Stakeholders want streamlined clinical trials

Stakeholders discussed ways to make the drug development process more efficient for patients during a Friday hearing held as part of the U.S. House of Representatives Energy and Commerce Committee's 21st Century Cures initiative. The National Organization for Rare Disorders called for a "significant" reform of the institutional review board system for assessing new therapies. According to NORD, the process of receiving IRB approval, which is required for any changes to study design and typically requires individual approvals from each institution's IRB, is one of the greatest impediments and costs to all clinical trials. The organization recommended that Congress develop legislation to create a system that is portable across institutions.

Pat Furlong, president and CEO of the not-for-profit advocacy group Parent Project Muscular Dystrophy (PPMD), also called for greater flexibility in clinical trials, recommending that post-hoc or post-trial analysis be used to gather information on benefits and risks without making for "unnecessarily lengthy and burdensome trials." ...