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February 17, 2012
Patient-Centered Outcomes Research Institute
1701 Pennsylvania Ave. NW
Washington, DC 20006
Re: Draft National Priorities for Research and Research Agenda, Version I
The Association of Clinical Research Organizations (ACRO) represents the world's leading clinical research organizations (CROs). Our member companies provide a wide range of specialized services across the entire spectrum of development for new drugs, biologics and medical devices, from pre-clinical, proof of concept and first-in-man studies through post-approval and comparative effectiveness research. With more than 75,000 employees engaged in research activities around the world, ACRO advances clinical outsourcing to improve the quality, efficiency and safety of biomedical research. Each year, ACRO member companies conduct more than 11,000 clinical trials involving nearly two million research participants in 115 countries.
With this broad and unique perspective on research, ACRO welcomes this opportunity to comment on PCORI’s Draft National Priorities for Research and Research Agenda.
We will focus our comments on the fifth priority, “Accelerating Patient Centered and Methodological Research.” Clearly it is within PCORI’s mission to investigate patient-centered research methodologies that will ultimately have the most impact to improve healthcare.
That said, ACRO is concerned that this “research on research” may not represent the best use of PCORI’s resources.
We are especially troubled by one area in particular, the notion that PCORI needs to invest in expanding the PCOR workforce, building research networks and accelerating infrastructure. If by infrastructure, PCORI means developing registries or interoperable data networks to share information for research analysis, then ACRO would be supportive of these limited efforts.
But the statement that “The Nation’s capacity to conduct patient-centered CER quickly and efficiently remains extremely limited” is simply not true. In fact, we would argue that the existing capacity to conduct patient-centered CER is virtually unlimited if PCORI considers the availability of CROs, other healthcare research and consulting organizations and some of the top-level academic research centers.
Much as PCORI has pledged to avoid redundancy and coordinate efforts with other entities that conduct CER, like AHRQ and the NIH, we strongly encourage PCORI to use the plentiful, highly-qualified research resources that currently exist to achieve its goals. There is simply no need to recreate the skilled workforce and vibrant networks that currently exist in the private sector and some areas of academia.
We note that this priority area is targeted to receive 20 percent of PCORI’s funding over the next 10 years, or approximately $600 million. ACRO maintains that these funds would be much better allocated to conducting actual PCOR that may lead to improved health outcomes or delivery system improvements than activities around training or infrastructure development.
On a separate matter, ACRO is compelled to comment on PCORI’s consideration of funding investigator initiated research. We strenuously object to this direction and believe it violates PCORI’s statutory mandate to “identify national priorities” and “to establish and update a research project agenda.” There is simply no room for PCORI to be subject to the whim of an individual investigator where this interest does not align with the overall national priorities for PCOR. Rather, PCORI must establish a clear research agenda, request proposals to conduct the identified research projects, and award contracts to those entities best qualified to deliver high-quality results in a timely and efficient manner.
Thank you for the opportunity to comment. We look forward to engaging in ongoing dialog with PCORI.
John J. Lewis
Vice President of Public AffairsDownload as PDF