FasterCures Comments on the Federal Coordinating Council for Comparative Effectiveness Research Draft Prioritization Criteria and Strategic Framework

FasterCures submitted the below comments on the prioritization criteria and strategic framework developed by the Federal Coordinating Council for Comparative Effectiveness Research.
________________________________
June 10, 2009

To: Federal Coordinating Council for Comparative Effectiveness Research

From: Margaret Anderson, Chief Operating Officer, FasterCures

Re: Draft Prioritization Criteria and Strategic Framework

Submitted Electronically: http://www.hhs.gov/recovery/programs/cer/draftdefinition.html

Thank you for the opportunity to comment on the Council's Draft Prioritization Criteria and Strategic Framework. They are both very concise and thoughtful documents with which we substantially concur. We did, however, want to highlight some issues which we don't feel are directly addressed that may inform your thinking going forward.

• In addition to informing better point-of-care decisions by patients and providers, building the evidence base through comparative effectiveness research can elucidate critical clinical research questions deserving investigation, which will accelerate the development of new and improved diagnostics and therapeutics. If that can be reflected in the prioritization criteria in some way (perhaps under #5, "potential for multiplicative effect"), we believe that would be of great value.
• We are pleased that the Strategic Framework addresses not only the research studies themselves, but also the human and scientific capital necessary to execute the research -- including, very importantly, developing methodologies needed to conduct the research efficiently and effectively. We urge you to give this issue the attention it requires. The scientific underpinnings of comparative effectiveness research are still being developed, and it will be important to monitor the progress of the field as early studies funded through ARRA yield results.
• Also addressed in the Strategic Framework is the data infrastructure supporting CER, another area we hope will be given careful attention. In particular, we hope the Council will make an effort to ensure that investments in health information technology being advanced separately with ARRA funds are supportive of the requirements for conducting CER to the greatest extent possible.
• We are also pleased to see recognition of the fact that translation, dissemination, and adoption of the results of CER are as important as the studies themselves and hope that funding will be devoted to pursuing this critical goal.
• We hope and expect that the vision driving federal spending on CER will continue to be enhancing and customizing care for patients, and that it will not be used to limit access to or availability of effective treatments on an individualized basis.

FasterCures' mission is to identify ways to accelerate the discovery and development of new therapies for the treatment of deadly and debilitating diseases both in the United States and around the globe. The organization was founded in 2003 under the auspices of the Milken Institute to aggressively catalyze systemic change in cure research and to make the complex machinery that drives breakthroughs in medicine work for all of us faster and more efficiently. FasterCures is independent and non-partisan. We do not accept funding from companies that develop pharmaceuticals, biotechnology drugs, or therapeutic medical devices. Our primary mission is to improve the lives of patients by improving the research environment, research resources, and research organizations.