Leadership from NIH, AHRQ, FDA, CMS, NCI, House, Senate, and Academia Discuss the Future of Comparative Effectiveness Research at Friends Forum Supported by Oracle Health Sciences
On June 18, Friends of Cancer Research hosted a forum on the future of comparative effectiveness research (CER). The meeting featured leaders from all sectors to discuss priorities for expanding the conduct of CER in the U.S.
(L-R) Ramsey Baghdadi, Dr. Clancy, Dr. Collins field questions from the audience, Dr. Sigal delivers opening remarks
Discussion with Dr. Collins and Dr. Clancy
The forum began with a discussion between Dr. Francis Collins (Director, NIH) and Dr. Carolyn Clancy (Director, AHRQ) moderated by Ramsey Baghdadi of the RPM Report. Dr. Collins and Dr. Clancy are the first designated members of the seventeen-member Board of Governors of the Patient Centered Outcomes Research Institute (PCORI). This institute, established as a part of health care reform legislation, will play a pioneering role in the future of CER.
During the discussion it was noted that the PCORI Board needs to promote transparency, credibility and inclusiveness in the processes of identifying the best choices for patients.
Dr. Clancy conveyed her optimism about the opportunity to focus research on a longitudinal basis, as well as the legislation’s recognition of the need for additional methods developments. Both agreed that getting meaningful use out of today’s wealth of data is a major priority. This included the importance of establishing a robust infrastructure to support ongoing CER. Specifically, Dr. Collins suggested tapping into patient data gathered in HMOs.
Audience Listens to Panel Discussion
The discussion concluded with a conversation regarding the compatibility of CER and personalized medicine. Both agency directors suggested that the two are complimentary and voiced that CER and personalized medicine ought to be considered “hand in glove.”
Panel 1: Coordination and Use of CER Studies by Federal Health Agencies
The first discussion panel provided the perspective of several key agencies and representatives from Capitol Hill about with the future direction for CER. The panel included the following members:
· Richard Hodes- Director of the National Institute on Aging, (NIH)
· Jesse Goodman- Chief Scientist & Deputy Comm. for Science & Public Health (Acting), (FDA)
· Louis Jacques- Director, Coverage & Analysis Group(CMS)
· Jean Slutsky- Director, Center for Outcomes and Evidence, (AHRQ)
· Stephen Cha- Professional Staff, House Committee on Energy & Commerce
· Andrew Hu- Professional Staff, Senate Committee on Finance
(L-R) Dr. Stephen Cha, Dr. Jesse Goodman, Dr. Richard Hodes, Andrew Hu
The panel opened with enthusiasm for CER and the new Institute, and the inter-agency collaborations that have already begun to take place. Dr. Hodes noted those recently established between the FDA and NIH. The panelists discussed the need for public literacy and transparency in terms of CER, and the importance of filtering CER information through decision makers to improve patient outcomes.
Congressional staff members were asked to discuss the approach they took in developing the health care reform legislation. The two panelists acknowledged that the House and Senate had different visions of the role of CER, although both felt that the language in the bill was structured appropriately. Both panelists made clear that de-linking CER and coverage decisions was a priority. The staffers also agreed that the makeup of advisory committees would be one of the most important factors determining the Board’s success, as well as patient input and participation.
The panelists continued their discussion by suggesting hypothetical CER projects they would like to see undertaken. Dr. Jacques suggested addressing elderly care, and whether particular interventions were as effective if they were administered in-home. Dr. Slutsky spoke of the importance of the CER community to keep an open mind about factors such as different populations, interventions, and the spectrum of care. The panelists also discussed clinical trials in terms of CER, and the challenge of encouraging patients to participate when they frequently would prefer treatment, or in some cases experimental treatment.
The panelists all agreed that research priorities and questions should determine how studies are funded. Dr. Goodman suggested that the range from patient intervention to outcomes, and where breakdowns occur in that range, ought to be considered in this context.
Panel 2: Development of a Linked Health Data Network
The final panel of the CER forum discussed the research potential of health data networks and the processes of effectively capturing productive health data. The panel included the following members:
· Jeff Allen- Executive Director, Friends of Cancer Research
· Bob Croyle- Director, Division of Cancer Control & Population Sciences (NCI)
· Bill Dalton- Director, Moffitt Cancer Center
· Brett Davis- Senior Director, Oracle Health Sciences
· Kim Lyerly- Director, Duke Cancer Center
· Amol Navathe- Medical Officer, U.S. Department of Health and Human Services
(L-R) Brett David, Dr. Kim Lyerly, Dr. Jeff. Allen, Dr. Bill Dalton
The panel began by discussing the importance of current data aggregation efforts. Dr. Croyle spoke of the need for balance among several important elements of the aggregation process: infrastructure development, standards development, and grow-your-own development. One of the biggest challenges facing health data aggregation is the amount of unclear evidence that often faces patients. Dr. Lyerly discussed these issues from a treatment standpoint, suggesting that ineffective data aggregation can lead to over-treating and poor disease management. Dr. Dalton spoke of the need to involve the patient and patient data in this process. He specifically noted that rather than the patient using search engines as a means of understanding their condition and treatment options, there ought to be a data warehouse that is easily accessible and more reliable.
The prospect of establishing a data warehouse led the panel to a discussion on the linking of health data. Brett Davis suggested that the need for upgrades in HIT, as well as information liquidity, must be addressed before adequate data linking can occur. Dr. Allen spoke of the government’s role as a convening entity that must be sensitive to the needs of agencies and patients. Dr. Navathe described these activities as a priority for government, as well as the balance of long-term and short-term visions and goals.
The panelists agreed that the marriage of different types of data – such as patient-reported outcomes and claims data – was instrumental in making data more useful. The need to encourage active engagement amongst patients, especially in minority communities was highlighted. Coupled with a growing mistrust in the government and the Internet is an increasing trust in physicians. Dr. Navathe felt that government was aware of this issue, and HHS has already begun making investments to address this. The panel concluded with the consensus that the development of an effective data network is the necessary future of health information. Upgrades and investment in HIT, as well as data collection from a grassroots level, will be required to realize these opportunities.
A complete conference report will be prepared in the coming weeks.