The First 10 Years of CERTs: Yesterday's Tomorrows as Seen Today
The John M. Eisenberg Memorial Lectureship on Therapeutics Research
Retrospective analyses being a key design in pharmacoepidemiology, it is fitting to operate a 'retrospectoscope' on the following series of lectures given by the Centers for Education and Research on Therapeutics (CERTs) between 2003 and 2004 in memory, honor, and acknowledgement of John M. Eisenberg, M.D. and his enormous contributions to health services research and health care. These seven lectures predate notable landmarks in the field of pharmacoepidemiology, including: the withdrawal of Vioxx, the examination of FDA post-marketing safety that it instigated, and the passage of the FDA Amendments Act that brought expanded authorities to FDA as well as continued funding support derived from pharmaceutical company user fees. The landscape of drug use also changed dramatically with the institution of the Medicare drug benefit and the formalization of comparative effectiveness research and dissemination under the Medicare Modernization Act. The introduction and epilogue each frame and enlarge the historical context of the CERTs accomplishments that were celebrated on their 10th anniversary in 2009.
Notwithstanding the many intervening events, the issues and approaches contained in the CERTs Eisenberg Lectures remain evergreen. Therapeutics researchers worldwide are still pursuing solutions and answers to the challenges and questions discussed by the CERTs, who are proud members, contributors, and leaders within this community.
With these lectures and other content found on the CHAIN Web site, the CERTs seek to fulfill their authorizing mandate, which is to conduct state-of-the-art clinical and laboratory research with the explicit purpose of providing objective clinical information to a wide audience that includes consumers, health care practitioners, pharmacy benefit managers, health maintenance and managed health care organizations, health care insurers, and governmental agencies. The larger mandated purpose of CERTs research, education, and outreach activities remains an ambitious target: to improve the quality of health care while reducing its cost, through the appropriate use of drugs, biological products, or devices. By sharing these lectures and other CERTs content on CHAIN, the CERTs aim to enlist you, the reader, as a partner in their charge and efforts.
Anne Trontell, M.D., M.P.H.
Program Director, Centers for Education and Research in Therapeutics
Center for Outcomes and Evidence, Agency for Healthcare Research and Quality
Introduction: The John M. Eisenberg Memorial Lectureship on Therapeutics Research — Robert M. Califf, M.D., M.A.C.C., Leanne K. Madre, J.D., M.H.A., Hugh H. Tilson, M.D., Dr.P.H.
Assessing the Appropriateness, Safety, and Effectiveness of Therapeutics in Defined Populations — Richard Platt, M.D., M.Sc.
Evaluating Programs and Policies to Improve Therapeutics — Wayne A. Ray, Ph.D.
Exploring the Interface Between Medication Safety and Rational Therapeutics: A Report From the Field — William H. Campbell, Ph.D., Kimberly Galt, Pharm.D., Ph.D.
Improving Quality and Equity of Care in Musculoskeletal Disorders — Sharina D. Person, Ph.D., Jeroan J. Allison, M.D., M.S., Robert M. Mayberry, Ph.D., Kenneth G. Saag, M.D., M.Sc.
Preventing the Alignment of the Holes in Swiss Cheese: How Multiple Systems Fail To Prevent Drug-Drug Interactions — Daniel C. Malone, R.Ph., Ph.D., Marietta Anthony, Ph.D., Lane P. Johnson, M.D., M.P.H.
The Clinical Research Enterprise: Configuring the System of the Future — Robert M. Califf, M.D., M.A.C.C.
What Are Our Drugs Truly Doing to Our Patients? Lessons From Pharmacoepidemiology — Brian L. Strom, M.D., M.P.H.
Epilogue: The Eisenberg Legacy, the CERTs Contribution, and a Vision for the Future — Hugh Tilson, M.D., Dr.P.H.