USCACA clinical trial education program
The phenomenal expansion of our knowledge in molecular biology of cancer in the last decade has led to an unprecedented number of exciting new targets for cancer treatment. A typical oncology drug candidate has many developmental opportunities as determined by line of therapy and tumor type, making it a hard decision as how to proceed amid uncertainties inherent in preclinical and early clinical data (dosing schedules, combination therapies and existence of a possible response signature further complicates the issue.)
It is an utmost challenge to oncology researchers and drug developers to find the best development strategies in investigating promising drug candidates under resource constraint.
This educational program attempts to address these issues by providing state-of-art practice and theory, and promoting information exchange between professionals working in oncology drug development in
1. Overview of oncology drug development in a regulatory environment
2. Cost-effective strategies for late-stage development of oncology drugs
In late-stage oncology drug development, drug developers have to make several critical Go-No Go decisions. Fox example, whether to proceed to the definitive Phase III investigation after a Phase II proof-of-concept (POC) trial, or whether to stop a Phase III confirmatory trial for futility after an interim analysis of the data. How to make the decision rules cost-effective is the primary focus of this course. It discusses the limitation of conventional (subjective and heuristic) decision-making process and introduces modern decision theory from an explicit benefit-cost ratio stand-point of view. The course is intended for decision makers in portfolio management and venture capitalists interested in oncology drug development.
3. Development of oncology drugs with a possible response signature
4. Phase I clinical trials of cytotoxic and cytostatic anti-cancer drugs
Phase I trials are small dose-finding studies designed to rapidly identify the optimal dose of a new agent, which is administered on one or more dosing schedules that were shown to be effective in preclinical models of human cancer. The optimal dose has usually been defined as the maximum tolerated dose (MTD) for conventional cytotoxic anticancer drugs. However, for cytostatic drugs that are relatively specific and selective in terms of their mechanisms of action new paradigm and endpoints (e.g., PK/PD) have to be considered. This short course covers a variety of issues related to Phase I clinical trials with a special focus on cytostatic drugs. Contemporary design options for Phase I clinical trials along with real examples will be discussed in great depth.