Under pressure to develop new medicines more quickly and at lower cost, drug sponsors are looking to answer as many questions as possible in Phase I, including those relating to efficacy as well as safety, according to the Tufts Center for the Study of Drug Development. “The desire to learn more from Phase I studies has led to greater protocol complexity and larger trials, which, with growing regulatory oversight, has helped drive up costs and lengthen timelines, which is just the opposite of what the industry needs to achieve,” said Tufts CSDD Director Kenneth I Kaitin. In addition, developers are increasing their reliance on patient volunteers — now accounting for 38% of all human subjects in Phase I studies — who typically cost more to recruit and retain than healthy volunteers. To help temper, if not reverse, the ever-growing cost of Phase I trials, the research-based drug industry as a whole will likely increase its use of outsourced services and make greater use of biomarkers and diagnostic tests, according Kaitin. Kaitin made his remarks at a meeting of drug industry leaders recently convened by Tufts CSDD to discuss challenges and opportunities in the Phase I landscape. Participants at the meeting, part of Tufts CSDD’s Executive Forum Roundtable Series, noted that: Integrated studies — those with multiple objectives — are likely to grow in popularity, partially in response to financial constraints, especially in smaller organizations. Pressure on drug developers to maximize the amount of information they obtain in Phase I studies will increase pressure on CROs to achieve proof of concept as soon as possible. Public concern over clinical trial safety is likely to keep pressure on sponsors to disclose information about ongoing studies.
