US lawmakers to introduce bill to speed up clinical trials — CNBC
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US lawmakers are preparing to introduce the Faster Clinical Trials Act, aiming to establish clinical networks and ease patient access to trials.
Democratic Congressman Jake Auchincloss and Republican Congressman Morgan Griffith plan to introduce the bipartisan Faster Clinical Trials Act in the United States. The document is intended to make it easier for patients to participate in clinical trials and reduce the time needed to launch them, CNBC reports.
Network of research sites
The initiative provides for the creation of a network of clinical sites that could be reused for studies of specific diseases or types of treatment. The bill is also intended to encourage drug manufacturers to use computer modeling at early stages of development and address common reasons why the US Food and Drug Administration suspends clinical studies.
The document proposes expanding trials at the point of care. Under this approach, patients could receive experimental drugs from their regular doctor instead of traveling to a specialized research center. Researchers could monitor their condition through video communication, electronic medical records, or wearable devices.
Griffith said this approach could also be useful for patients with chronic illnesses, including black lung disease. According to him, some residents of his district in southwestern Virginia have to spend two hours or more traveling to medical centers conducting research.
Funding and the FDA's role
The bill provides for the creation of a Center for Clinical Trial Innovation within the FDA, which will coordinate networks of research sites. It also defines tasks for the FDA's Rare Disease Innovation Hub, including enabling it to advise drug manufacturers on their problems and assist agency teams that evaluate drugs.
The initiative provides up to $75 million in annual funding for the FDA over five years. Trial networks are to prioritize rare and chronic diseases. The goal of the document is to reduce research costs and participant recruitment time by at least 30%.
Intensive treatments, including gene therapy, will still have to be administered at academic medical centers, said Mark McClellan of the Duke-Margolis Institute for Health Policy. At the same time, patients could potentially be monitored remotely at home after procedures. Griffith expects the House of Representatives to consider the bill no earlier than next year.
