dose (MTD) that produces dose-limiting toxicity, in other words, side effects. This provides an insight into also the human pharmacokinetic profile. Typically, this is undertaken with healthy volunteers (20 to 100) and can take up to 18 months to complete. It can be undertaken to consider a test group versus a placebo group, but not always. But the results are obtained and provide the basis for phase II dosing.

Quiz available with full talk access. Request Free Trial or Login.