USCACA clinical trial education program

Introduction
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 United States and China.  

 

1.         Overview of oncology drug development in a regulatory environment 

 

This course is designed to cover oncologic clinical trials from Phase I through Phase IV with discussions of relevant design, ethical and regulatory issues, as well as results of complex trials for both cytotoxic and non-cytotoxic agents. Operational and resource issues relating to clinical trial management will be discussed by experts in clinical oncology research. Chemoprevention, novel target therapies, new imaging approaches and an overview of human cancer biology with discussions of specific cancer types, clinical features, and current therapeutics will also be described and discussed. The course is tended for all professionals involved in clinical oncology drug development.

 

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

 

Many new drugs under development in oncology may have greater benefit in, or provide benefit to, a subset of the overall population. The subpopulation of interest may be characterized with a gene expression signature or other biomarker. The evidence for the sub-population effect is generally not conclusive prior to Phase III, leading to risk inherent in studying only the subpopulation in Phase III. However, studying the overall population in Phase III is also risky in that one may miss activity which is present in the subset only. In this course, we will introduce advanced decision methods that address this issue by properly incorporating all prior information available at the decision point. The course is intended for key decision makers in a drug development program.

 

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.