Notice Number: NOT-HL-18-646
Key Dates
Release Date: August 23, 2018
RFA-HL-19-005 , "Management of Asthma in Primary Care- Clinical Center (UG3/UH3 - Clinical Trial Required)"
RFA-HL-19-006, "Management of Asthma in Primary Care - Bioinformatics Group (U24 - Clinical Trial Required)"
Issued by
National Heart, Lung, and Blood Institute (NHLBI)
Purpose
On August 2, 2018, the NHLBI issued Funding Opportunity Announcement RFA-HL-19-005, "Management of Asthma in Primary Care- Clinical Center (UG3/UH3 - Clinical Trial Required). The purpose of this Notice is to clarify that during the UG3 phase of the program, all clinical trials must have started (enrolled at least one subject).
Part 1. Overview Information
Funding Opportunity Purpose
Current language
The purpose of this UG3/UH3 Funding Opportunity Announcement (FOA) is to retrospectively identify and then prospectively compare the best practices being used by primary care providers (PCP) in the United States (US) to manage asthma. The Managing Asthma in Primary Care (MAP) Program will consist of three functional units, including a Primary Care Network (PCN), a Data Management Team (DMT), and a Clinical Consultant Team (CCT). In the UH3 phase of MAP, these units will collaborate to collect data from existing electronic health records (EHRs) using common data elements (CDEs) to capture the characteristics of patients with asthma managed in primary care, their care providers and practice settings, the current management practices (CMPs) or treatment plans used, and the patient outcomes. By the conclusion of the UG3 phase, prospective clinical trials comparing the CMPs that appear most effective in specific patient groups based on the retrospective EHR analysis will be ready to begin. Subsequently in the UH3 phase of the program, the three units will conduct clinical trials to assess those CMPs that were determined to be most effective in specific populations of patients with asthma who are managed in primary care.
Revised language
The purpose of this UG3/UH3 Funding Opportunity Announcement (FOA) is to retrospectively identify and then prospectively compare the best practices being used by primary care providers (PCP) in the United States (US) to manage asthma. The Managing Asthma in Primary Care (MAP) Program will consist of three functional units, including a Primary Care Network (PCN), a Data Management Team (DMT), and a Clinical Consultant Team (CCT). In the UG3 phase of MAP, these units will collaborate to collect data from existing electronic health records (EHRs) using common data elements (CDEs) to capture the characteristics of patients with asthma managed in primary care, their care providers and practice settings, the current management practices (CMPs) or treatment plans used, and the patient outcomes. By the conclusion of the UG3 phase, prospective clinical trials comparing the CMPs that appear most effective in specific patient groups based on the retrospective EHR analysis will have started (begin enrolling subjects). Subsequently in the UH3 phase of the program, the three units will complete the clinical trials to assess those CMPs that were determined to be most effective in specific populations of patients with asthma who are managed in primary care.
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Purpose
Current Language
The purpose of this UG3/UH3 Funding Opportunity Announcement (FOA) is to retrospectively identify and then prospectively compare the best practices being used by primary care providers (PCP) in the United States (US) to manage asthma. The Managing Asthma in Primary Care (MAP) Program will consist of three functional units, including a Primary Care Network (PCN), a Data Management Team (DMT), and a Clinical Consultant Team (CCT).In the UH3 phase, these units will collaborate to collect data from existing electronic health records (EHRs) using common data elements (CDEs) to capture the characteristics of patients with asthma managed in primary care, their care providers and practice settings, the current management practices (CMPs) or treatment plans used, and the patient outcomes. By the conclusion of the UG3 phase, prospective clinical trials comparing the CMPs that appear most effective in specific patient groups based on the retrospective EHR analysis will be ready to begin. Subsequently in the UH3 phase, the three units will conduct the clinical trials to assess those CMPs that were determined to be most effective in specific populations of patients with asthma who are managed in primary care.
Structure
To complete the objectives of the MAP program, three distinct units will collaborate to collect retrospective data and design clinical trials in the UG3 phase, then conduct prospective clinical trials in the UG3 phase.
