BIO Public Statement: National Patient and Stakeholder Dialogue
Thank you for the opportunity to present comments on behalf of the Biotechnology Industry Organization, which supports PCORI's goal of increasing the availability of accurate, scientific evidence to inform clinical decision-making. BIO members are involved in the research and development of novel interventions to prevent, treat, and cure diseases through the most advanced science.
While BIO appreciates PCORI's continual efforts in securing input from a variety of interested stakeholders, we are concerned that the Institute's decision to release its National Priorities and Research Agenda simultaneously rather than sequentially discourages meaningful input on both documents and disrupts the iterative development of the Institute's priorities that was envisioned under statute. In the future, PCORI should avoid soliciting comments on new documents while other comment processes are ongoing. PCORI has not yet finalized the definition of Patient Centered Outcomes Research, which itself is fundamental to informing the work within the National Priorities and Research Agenda. Additionally, BIO urges PCORI to adopt a systematic process in producing final policies which include a discussion of and generalized responses to stakeholder comments which will inform the stakeholder community of the Institute's point of view and rationale for choosing, or not, various options. All comments PCORI receives should be posted on its website. Transparency and meaningful stakeholder involvement are critical to maintaining PCORI's credibility.
BIO believes that PCORI has a unique opportunity to distinguish itself from existing bodies in clinical comparative effectiveness, for example, in identifying areas of healthcare delivery that can be improved. However, we are concerned that by proposing a research agenda that lacks specificity, PCORI risks ceding its authority to the researchers applying for funding. The draft document gives no indication as to how PCORI will prioritize within the research areas it has proposed. Recent comments from Dr. Selby indicate that PCORI plans to identify more specific “areas of priority funding,” as part of future iterations of the Research Agenda. To the extent that these areas are identified in a more specific manner than they have been for this first draft, BIO urges PCORI to solicit stakeholder feedback on each topic through an open comment period.
Finally, the lack of specificity in describing the research priorities make PCORI’s proposed funding allocations extremely hard to evaluate. For instance, PCORI has allocated the bulk of its funding to support research in the area of “Assessment of Options for Prevention, Diagnosis, and Treatment” without describing the rationale for that prioritization. We urge PCORI to re-examine its allocation determinations. PCORI has a real opportunity to distinguish itself from existing CER entities by focusing on ways to improve health systems and delivery - an area with significant gaps in research and information. Yet, PCORI proposes to allocate just 20 percent of funding to "improving healthcare systems" by researching topics such as "coordinating care for complex conditions" and "comparing health system-level approaches to improving access." Poor care coordination -- inaccurate or incomplete transfer of information, lack of appropriate follow-up, and poor communication -- results in preventable hospital readmissions and increased emergency department visits. More information is needed on best practices to achieve better care coordination and in turn, improve patient outcomes. Therefore, BIO recommends that PCORI increase funding for research into improving healthcare systems to fill this much needed void. We appreciate the opportunity to share our feedback with PCORI and look forward to submitting our comment letter by the March 15 deadline.