Gene Testing: Future Problem or Just a Blip?
Trial participants are willing to share data to improve their lives and the lives of others, but they also request that data and clinical trial results are shared back to them.
According to data from IQVIA Insights on the oncology pipeline (April 2019), of 15 new active substances launched in 2018, nine featured a predictive biomarker in their trial. Of those nine trials, one approved in non-small cell lung cancer could address over five million patients. The point is that it is a long-held belief, which appears to be bearing out, that as medicine trends toward more personalization, a biomarker of the disease will need to be a part of a patient’s work-up in order to be in a clinical trial and/or receive the approved therapy. In cancer, that could be in the tumor tissue identification, or a blood test, such as the PSA for prostate cancer. But also biomarkers exist for cholesterol and coronary artery disease and further into the genetic testing area.
Many initiatives around using an individual’s lab tests, routine or otherwise, to find an appropriate clinical trial have been introduced in recent years. Somewhat of a holy grail is to match the right patient to the right trial via a biomarker. So when I recently read that 23andMe was
Recent ventures in
There is also the recent announcement from TrialSpark and 23andMe,
Gaining or regaining the trust factor of a large consumer pool that has taken, or is now shying off from taking, a gene or ancestry test because of privacy concerns is a pretty big hurdle for a company dealing with the general public. And as our Managing Editor Michael Christel addressed
Anecdotal information is that trial participants want to share data to improve their lives or the lives of others, but they also want that data shared back to them, as well as final clinical trial results. This will continue to be a space to watch.
Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at
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