November 4, 1998: Deborah Shatin, Center for Health Care Policy and Evaluation
Response to AHRQ on CERTs
Therapeutic Education and Research Centers (TERC)
Given the goal of increasing quality and decreasing cost of health care, AHCPR has designated TERCs as integrated and collaborative education and research centers to address issues in the therapeutic areas of drugs, devices, and biologics (DDB). The cost of therapies, specifically drugs, has increased rapidly in the last several years due to several factors. The availability of ever larger numbers of drugs and direct advertising to consumers and in medical journals has accelerated the number of prescriptions for new drugs, which will be compounded with the aging of the population. Costs include misuse of medications, unintended and iatrogenic consequences of adverse events, polypharmacy and interactions with other therapeutics (drugs, devices, even complementary medicine), errors in administration, compliance and lack of understanding. The TERCs will provide an early warning system of adverse events for new drugs, new indications, and interactions of therapeutics.
Approvals of new therapeutics by the Food and Drug Administration (FDA) are typically based on data from clinical trial studies which may have limited generalizability for the following reasons:
- Limited exposure (numbers in trial only).
- Limited sites/providers (investigative centers rather than general medical community).
- Limited populations (select inclusion and exclusion criteria).
- Limited length of follow-up (generally 6 months at the longest).
- Limited set of questions that focus on that one therapy (rather than combinations of new and/or existing therapies).
To improve quality while reducing costs, the research conducted by the TERCs will be disseminated to inform several different parties, including providers, regulatory decision-makers, policy decision-makers, consumers, health care delivery systems, and insurers.
The following are selection criteria for topics for research or education by the TERCs:
- Prevalent or high cost therapy/condition.
- Upswing in usage, prevalence.
- Controversial usage.
- Preliminary reports of adverse events (MedWatch).
- Issue for government programs (Medicare, Medicaid).
- Relevant to aging cohort.
- New DD or B.
- New combinations of DDB.
- Capacity to disseminate information.
- Comparability of longitudinal, diverse, and large populations.
- Determine access to new technologies/diffusion of innovations.
TERC Requirements and Capabilities: AHCPR/FDA Auspices
____________________________________________________________________________________ Task/Requirement Capabilities Currently Conducted ____________________________________________________________________________________ Research ____________________________________________________________________________________ Improve effective use of DDB Analytic capabilities Practice Guidelines Database access for Professional quick analyses Associations Assess risks Database access (longi- NDA/PMA a. New uses (off-label) tudinal and linked) b. New combinations c. DDB and complementary meds Appropriate use MedWatch a. Compliance Select studies b. Contraindications c. Practice guidelines Comparative effectiveness and Technology Assessment safety Journal lag time Prevent adverse effects Quick turnaround studies MedWatch Ability to quickly query using established dataset ____________________________________________________________________________________ Clinical ____________________________________________________________________________________ Conduct clinical and laboratory Interface with delivery research system: interventions, outcomes, cost-effectiveness Generate new data Linked longitudinal datasets a. Secondary Survey expertise (consumer, b. Primary provider) ____________________________________________________________________________________ Education/dissemination ____________________________________________________________________________________ Clinical information to Access to health plan Internet consumers members, employers, Articles/media physician offices Newsletters Dissemination to providers/ Link to professional Health plan news- health care system societies, letters, Access to health care Professional delivery systems, associations, conferences CDC/AHCPR, Other government agencies Increase awareness of new Both above sets of products capabilities ____________________________________________________________________________________ Administrative ____________________________________________________________________________________ Interorganizational History of cooperative collaboration collaboration Organized committee structure Appropriate parties involved, efficient structure Methodological expertise Research track record Publications ____________________________________________________________________________________
Comparison of EPCs and TERCs
____________________________________________________________________________________ Differences EPC TERC ____________________________________________________________________________________ Meta-analysis of literature Data sources Primary Secondary Select topics Emergent controversies or concerns Consolidation of known information Early warning system New data analysis Professional practitioners and health Additional focus on consumers care organization focus and government Variations in practice patterns Variation in diffusion of new technologies, adverse events Focus on disease or technology Focus on comparative issues Effectiveness and safety DDB combinations New uses ____________________________________________________________________________________ Similarities ____________________________________________________________________________________ Selection criteria specified Interorganizational collaboration Link academia and health care delivery systems ____________________________________________________________________________________
Deborah Shatin, Ph.D.
Director, Research Programs
Center for Health Care Policy and Evaluation
100 Opus Center
9900 Bren Road East
Minnetonka, MN 55343
Telephone: (612) 936-5709
Fax: (612) 936-7270