ichard Platt, Harvard Pilgrim Health Care and Harvard Medical School

This is a reply to the AHCPR's November 3, 1988, call for ideas and study topics regarding the planned Centers for Education and Research on Therapeutics (CERTs). We write on behalf of the HMO Research Network, a group of health maintenance organizations (HMOs) committed to research in the public domain. These HMOs provide health care for more 10 million members through a variety of commercially and publicly-insured managed care structures covering a wide range of health insurance options. Approximately 200 research faculty are based at these HMOs, with an annual research budget of approximately $100 million. Many of these investigators also have appointments at medical schools and schools of public health, and there are strong collaborations with research universities, schools of pharmacy, and other professional training institutions.

Network HMOs have made substantial contributions to medical and public health knowledge and practice by using their defined populations, information about therapies and outcomes, and ability to intervene at an organizational level to study diseases, treatments, health care delivery, and health care policy. Research portfolios include studies of the epidemiology of disease, of prevention methods, of the efficacy, effectiveness, and safety of therapies (through clinical trials and observational studies), of the impact of educational initiatives directed at both providers and members, of the impact of a wide array of policies regarding health care benefits on individuals, and of reimbursement strategies' effects on providers and institutions.

These HMOs currently conduct considerable research relevant to the proposed CERTs and have an established record of collaboration, which individual HMOs enter into on a case by case basis. One model for such collaboration is the Cancer Research Network, a National Cancer Institute funded 4 year, $17 million cooperative agreement that supports the HMO Research Network's development of research infrastructure and specific research projects. In addition to providing an organizational model, the enhanced research capacity that the Cancer Research Network is creating can serve as the basis for rapid progress in other areas such as those that are the focus of the CERTs. The CERTs will substantially enhance the ability of the HMOs that choose to do so to conduct this type of research by facilitating collaborations on a broad spectrum of research topics related to therapeutics. The ability of HMOs in the Network to use the base that has been created through other funding will substantially reduce the additional investment required the allow the CERTs to make important contributions.

Our experience leads us to make the following recommendations:

• The CERTs goals will be well served if the RFA includes a strong focus on research and education based in large defined populations for which there is demonstrated research competence.
• The organizational structure should include a committed core of investigators who have access to these populations, together with established links to laboratory investigators, schools of pharmacy, and other relevant disciplines.
• It will be essential for the CERTs to secure additional funding from other sources, since the CERTs goals are far too broad to be accomplished within the CERTs resources. In addition, it will be necessary to obtain the support of other agencies, such as FDA, CDC, and NIH that have overlapping interests and responsibilities. Industry support may also be an important funding component, as long as intellectual freedom is preserved.
• Initial areas of emphasis and high priority research topics include:
  1. Understanding biological (including genetic) determinants of drug efficacy.
  2. Assessment of the effectiveness of drug therapy under conditions of actual use.
  3. Assessment of selected drug safety issues—particularly in developing methods for rapid identification and assessment of unexpected serious rare complications of newly marketed drugs, and of studying moderate but important effects of widely used drugs.
  4. Development and evaluation of educational and managerial interventions (including methods to disseminate information) to improve the quality and efficiency of drug use.
  5. Methods to improve compliance with prescribed therapy through exploration of clinical and non-clinical factors associated with compliance.
  6. Assessing the economic and clinical outcomes of cost containment policies. All of these should be applicable both to general populations and to selected populations of special interest, such as the children and elderly.
• Core competencies of CERTs investigators should include epidemiology, clinical pharmacology, behavioral science, health services research, health economics, applied clinical research, population genetics, and education.
• The RFA should focus on development of durable infrastructure and capacity, together with enough substantive research to demonstrate the CERTs ability to accomplish its mandate. The anticipated level of support will allow the recipients to pursue only a small fraction of the important topics that deserve study, and so it will not be possible for CERTs to address the full scope of their mandate until the recipients secure additional funding. An investment in infrastructure and capacity will therefore yield substantially more eventual new knowledge than will support limited to specific research projects.

Thanks in advance for considering these suggestions. The contact author is:

Richard Platt, M.D., M.Sc.
126 Brookline Ave., Suite 200
Boston MA 02215
Telephone: (617) 421-6089
Fax: (617) 859-8112
rplatt@channing.harvard.edu

Richard Platt, Steven Soumerai, Robert Fletcher, Harvard Pilgrim Health Care and Harvard Medical School
Myde Boles, Kaiser Permanente Northwest (Portland)
Arnold Chan, Harvard School of Public Health and Harvard Medical School
Robert Davis, Group Health Cooperative of Puget Sound and University of Washington
Nicole Fehrenbach, Prudential HealthCare
Michael Goodman, HealthPartners (Minneapolis)
Jerry Gurwitz, Fallon Healthcare System and University of Massachusetts Medical School
Marsha Raebel, Kaiser Permanente Rocky Mountain Division and University of Colorado School of Pharmacy
Thomas Roth, Henry Ford Health System
Dennis Tolsma, Kaiser Permanente Georgia

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