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Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary
studies. This registry would help ensure that studies are being conducted with prospectively written protocols and that negative results come to light.
It was further suggested that the roundtable engage major journal editors and urge them to pay more attention to tumor marker studies with regard to design, quality, and transparency.
Participants discussed the need for a public education effort regarding genomic interventions. Terry said that many people believe the FDA to be primarily interested in the public’s health and not in commerce and assume that agency clearance implies that the product is beneficial and should be adopted. On the other hand, a participant noted, the public often perceives FDA as being too slow or hindering access to products (such as happened with products targeting the human immunodeficiency virus). Another participant added that the current environment is one of “immediate-communications” and that health literacy and public understanding about evidence are highly variable. While eager for new products to be available on the market, the public in general does not demand evidence to support claims about new interventions. As a participant said, “If we could simply educate the public to ask [for evidence] every time they hear a claim, I think it would help us.” It was also noted that whole-genome analysis will enable providers to give patients their entire genome, but it will not be of much practical use unless the genome can be related to various kinds of clinical evidence.