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In order to have new drugs to help with cancers and rare diseases, we have to first try them out in Clinical Trials. The design process of clinical trials is somewhat cumbersome and is often inherently controversial. We want to make sure that the trial gives us the information on safety and effectiveness that we will want to know once it goes on the market. At the same time we don’t want to over-complicate the clinical trial process and take too long to approve drugs that are doing well.
Billy Foster is in a clinical trial and has had a good response to the drug he is taking. Through his involvement with programs through the Kidney Cancer Association (KCA) and the American Association for Cancer Research (AACR) he has become aware of built-in disparities in the design of most clinical trials for cancer related investigations.
Historically, clinical trials in cancer have had little or no participation by people with diabetes or high blood pressure or those from African-American or Hispanic heritage. In the real world, though, once a drug is approved it will in fact be used by a number of people with these additional health challenges and from all racial and ethnic backgrounds. How can we include these variables in the trial design without adding so many variables that the results become difficult to understand is a question that is beginning to be asked.
Billy talks with Mike and Joyce about advocating for clinical trials that work for the participants, the physicians, the pharmaceuticals, and most of all for the people who will use these drugs once they are approved.
