Through patient registries, pharmaceutical companies can obtain real-world effectiveness data about products, including adverse events and outcomes in various patient populations, that go beyond the limited confines of controlled trials.
Postapproval research in one form or another has been around for more than 30 years. Recently the Food and Drug Administration has stepped up its demand on drug developers to conduct more certain, effective, and timely postmarketing studies. While most of these studies fall under mandatory postmarketing commitments (PMCs), some voluntary studies are starting to gain popularity as ways of conducting outcomes research. In particular, pharmaceutical companies are adding patient registries to their postmarketing toolkits.
Traditionally, registries have been used as a way to survey the safety of approved drugs in pregnant women, for example, as well as to observe data from clinical practice. The success of some of the largest disease registries — such as Genentech’s National Registry of Myocardial Infarction (NRMI) — has spurred companies to expand their use.
Industry experts believe that pharmaceutical companies will develop registries as tools to generate real-world data for their products. Already, sponsors are starting to incorporate both scientific and commercial objectives into their postmarketing programs, which is expected to lead to…
Postmarketing Commitments Grow
Experts on this Topic
Peter D. Beitsch, M.D., FACS. Coprincipal Investigator of the American Society of Breast Surgeons’ MammoSite Patient Registry and Director, Dallas Breast Center, Dallas; The American Society of Breast Surgeons was formed to encourage the study of breast surgery, to promote research and development of advanced surgery techniques, and to improve standards of practice for breast surgery. For more information, visit breastsurgeons.org.
Herve Caspard, M.D., Sc.D. Director, Epidemiology, U.S. Health Outcomes/Medical, Sanofi-Synthelabo Inc., New York; Sanofi-Synthelabo is the U.S. affiliate of the global pharmaceutical company Sanofi-Synthelabo, with a focus on cardiovascular disease and thrombosis, diseases of the central nervous system, oncology, and internal medicine. For more information, visit sanofi-synthelabo.us.
Deborah L. Covington, Dr.Ph. Director of Registries and Epidemiology, Inveresk Research Group Inc., Wilmington, N.C.; Inveresk is one of the world’s largest CROs, offering a wide range of product development services to the pharmaceutical, biological, and related industries. For more information, visit inveresk.com.
Richard Gliklich, M.D. President and CEO, Outcome, Cambridge, Mass.; Outcome is a provider of electronic patient registries and postmarketing studies and has managed more than 50 online registries enrolling more than 1 million patients. For more information, visit outcome.com.
Sean Hart, B.S., MBA. CEO, BBCI, Kansas City, Mo.; BBCI is a contract research organization formed in 1976 thatspecializes in designing and managing late-stage drug development (Phase III, IIIB, and IV) programs. For more information, visit bbclinical.com.
Sandy Kweder, M.D. Deputy Director, Office of New Drugs, U.S. Food and Drug Administration, Rockville, Md.; the FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, and cosmetics. For more information, visit fda.gov.
Leanne R. Larson. Senior VP, Patient Registries, Ovation Research Group, Highland Park, Ill.; Ovation Research Group is a health economics and outcomes research and consulting firm that serves pharmaceutical, medical-device, and biotechnology companies around the globe. For more information, visit ovation.org.
Colin Lucas-Mudd. CEO, NCERx LLC, Carlsbad, Calif.; NCERx is a private interactive healthcare publisher dedicated to delivering timely healthcare information to consumers and matching clinical-trial candidates with investigator sites and sponsors. For more information, visit ncerx.com.
Christopher-Paul Milne, DVM, MPH, JD. Assistant Director, Tufts Center for the Study of Drug Development, Boston; The Tufts Center for the Study of Drug Development is an independent, academic, nonprofit research group affiliated with Tufts University. For more information, visit http://csdd.tufts.edu.
Jonathan Morris, M.D. Chairman, CEO, and President, ProSanos Corp., La Jolla, Calif.; ProSanos is a privately held biomedical informatics company that provides data integration and analysis products and consulting services to clients in the pharma and biotech, government/research, and provider sectors. For more information, visit prosanos.com.
Timothy J. Patrick. President and CEO, Proxima Therapeutics Inc., Alpharetta, Ga.; Proxima Therapeutics is a privately held medical-device company that develops and markets innovative radiation delivery systems for the treatment of solid cancerous tumors, with an initial focus on brain and breast cancer. For more information, visit proximatherapeutics.com.
Jeffrey Trotter. President, Ovation Research Group, Highland Park, Ill.; Ovation Research Group is a health economics and outcomes research and consulting firm that serves pharmaceutical, medical device, and biotechnology companies around the globe. For more information, visit ovation.org.
Cyndi Verst-Brasch, Pharm.D. VP, Late Phase, Kendle International Inc., Cincinnati; Kendle is among the world’s leading global clinical-research organizations, delivering clinical-development solutions. For more information, visit kendle.com.
John Walt, MBA. Senior Manager, Global Health Outcomes Strategy & Research, Allergan Inc., Irvine, Calif.; Allergan is a global specialty pharmaceutical company that develops and commercializes products for the eye care, neuromodulator, skin care, and other specialty markets. For more information, visit allergan.com.
Stephen L. Webb. Executive VP, Registrat Inc., Lexington, Ky.; Registrat provides strategic solutions to design and implement registries and peri-approval programs. For more information, visit registrat.com.