Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center

ABSTRACT
The goal of this U24 application is to establish the Data Integration, Algorithm Development and Operations
Management Center (DAC) for NIAMS' Back Pain Consortium (BACPAC) Research Program to ensure that
the research objectives are met. The objectives of BACPAC include (i) discovery of lower back pain
mechanisms through expert application of clinical and translational medicine methodologies; (ii) identification of
new interventions targeted to individual patients through knowledge of established and newly discovered
mechanisms; and (iii) evaluation of promising interventions to determine those that warrant further study,
potentially leading to regulatory approval. A successful BACPAC research program will be based on cutting
edge technologies and reflect the patient-centric focus that is critical to any investigation in this chronic and
burdensome disease. Central to this success will be an innovative, forward-looking, and productive DAC that
brings cohesion to research performed by the participating Mechanistic Research Centers, Technology
Research Sites, and Phase 2 Clinical Trials Centers. DAC Investigators will share their vision and provide
scientific leadership and organizational support to the BACPAC Consortium. Our research plan consists of
designing and conducting clinical trials with precision interventions in stratified patient populations. Precision
medicine interventions that focus on identifying the best treatments for individual patients, instead of the best
treatments for the most patients, could improve overall outcomes among this heterogenous patient population.
Key elements of the DAC that will enhance collaboration and research progress include experienced
leadership, innovative design and analysis methodologies (e.g., sequential adaptive designs, machine
learning, neural networks, Q-learning), comprehensive research operations support, a state-of-the-art data
management and integration system, and superior administrative support. Our communications infrastructure
will provide both public and private websites and a social media presence to effectively disseminate
appropriate information to BACPAC investigators, participants, and the public. We will develop a secure, user-
friendly advanced data management and integration system that includes web-based access for surveys, data
entry, research management (including comprehensive reporting, biosample tracking and performance-based
reimbursement tools), integration with external applications, and quality control. Our research operations and
administration teams will provide a solid foundation to the BACPAC Research Program by facilitating meetings,
collaborative document preparation, tracking of regulatory compliance, and support for abstract and publication
preparation across the BACPAC Consortium. Together, this integrated structure will set the stage for
technology assessments, solicitation of patient input and utilities, and the evaluation of high-impact
interventions through the innovative design and sound execution of clinical trials, leading to effective
personalized treatment approaches for patients with chronic lower back pain.

Grant Number: 4U24AR076730-02
NIH Institute/Center: NIH
Principal Investigator: Kevin Anstrom