Postmarketing studies are becoming increasingly important as regulatory agencies demand more long-term data, which proves efficacy, safety, and quality. But they also are big, expensive, and complicated. Late-phase or registry studies can run for five years or more, compared with the 12 months to 18 months seen for many Phase III trials. This presents significant site and patient retention issues for these longer study durations.
Phase IV studies realized a significant annual growth in complexity as sponsors began collecting more study data to address FDA concerns and differentiate their products, according to a report last year by Tufts Center for the Study of Drug Development.
Experts say responding to the needs of late-phase research requires innovation, enabling technologies, evaluations of cost drivers, and a commitment to achieving data quality through…
Sound bites From the Field
Spencer Goldsmith is President of Harvard Clinical Research Institute, a provider of clinical trial services. For more information, visit hcri.harvard.edu.
Laurie Halloran is CEO of Halloran Consulting Group, a life-sciences consulting firm. For more information, visit hallorancg.com.
Increasing Efficiency of Trials
Featured Thought Leaders:
Steve Albrecht. Global Head, Senior Director, Business Operations, Late Phase, Chiltern International, a global contract research organization with experience conducting and staffing international Phase I to Phase IV clinical trials. For more information, visit chiltern.com.
Peter Aurup, M.D. VP, Head Global Clinical Trial Operations, Merck & Co. Inc., known as MSD outside the United States and Canada; Merck is a global healthcare company providing prescription medicines, vaccines, biologic therapies, and consumer care and animal health products. For more information, visit merck.com.
Ron Christensen, M.D. CEO, Registrat-MAPI North America, a global, late-phase contract clinical research organization to the biopharma and medical device industries. For more information, visit registratmapi.com.
JF Marier, Ph.D. VP and Lead Scientist, North America, Pharsight, a provider of software products and scientific consulting services to pharmaceutical and biotech companies. For more information, visit pharsight.com.
Dave Provost. VP, Post-Approval, INC Research LLC, a therapeutically focused contract research organization. For more information, visit incresearch.com.
Peggy Schrammel. VP, Registries and Post Approval Development, United BioSource Corp., a global scientific and medical affairs organization that partners with life-sciences companies. For more information, visit unitedbiosource.com.
Hani Zaki. Senior VP, PRA International, a global clinical research organization. For more information, visit praintl.com.