Several recent analyses of clinical trial endpoints for cancer indicate that clinical trial research may be overly focused on statistical benefit. The result is that new therapies can be approved more easily; yet the therapies may only buy patients a few months of overall survival (OS) time. On the flip side, what happens to therapies that have shown clinical benefit but may suffer from poor statistical trial design?
Brad Thompson, CEO of Oncolytics Biotech, suggests that given the novel therapies that are showing promise (e.g., immunotherapy, oncolytic viral therapy), there ought to be an openness and understanding of a wider range of acceptable trial endpoints. For example, Dr. Thompson says that nontraditional endpoints, such as response rate (RR), could be particularly valuable in immunotherapy studies. “A focus on RR would allow drug developers to prove that immunotherapies mechanically do what they are supposed to do: kill tumors,” says Dr. Thompson. “Progression-free survival (PFS) is not directly related to OS in any context involving the immune system, including the development of new immunotherapies. To use PFS as an endpoint is neither scientifically nor technically warranted.”
More About Dr. Brad ThompsonA co-founder of Oncolytics Biotech, Dr. Thompson has held the positions of Executive Chairman of the Board, President and Chief Executive Officer since April 1999. He has provided leadership to various organizations within the biotechnology sector for more than 20 years. Prior to his role with Oncolytics, Dr. Thompson was the Chief Executive Officer of SYNSORB Biotech from 1994 to 1999. From 1983 to 1994, Dr. Thompson worked in a senior role at the Alberta Research Council. He is a current member and Emeritus Chairman of BIOTECanada and sits on the boards of various other biotechnology companies. He received his PhD from the University of Western Ontario in the Department of Microbiology and Immunology.
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