By Jill Johnston, WCG Clinical and Tricia See, ScM, CGC, InformedDNA
Researchers today better understand the heritability of neurological and psychiatric disease, although there is still so much more to learn. Through advances in genetics and genomics, they are making tremendous progress in identifying the genes and gene variants involved in neurodegeneration. As a result, genetic testing is making it easier to identify patients for clinical trials.
However, genetic testing in the context of clinical trials raises raise important ethical issues, including ones related to informed consent and disclosure of results. As is often the case with technology, the science may be outpacing our understanding of the broader implications. In fact, such concerns have spawned a relatively new field of study—neurogenethics.
In addition, myriad operational concerns exist for sponsors and sites; they range from finding patients to test and identifying which genes and mutations to test for, to designing appropriate protocols and managing the resulting data and results.