Clinical Data Research Networks (CDRN): Improving Infrastructure for Conducting Patient-Centered Outcomes Research (PCOR)

CLOSED

Letter of Intent Deadline:

June 19, 2013 at 5:00 p.m. ET

Summary:

The goal of PCORI’s National Patient-Centered Clinical Research Network Program is to improve the nation’s capacity to conduct comparative effectiveness research (CER) efficiently, by creating a large, highly representative electronic data infrastructure for conducting clinical outcomes research. Specifically, this program will promote a more comprehensive, complete, longitudinal data infrastructure; broader participation of patients, clinicians, health systems, and payers in the research process; and improvements in analytic methods for both observational and experimental CER. Through this funding announcement, PCORI seeks to support new or existing Clinical Data Research Networks (CDRN) that will develop the capacity to conduct randomized comparative effectiveness studies using data from clinical practice in a large, defined population.

Funding Announcement:

The National Patient-Centered Clinical Research Network: Clinical Data Research Networks (CDRN)—Phase One

*Key Dates:

Online System Opens

May 15, 2013

Letter of Intent (LOI) Due

June 19, 2013

Applicant Town Hall Session

Sept. 3, 2013 at 2:30 PM ET

Register Here

Application Deadline

September 27, 2013

Merit Review Dates

October-November 2013

Awards Announced

December 2013

Earliest Start Date

January 2014

Maximum Budget:

$7 Million total costs/project

Maximum Project Period:

18 Months

Funds Available Up To:

$56 Million

Eligibility:

Applications may be submitted by:

Established or newly developed networks that involve two or more healthcare systems, with plans to function as integrated research network, such as:

  • Two integrated healthcare delivery systems
  • A healthcare delivery system and one or more health plans
  • A health plan and two or more delivery systems
  • A pratice-based research network and a health plan
  • An accountable care organization and its affiliates

 Additional information can be found in the full announcement.

All US applicant organizations must be recognized by the Internal Revenue Service. Foreign organizations and nondomestic components of organizations based in the United States may apply, as long as there is demonstrable benefit to the US healthcare system, and US efforts in the area of patient-centered research can be clearly shown. Organizations may submit multiple applications for funding. Individuals may not apply.

Review Criteria:
Applicants do not need to have all these in place at the application stage.

1. Description of the network, its component systems, the available data from each system, and the network’s potential for demonstrating coverage of a diverse, representative population of at least one million persons by the end of the 18-month award period.

2. Current informatics standards, interoperability between systems, and plans for achieving data standardization and interoperability between systems within network and across CDRNs.

3. Capture of complete, comprehensive clinical information over time.

4. Demonstrated ability to engage and mobilize patients and clinicians to participate in network governance and use, including generation of research questions.

5. Involvement of systems leadership in the application and in plans for governance and use of the resource.

6. Plans and/or ability to identify and recruit cohorts of patients with defined conditions.

7. Willingness to serve as a national data infrastructure resource for the conduct of CER by researchers outside, as well as within, the network.

8. The ability to efficiently contact patients within the covered population for the purposes of collecting patient-reported information and for efficient recruitment to clinical trials.

9. Capacity to support large-scale comparative effectiveness randomized trials, and to embed research activity within functioning healthcare systems without disrupting the business of providing healthcare, coupled with evidence of support for these activities from administrative and executive leadership.

10. Alignment of human subjects oversight, IRB review and approval, and informed consent procedures with the level of risk in proposed comparative effectiveness studies.

11. Clear, thoroughly described and proven policies to maintain data security, patient privacy, and confidentiality, as well as organizational privacy.

12. Ability to collect, store, retrieve, process and/or ship biological specimens for research purposes.

13. Centralized monitoring for review of progress with ongoing studies to identify and address unanticipated problems or issues.

14. Clear description of the efficient use of human and other resources to accomplish the work.

Applicant Resources

Application Guidelines and Review Criteria

Other:

*Deadlines are at 5:00 PM ET. If deadlines fall on a weekend or a federal holiday, the deadline will be the following Monday or the next day after the federal holiday.

To propose a project budget that is greater than the direct costs or maximum project period listed for a PFA, submit a request by the LOI deadline using the templates provided above.