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IOM Envisioning a Transformed Clinical Trials Enterprise in the United States

Peter Paul Yu, MD, FASCO

10 Nov 2011 1:32 AM

This week the Institute of Medicine held a workshop on “Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020.” During the 2-day meeting a variety of underlying themes were presented, none more transformative than that presented by Robert Califf, Vice Chancellor for Clinical Research, Duke University and Editor-in-Chief of the American Heart Journal. Dr. Califf posed that a central flaw in the United States clinical trials enterprise (CTE) is that we have allowed the health care delivery system to evolve distinct from the CTE. Today, the two largely function independent of each other. I would suggest that this is the result of yet another split, between academic and community medicine. Although the benefits of NCI programs such as the Cooperative Groups and CCOPs, combined with the unique history of oncology and its dependence on pharmacologic-based research have mitigated the negative impact upon oncology compared with other fields of medicine, we have not escaped from this untouched. The untoward consequences of this dichotomy include:

  1. Patients and providers perceive clinical research as "optional," experimental and in a less favorable light than standard care options, not withstanding the often very limited benefits of standard therapies.

  2. The goals of clinical trials often reflect the interests of the academic-based researcher rather than the interests of patients and community oncologists, resulting in complex, multi-arm trials with several internal randomization steps that are hard to explain and understand. Fifty percent of clinical trials that are opened never accrue a single patient and across medicine, 85% of trials are considered failures.

  3. Insurers do not routinely cover clinical research costs, since research trials are considered to be distinct from routine care instead of being built into the reimbursement system.

  4. Construction of costly, redundant and parallel systems for operational functions such as billing, contracting and medical record documentation.

  5. The loss of a quality improvement benefit that results from conducting clinical trials with their required attention to detail and audits where unrecognized system errors can be identified.

  6. Clinical trial protocols often seemed designed to generate audit problems, since the protocol procedures often deviate significantly from routine care workflows.

  7. The lack of commitment to research across the spectrum of medicine negatively impacts the conduct of research. Imaging comes to mind.

  8. By segregating the CTE from routine care, patient selection bias is introduced, which is one reason for the need for clinical effectiveness research.

  9. The adoption of clinical trial findings into routine clinical practice is slowed by a supply side process wherein the findings are pushed out to clinical practice instead of a demand side process with greater involvement by patients and providers in designing clinical trial questions so that the results are pulled in by the end users of that knowledge.

A potential path towards convergence of the CTE and health care delivery systems may be the Meaningful Use (MU) program. The federal government has made it quite clear what it considers the primary goals of the nation’s health care delivery system should be: the five overarching goals delineated by the IOM and adopted by ONC for MU. Conspicuously, supporting the CTE is not one of those goals. The message is clear; the CTE must cast itself as part of the MU objectives or else continue to remain apart, with all of the negative consequences outlined above. Research by itself is not a goal. The value of research in the real world is as a mechanism to achieving improved health and economic outcomes.

Reform of the United States health care delivery system is upon us and presents an unprecedented opportunity to recast the CTE as a vital and sustainable part of a new health care delivery system. To do otherwise is to condemn our future to our past.

Posted in: Research

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Peter Paul Yu, MD, FASCO