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Change and Opportunity in the Phase I Landscape –
January 2009; Vol. 4 No. 1
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. 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.
“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.”
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