A QUARTERLY NEWSLETTER FROM THE THOUGHT LEADERS IN COMPARATIVE EFFECTIVENESS RESEARCH
4/1/13 – IN THIS ISSUE – Tune In to Tunis; Coming Soon: Green Park Collaborative – USA; In Print: Hastings Center Report and Genetics in Medicine; On the Podium: Post Approval Summit; At CMTP: Promotions and Introductions; We’re Hiring!
Tune In to Tunis
Welcome to exCERpts, CMTP’s new e-newsletter. In the months ahead, we look forward to giving you a sense of our continuing efforts to make health care more effective and affordable by improving the quality, relevance, and efficiency of clinical research. As you know, CMTP is committed to collaborating with payers and policymakers, life science companies, clinicians and patients to do this work— developing and publishing research standards and other guidance, improving the processes and products critical to clinical research and facilitating consensus around high priority reimbursement and other policies. We hope this newsletter helps keep you up to date.
Recently, we completed a review of our project and broader communications, interviewing people in and around CMTP’s various endeavors and assessing the outreach efforts of more than a dozen peer organizations. We learned that while colleagues may be deeply engaged in a particular CMTP initiative, they rarely hear about other aspects of our work. And while these colleagues are interested in getting more of this information, what they said they really value is our point of view, our unique perspective on what is happening in comparative effectiveness research. As one informant put it, “Don’t just tell me what CMTP is doing; tell me why it matters, in the context of policy, research, and care delivery.”
So that is what we will try to do, not only with this quarterly newsletter, but in our communications with our various networks more broadly. And while we will give you our viewpoint, we also want to hear yours. We hope our perspective prompts further exchange, lending to valuable, actionable insights. Only together, by listening to each other and integrating different approaches, can we move this critically important work forward. We look forward to more conversation.
Sincerely,
Coming Soon
Later this Spring, CMTP will officially kick off the new Green Park Collaborative – USA (GPC-USA), a multi-stakeholder forum that will develop condition-specific study design recommendations to inform coverage and payment decisions in the United States. The GPC-USA will provide a neutral forum within which payers, life sciences companies, patients, clinicians, researchers, regulators and other stakeholders can engage in dialogue regarding methodological standards for studies intended to demonstrate real world effectiveness and value.
The main products of the GPC-USA will be Effectiveness Guidance Documents (EGDs). These present specific recommendations for the design of prospective clinical research that reflects the evidence expectations of payers, informed by the perspectives of patients, clinicians and other decision-makers.
The EGDs developed through this multi-stakeholder collaborative process will provide well-defined study design “benchmarks” that may be useful to:
- Payers making coverage and pricing decisions;
- Medical professional societies developing clinical guidelines;
- Research funding agencies evaluating grant proposals; and
- Organizations producing educational material for patients and consumers.
In 2013, the work of the GPC-USA will focus on methodological standards for clinical development and market access in oncology and diabetes. CMTP will host the first GPC-USA meeting on May 1 in Baltimore, Maryland.
For more information about GPC-USA, including Membership fees and details about the kick-off meeting, please click here and contact Corinne Warren.
In Print
Issues in ethical oversight
While research today is increasingly integrated into healthcare delivery, the kind and extent of ethical oversight required is generally based on whether a project is considered research or practice. Earlier this year, Sean Tunis, MD, MSc, and others published two papers in the Hastings Center Report—one exploring the implications of the current regulatory environment and a second, proposing a new framework where ethical oversight is instead determined, not by the type of work, but rather by possible patient risk and burden. Abstracts to both papers can be found here.
Citations
Kass, N. E., Faden, R. R., Goodman, S. N., Pronovost, P., Tunis, S. and Beauchamp, T. L. (2013), The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight. Hastings Center Report, 43: S4–S15. doi: 10.1002/hast.133
Faden, R. R., Kass, N. E., Goodman, S. N., Pronovost, P., Tunis, S. and Beauchamp, T. L. (2013), An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics. Hastings Center Report, 43: S16–S27. doi: 10.1002/hast.134
Stakeholders and Comparative Effectiveness Research
Comparative effectiveness research on genomic tests is critically important given the rapid pace of genomics innovation. Using an explicit priority-setting framework, Pat Deverka, MD, and others highlight key criteria that stakeholders should consider when prioritizing and deciding among many potential research questions and trial designs in this research area. An abstract for this paper can be found here.
Citations
Esmail, L.C., Roth, J., Rangarao, S., Josh, Carlson, J. , Thariani, R., Ramsey, S.D., Veenstra, D.L., and Deverka, P. (February 2013), Getting our priorities straight: a novel framework for stakeholder-informed prioritization of cancer genomics research. Genetics in Medicine, 15:115-122. doi:10.1038/gim.2012.103
On the Podium
Sean Tunis will have two roles at the May 7 Post Approval Summit, presenting on the “Shifting Role of Pragmatic Clinical Trials in Effectiveness Research and moderating the session: “Panel Presentations: The Need for New and Comprehensive Models for Evidence Development.” For more information about the Summit, please click here.
At CMTP
2013 has been a very exciting year thus far at CMTP. Tania Dutta, MS, MPP, who has worked at CMTP since 2011 as a Research Associate, has been promoted to Project Manager. In addition to her outstanding work for CMTP, Tania traveled to India for her wedding. We congratulate Tania on all of her successes.
CMTP welcomes Nora Osowski, MPH as Research Manager. Nora will be working on various qualitative research projects focused on stakeholder engagement in health policy and clinical management decision-making. Prior to her work with CMTP, Ms. Osowski spent six years at the Institute of Medicine of the National Academies where she contributed to numerous consensus reports for the Board on Population Health and Public Health Practice and the Board on Health Sciences Policy.
We’re Hiring
We are hiring a Senior Research Director, Methods Standards, to oversee of the development of comparative effectiveness research methods standards within GPC-USA, as well as a Senior Program Director to plan, develop, and direct all operations of the GPC-USA. Visit www.cmtpnet.org/careers for additional details and opportunities.