RFA-AR-19-027: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center (U24 Clinical Trial Not Allowed)
Internal Deadline: Contact the Office of Research if interested.
LOI: February 20, 2019
External Deadline: March 20, 2019, 5pm PT
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: 1 – 2
Anticipated Amount: up to $6 million
Cost Sharing: For grantees from a for-profit organization, this FOA does require cost sharing, as defined in the NIH Grants Policy Statement. More information on cost matching requirements is in Section IV.2 R&R or Modular Budget
Submission Process: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants
Materials to submit:
- Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
- CV – (5 pages maximum)
Who May Serve as PI: Standard NIH eligibility requirements.
The BACPAC Research Program consists of four primary components that will work collaboratively to achieve the overarching goals. This call refers to a Data Integration, Algorithm Development and Operations Management Center (DAC). This Center will guide and coordinate all activities of the consortium and ensure communications, interactions, synergies and accountability. It will manage a core as a Consortium-wide registry, including patient reported outcomes and preferences. The DAC will include the BACPAC Systems Biology and Bioinformatics Group (SBG) to provide system level analysis for BACPAC generated multidimensional datasets to produce an integrated model of LBP. Using data from clinical studies across the Consortium, this Center will develop patient-centered algorithms for prediction of optimized therapeutic interventions.
Areas of responsibility include:
- Clinical Registry, Data Integration and Coordination
Areas of responsibility include:
- Providing scientific and operational support to the CMC during the development of the BACPAC Consensus Plan for case definition, minimal dataset, and outcomes measures
- Providing the necessary operational, material and training support to the clinical sites to facilitate the adoption of the consensus plan for uniform collection of common data elements.
- Establishment and maintenance of a secure, efficient, and easily accessible electronic database for storage and interrogation of clinical study data. It is anticipated that data will include demographics, medical history, medications, results of clinical laboratory tests, findings from physical examination and other diagnostic procedures, and responses to questionnaires and patient-centric diaries.
- Development of a flexible approach, in collaboration with the DAC SBG, to support the integration of mechanistic data with clinical datasets. The first level of integrative analysis of research data generated from the mechanistic studies will be carried out by the ICs in the MRCs.
- Development and Implementation of standard operating procedures for data curation, quality control and quality assurance of data entry to facilitate downstream data integration and algorithm development.
- Monitoring and evaluation of protocol execution, subject accrual, data quality received from the CCs, and provide relevant reports to the SC, DSMB and NIH.
- Initiation of changes in training/procedures in response to issues/protocol changes that emerge during trials.
- Managing a central IRB for the BACPAC Consortium Research Program
- Preparation of datasets for deposition into public data repository for broad sharing.
- Algorithm Development, Testing and Validation
The DAC will conduct de novo modeling, using systems and machine learning approaches to improve current diagnostic and treatment algorithms. Areas of responsibility include:
- Generation of improved and new algorithms to incorporate new phenotypic data obtained by the research sites in the clinical cohorts.
- Utilization of real-time information from clinical and biologic data generated from the BACPAC Research program to model new algorithms to project treatment responses. These data will be used to inform SC evaluation and recommendation of protocol modifications about specific phenotypes, biomarkers, and/or interventions that may need to be added or eliminated for successful execution of the protocol.
- Working with the DAC Clinical Registry, Data Integration and Coordination group and the Systems Biology and Bioinformatics group to integrate clinical and mechanistic data.
- Working with the DAC Clinical Registry, Data Integration and Coordination group, the MRC Clinical Cores and the CMC to conduct testing and validation of new algorithms.
- Operations Management
Areas of responsibility include:
- Providing support to the SC, the EC, the CMC and Functional Working Groups including planning and arranging meetings for the various committees and groups.
- Oversight of the budget for the BACPAC Collaborative Research Project and Ancillary and Pilot Projects.
- Administration of the EPPIC-Net fees and negotiation of clinical agreements and budgets with the EPPIC-Net and PIs for the Phase 2CTs.
- Establishing and maintaining effective communications across BACPAC to ensure the members of the consortium understand their roles and responsibilities, adhere to the SC approved policies and procedures, and are kept abreast of the scientific and procedural development in the Research program.
- Development and maintenance of a secure portal for the distribution of study documents, forms, and information, including metrics (textual and graphical) of study progress and performance (e.g., expected versus actual subject accrual indexed by the CCs) across the BACPAC components.
- Development and maintenance of an open-access web site to provide information about BACPAC to the public and prospective research subjects. The public web site must comply with all applicable Federal regulations, including Section 508 of the Rehabilitation Act of 1973 (29 USC 794d). See http://www.section508.gov and http://www.nih.gov/icd/od/ocpl/resources/wag/.
- Providing support for obtaining IRB approvals, IND and/or IDE approval from FDA; establishing subcontract to potential external laboratories/biospecimens repositories; coordinating with suppliers of drugs and arrange for the preparation and packaging of medications for delivery to CCs for the Phase 2CTs and the Collaborative Clinical Research Project.
- Development of a comprehensive framework for evaluating the effectiveness of BACPAC, including the identification of specific metrics for assessment of the BACPAC in achieving the proposed goals.
- Preparation of public-use files for disseminating research resources, such as methods, standard procedures, study manuals, case-report form templates, patient-centric diary templates, and phenotype ascertainment instruments.
- Registration and updating of protocols at ClinicalTrials.gov.
- Submission of manuscripts accepted for publication to PubMed Central according to Federal and NIH policy (http://publicaccess.nih.gov/). Tracking of progress of publications, including PubMed Central reference number, and presentations of findings.
- Conducting additional activities aimed at maximizing the utility and successful adoption of BACPAC Algorithms.
- Developing training seminars or instruction manuals for using the BACPAC Algorithms.
- Based on experience and feedback from trainees, developing a set of training materials (e.g. slides sets, manuals, handouts), an interactive web training program, and an algorithm users’ demo that will provide training on algorithm application and uses.
- Providing user support for both inside and outside of the BACPAC Research Program.
Visit our Institutionally Limited Submission webpage for updates and other announcements.