November 4, 1998: Deborah Shatin, Center for Health Care Policy and Evaluation

Response to AHRQ on CERTs

Responses received to a call for ideas and study topics for implementation of AHRQ's new demonstration program for grants to establish Centers for Education and Research on Therapeutics (CERTs).

Therapeutic Education and Research Centers (TERC)

Background/Scope

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.

Selection Criteria

The following are selection criteria for topics for research or education by the TERCs:

  1. Prevalent or high cost therapy/condition.
  2. Upswing in usage, prevalence.
  3. Controversial usage.
  4. Preliminary reports of adverse events (MedWatch).
  5. Issue for government programs (Medicare, Medicaid).
  6. Relevant to aging cohort.
  7. New DD or B.
  8. New combinations of DDB.
  9. Capacity to disseminate information.
  10. Comparability of longitudinal, diverse, and large populations.
  11. 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
MN008-W109
100 Opus Center
9900 Bren Road East
Minnetonka, MN 55343
Telephone: (612) 936-5709
Fax: (612) 936-7270

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Current as of October 2012
Internet Citation: November 4, 1998: Deborah Shatin, Center for Health Care Policy and Evaluation: Response to AHRQ on CERTs. October 2012. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/policy/foia/certs/cert4.html