December 26, 2017

Drug Industry Daily quotes Todd Halpern on trends in clinical trials

1 min

Todd Halpern was quoted in an article about clinical trials' use of real-world evidence on December 26, 2017, in Drug Industry Daily. Mr. Halpern referenced the 21st Century Cures Act as a major influence on clinical trial trends for 2018 and notes the FDA's three guidances issued in December that alter which digital health products are considered FDA-regulated devices under the law. The guidances clarify that certain digital health technologies, such as clinical administrative support software, fall outside the agency's purview.

In remarks to the reporter, Halpern added, "That's very quick action by the FDA and it shows a clear focus in this space, and I think that is going to have some ramifications in the trials space with regard to trials designed to support approval of diagnostic digital tests and also use of digital products in support of clinical trials for pharmaceuticals. Efforts by the agency and Gottlieb to speedily implement the law 'show an intense focus that is probably reflective of not just FDA leadership's priorities but also what the FDA is seeing from industry.'"