PCORI Clinical Data Research Network Funding Opportunity Casts Broad Vision for Clinical Data Use for Research

A couple weeks ago, the Patient-Centered Outcomes Research Institute (PCORI), an organization funded under the Affordable Care Act (ACA), released a funding opportunity to establish a series of Clinical Data Research Networks (CDRNs). The goal for these CDRNs is to develop a data infrastructure that will allow them to provide the data infrastructure for comparative effectiveness research (CER) to be done both within and outside their networks. (A separate announcement for complementary Patient-Powered Research Networks was also made and is included in the PDF announcing funding for the CDRNs.)

Naturally my institution is evaluating whether we have the resources and commitment to apply ourselves, and this gave me a reason to review the funding opportunity announcement in detail. I generated the following summary for my local colleagues, but also can state that no matter what we do, the funding opportunity presents a comprehensive vision for what CDRNs in general should look like, and indeed advances our moving toward the Institute of Medicine (IOM) vision of the learning health system [1].

A total of $56M will be awarded for eight or so $7M projects. Applicants can ask for a higher budget than $7M, but that must be approved by PCORI before a proposal at a higher funding level is submitted. The proposal process will entail two steps, the first of which is the submission of a letter of intent by June 19, 2013. PCORI will then invite some but not all of those submitting a letter of intent to submit full proposals, which will be due by September 27, 2013.

Each CDRN will be required to engage two or more different health systems and have one million or more patients enrolled among them. All systems will be required to have an electronic health record (EHR) system in place and the ability to standardize data among them. In essence, the system must adhere to the data standards specified by Stage 2 of the federal meaningful use program. This includes adoption of standards such as Consolidated Clinical Document Architecture (CCDA) for patient summaries, SNOMED CT for problem lists, RxNorm for electronic prescriptions, ICD-10-CM for diagnoses, ICD-10-PCS for procedures, CMS PQRI 2009 Registry XML Specification for quality reporting, and HL7 Version 2.5.1 for reporting of public health laboratory data and immunization administration. (A succinct overview of these standards in provided in a summary of all of the Stage 2 meaningful use requirements by Metzger and Rhoads [2].)

Another requirement is the ability of the CDRN to identify and recruit cohorts of patients with defined conditions. In particular, three patient cohorts must be able to be identified:

• A disorder of applicant’s choosing that includes 10,000 identified patients
• One or more rare diseases with prevalence less than 1 per 1500 persons in the US
• Overweight or obese patients, identified for presence of diabetes or pre-diabetes

Among the other requirements for the CDRN are:

• Ability to capture complete information on these patients over time, which could be a challenge due to patients getting care in multiple locations that has been shown to be widespread [3, 4]
• Process for patient as well as clinician engagement in governance as well as setting of research priorities.
• Commitment and active involvement of leadership of all participating organizations to play an active role in the governance of the CDRN and its meeting all key objectives
• Willingness to serve as a national data infrastructure resource for the conduct of CER by researchers both within and outside of the network - the award itself does not fund any research but the CDRN must engage CER researchers, including those outside network
• Demonstration of capacity to connect with patients for collecting data and recruiting them into clinical trials
• Capacity to support large CER randomized trials, with the embedding of research activity in functioning healthcare systems while not disrupting their usual healthcare business functions - this will require support of these activities from the respective administrative and executive leadership of participating organizations
• Integrating human subjects oversight, institutional review board (IRB) activities, and informed consent procedures across the network
• Policies to maintain data security, patient privacy, and confidentiality, along with organizational privacy
• Providing access to biological specimens for research purposes
• Robust governance, with the ability to identify and act upon unanticipated problems or issues
• Description of the efficient use of human and other resources to accomplish the project

One additional capacity I would have liked to see required would be participation in informatics and related research looking at the organization and function of the CDRNs and their data collection and usage issues. The development of CDRNs is necessary to advance the learning health system, but it is something for which there are still many unknowns. A research agenda to explore the issues of how to collect and use for research the operational clinical data on a network of multiple healthcare delivery systems and one million patients is critical to make sure our knowledge of how to do this effectively is learned and documented.

References

1. Smith, M, Saunders, R, et al. (2012). Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Washington, DC, National Academies Press.

2. Metzger, J and Rhoads, J (2012). Summary of Key Provisions in Final Rule for Stage 2 HITECH Meaningful Use. Falls Church, VA, Computer Sciences Corp.

3. Bourgeois, FC, Olson, KL, et al. (2010). Patients treated at multiple acute health care facilities: quantifying information fragmentation. Archives of Internal Medicine. 170: 1989-1995.

4. Finnell, JT, Overhage, JM, et al. (2011). All health care is not local: an evaluation of the distribution of emergency department care delivered in Indiana. AMIA Annual Symposium Proceedings, Washington, DC. 409-416.