Notice Number: NOT-HL-14-028
Release Date: July 2, 2014
Response Date: October 3, 2014 (new date per NOT-HL-14-234; Originally August 29, 2014).
National Heart, Lung, and Blood Institute (NHLBI)
The NHLBI is considering creating a research consortium to evaluate methods for increasing the uptake and application of evidence-based interventions for heart, lung and blood diseases and sleep disorders. This Request for Information (RFI) seeks advice from experts in translating and disseminating evidence-based interventions into clinical practice (T4 Translation) on the design of an effective and practical Research Network that would be "disease agnostic." The objective is to provide an expert infrastructure platform for research on translation related to a variety of diseases and conditions within the mission of the NHLBI. Individuals, institutions and organizations with experience in translation and implementation science and clinical trials networks are invited to submit comments.
Despite significant advances in knowledge on the prevention and treatment of heart, lung and blood diseases and sleep disorders, such interventions are not being implemented to the full extent and do not reach a significant proportion of the US population. By one estimate, adults in the US receive only 55% of recommended care, whether for prevention or treatment of acute or chronic conditions. No mechanism presently exists to expedite the rapid evaluation of methods for improved translation of evidence-based interventions into health care. A concerted effort is needed to reduce the associated morbidity, mortality, public health burden and cost to society resulting from an inadequate application of proven health care interventions. Such an effort will likely require intensive health-care delivery research, including adequately powered randomized trials of multi-level interventions that involve health care providers and patients. It is expected that a T4 Translation Research Network will serve as a platform for studies in different domains and result in a cost-effective generation of knowledge.
To aid in the design of possible future research solicitations the NHLBI asks for comments and suggestions to include, but not limited to, the six key areas described below.
The Institute is interested in determining the most effective infrastructure and organization to conduct T4 translational research in heart, lung and blood diseases and sleep disorders. For the purpose of this solicitation, T4 translation research is defined as research that seeks to study, in a scientifically rigorous way, the best methods to reach clinicians, patients, healthcare systems, and populations to ensure that evidence-based preventive interventions and treatments are delivered effectively and sustained. A consortium allows for coordinated efforts and opportunities to optimize the research translation strategies and organizational structure, while reducing redundancies associated with several separate structures for different diseases. A consortium could include a network of collaborating institutions, such as major medical centers, clinical practice centers, professional organizations, third-party payers, and health management systems in different geographic regions. The NHLBI would like to obtain information regarding the critical elements necessary for an effective consortium and barriers to its implementation. Responses can describe:
1) The organizational structure and overall governance of the Consortium, including what type of institutions or organizations should be included for effective implementation of T4 translational research;
2) How the Consortium would develop, prioritize and implement clinical protocols, including plans for establishing criteria for review and evaluation of potential T4 protocols as well as development and integration of ancillary studies;
3) Optimal methods for managing data from many sites;
4) Issues of informed consent for conducting T4 translational research, including potential issues in IRB clearance;
5) The anticipated personnel and expertise needed for research and administration of such a Consortium and estimated range of related costs; and
6) Other critical elements not outlined above.
Please respond via email to firstname.lastname@example.org. Responses should be identified in the subject line with NOT-HL-14-028 and are due by October 3, 2014 (new date per NOT-HL-14-234; Originally August 29, 2014).
Please direct all inquiries to:
Dr. Peter G. Kaufmann
National Heart Lung and Blood Institute (NHLBI)