Patient-centered Outcomes in Research. This section spans approximately 15 pages, in which a need for research in comparative clinical effectiveness is described. On page 610, the law specifies the need to require a new Patient-Centered Outcomes Research Institutes (PCORI) that will be funded by the Patient Centered Outcomes Research Trust Fund (PCORTF). The purpose of this institute is “to assist patients, clinicians, purchasers, policymakers in making informed health decisions by advancing the quality and relevance of the evidence concerning the manner in which diseases, disorders, and other health conditions can effectively, and appropriately be prevented, diagnosed, treated, monitored and managed through research in evidence sent through the system ….” Its duties, described on pages 610–611, include establishing research priorities, establishing research agendas, and issuing contracts for funding and conduct of research. On page 613, the law now requires that this institute “appoint permanent, or ad hoc, expert advisory panels as determined appropriate to assist in identifying research priorities.”
The PCORI must convene certain expert panels relevant to the oversight and management of comparative effectiveness research. One particular expert panel to be administered by the PCORI, described on page 613, is an expert panel for randomized clinical trials. Additionally, page 614 describes a methodology committee, which will have 15 members appointed by the Comptroller General of the United States and will include health care professionals, biostatisticians, and research methodologists. The primary function of the methodology committee is primarily to set methodologic standards for research in comparative effectiveness research.
Page 615 describes a process for evaluating peer-reviewed research. This is a somewhat difficult section to read, but it appears to specify a method by which peer-reviewed research is to be evaluated by agencies of the federal government for establishing funding priority. Although not specified, this would imply that the methodology committee, or perhaps another ad hoc committee, will be created to oversee the peer review process. Interestingly, on page 615, it is specified that the PCORI “may utilize the peer-review process of appropriate medical journals.”
Page 621 describes the training of researchers stating,
The AHRQ in consultation with NIH shall build capacity for comparative clinical effectiveness research by establishing a grant program that provides for training of researchers and methods used to conduct research, including systematic reviews of existing research, and primary research, such as clinical trials. At a minimum, such training shall be in methods that meet the methodological standards …
Underneath this section, which continues on page 622, the law prescribes that the “Secretary of Health and Human Services shall coordinate with federal health programs to build data capacity for comparative effectiveness research, including development and use of clinical registries and health outcomes data networks.”
Interpretation: These pages describe the need for increased comparative effectiveness trials to be conducted in human subjects. No part of this text prescribes any need for increased funding of basic sciences, stem cell research, or any other preclinical area. No mention is made of genomics, molecular medicine, or any other technology development. This is a section that is particularly relevant to research that members of our Society are well-qualified to direct and conduct in emergency care populations. There are several opportunities for service, including the clinical trials and methodology committees. The section on page 621 essentially specifies many of the criteria that are being used by the SAEM Research Fellowship Credentialing Committee.
The funding for these efforts is described on page 623. Again, the PCORI is funded by the PCORTF. For fiscal year 2013, an amount equal to $1 per beneficiary will be committed for funding these initiatives. This funding commitment increases to $2 per beneficiary starting in 2014. The fund will be created in 2010 with a $10 million deposit, with annual funding increasing to $150 million by 2012.