The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
Here at Cytel, we are engaging in a small celebration this afternoon, as the US House of Representatives has just passed the FDA Reform Bill more generally known as the 21st Century Cures Act.
Although this bill is widely viewed as a reform bill, it will provide extensive funding to both the FDA and NIH to ensure that clinical and pharmaceutical research lives up to its potential to deliver life-saving technologies in a faster, smarter way.
Title II of the act contains approximately 150 pages on drug development. We're sure some of you have read it through and through. However, for those putting off their summer reading until August, here are 4 exciting developments that we want all of our friends and affiliates to be aware:
21st Century Cures (also called Cures2015) is a bipartisan initiative undertaken by the Committee on Energy and Commerce of the US House of Representatives. Amongst the many factors motivating this landmark legislation is the concern that regulatory procedures must keep up to date with innovations in clinical development. Cures2015 aims to reform the regulation of drugs, biologics and medical devices while increasing patient access to safe and effective drugs across therapeutic areas.
21st Century Cures presented a draft bill in January 2015 that would affect several regulatory procedures at agencies like the FDA. Included in the various proposals are reforms to the regulation of adaptive clinical trials and the use of Bayesian methods, and expedited approval processes for breakthrough therapies and medical devices. The landmark legislation also incentives improvements to Phase 2 trial design for certain therapeutic areas.