Phases of Award
The UG3 phase will support the development of asthma CDEs to be collected from the EHRs, a prioritized list of asthma outcomes to be measured, any requisite regulatory approvals [such as Institutional Review Board(IRB)/Data and Safety Monitoring Board (DSMB) approval] prior to the initiation of both the retrospective and prospective clinical trials, retrospective data collection from the EHRs using CDEs, transfer of data to the BIG, and then design of the prospective clinical trials based on the results of the retrospective analysis. Applicants are strongly encouraged to address a comprehensive project management plan that includes consideration of the feasibility of completion of on-time and on-budget performance milestones. All necessary activities needed to allow the prospective clinical trials to be successfully launched with adequate resources at the onset of the UH3 award should completed during the UG3 phase. Enrollment into the prospective clinical trials is expected to begin at the onset of the UH3 award. Subject to NIH funding availability and scientific priorities, UH3 awards will be made after administrative review with particular attention to the extent to which the milestones established for the UG3 phase have been met. If the UH3 is funded, an additional administrative review will be scheduled within the first two years of the UH3 to assess progress toward UH3 milestones, including enrollment milestones and data collection (completeness).
Section IV. Application and Submission Information
PHS 398 Research Plan
Specific Aims
Use the Specific Aims of the UG3 phase to describe how the investigators will achieve the objective of designing prospective clinical trials that include the entire spectrum of asthma patients managed by PCPs in the US, based on the evidence obtained the analysis of retrospective EHR data.
Research Strategy
UG3 Phase Milestones
Revised language
The purpose of this UG3/UH3 Funding Opportunity Announcement (FOA) is to retrospectively identify and then prospectively compare the best practices being used by primary care providers (PCP) in the United States (US) to manage asthma. The Managing Asthma in Primary Care (MAP) Program will consist of three functional units, including a Primary Care Network (PCN), a Data Management Team (DMT), and a Clinical Consultant Team (CCT). In the UG3 phase, these units will collaborate to collect data from existing electronic health records (EHRs) using common data elements (CDEs) to capture the characteristics of patients with asthma managed in primary care, their care providers and practice settings, the current management practices (CMPs) or treatment plans used, and the patient outcomes. By the conclusion of the UG3 phase, prospective clinical trials comparing the CMPs that appear most effective in specific patient groups based on the retrospective EHR analysis will have begun collecting data on enrolled subjects. Subsequently in the UH3 phase, the three units will complete the conduct of the clinical trials to assess those CMPs that were determined to be most effective in specific populations of patients with asthma who are managed in primary care.
Structure
To complete the objectives of the MAP program, three distinct units will collaborate to collect retrospective data and design clinical trials in the UG3 phase, then conduct prospective clinical trials in the UG3 phase.
Phases of Award
The UG3 phase will support the development of asthma CDEs to be collected from the EHRs, a prioritized list of asthma outcomes to be measured, any requisite regulatory approvals [such as Institutional Review Board(IRB)/Data and Safety Monitoring Board (DSMB) approval] prior to the initiation of both the retrospective and prospective clinical trials, retrospective data collection from the EHRs using CDEs, transfer of data to the BIG, and then design of the prospective clinical trials based on the results of the retrospective analysis. Applicants are strongly encouraged to address a comprehensive project management plan that includes consideration of the feasibility of completion of on-time and on-budget performance milestones. All necessary activities needed to allow the prospective clinical trials to be successfully launched during the UG3 phase must be completed. Enrollment into the prospective clinical trials must begin prior to the onset of the UH3 award. Subject to NIH funding availability and scientific priorities, UH3 awards will be made after administrative review with particular attention to the extent to which the milestones established for the UG3 phase have been met. If the UH3 is funded, an additional administrative review will be scheduled within the first two years of the UH3 to assess progress toward UH3 milestones, including enrollment milestones and data collection (completeness).
Section IV. Application and Submission Information
PHS 398 Research Plan
Specific Aims
Use the Specific Aims of the UG3 phase to describe how the investigators will achieve the objective of designing and initiating prospective clinical trials that include the entire spectrum of asthma patients managed by PCPs in the US, based on the evidence obtained the analysis of retrospective EHR data.
Research Strategy
UG3 Phase Milestones
All other aspects of the FOA remain unchanged.
Inquiries
Please direct all inquiries to:
Michelle Freemer, MD, MPH
National Heart, Lung, and Blood Institute/ Division of Lung Diseases
Telephone: 301-435-0202
Email:michelle.freemer@nih.gov