How to Better Establish Clinical Utility for Tests in Personalized Medicine
It’s very important to take all of these research developments, finding new changes in the DNA, and actually show that they are benefiting patients’ so?called clinical utility. These are useful findings in the clinic.
You need to go that one step, from finding a new mutation in DNA, to showing that this does, in fact, help patients, but the paradigm is changing. Each patient can have a somewhat different profile of their tumor, so to do a study that lumps together patients of different profiles can be difficult.
We’re coming to grips with that now. There are designs?new studies are being instituted all the time?that take that into account. Already we have many case reports of drugs working against the profiles of particular patients.
What we have to do now?we’re in the midst of doing several studies like this?is to make those findings as generalizable as possible. For example, if we find an alteration that has never been seen before, we can be fairly certain that a drug will, in fact, work against that new alteration, based on the mechanism and the biology.