CERSI P.I.s and Collaborators: Danya Qato, PharmD, MPH, Ph.D., UMB School of Medicine, Bethany DiPaula, PharmD UMB School of Pharmacy, Megan J. Ehret, PharmD, MS, UMB School of Pharmacy
FDA SMEs and Collaborators: Sara Eggers, Ph.D., CDER, FDA, Reza Kazemi-Tabriz, Ph.D., CDER FDA
Project Description and Goals
The primary goal of this project is to support the FDA's CDER effort to “develop a comprehensive systems model of the opioid crisis” by providing summary-level data that can be incorporated into the model using a diversity of datasets that cut across the privately and publicly-insured.
While the FDA has focused other efforts on better elucidating the trajectory from opioid use initiation to OUD, our focus in this proposal is to enhance models by illuminating factors associated with OUD treatment trajectories and the differential impact of modality type on treatment remission and recovery. Our work focuses on the chronic (and relapsing) nature of OUD and the cyclical nature of treatment and will thus expand the scope of previously conducted research by characterizing the temporal patterns and outcomes associated with single and multiple, sequential treatment modalities. Such an approach provides a more textured understanding of the natural history of OUD treatment in the long term.
Specifically, in this project, we seek to utilize longitudinal data from the publicly-insured and commercially-insured adult population to characterize temporal patterns of treatment modalities and examine the differential impact of temporal patterns of treatment modalities on critical health outcomes.
This work fits squarely within the FDA’s effort to “develop methods and tools to improve and streamline clinical and postmarketing evaluation” including specifically improving “approaches to leveraging large, complex data to inform regulatory decision-making, including the use of “real world” data sources.” In 2018, FDA's Center for Drug Evaluation and Research (CDER) began an effort to develop a comprehensive systems model of the opioid crisis. The purpose of the model is to help FDA better understand a) the complexity of the underlying mechanisms of the crisis, and b) potential impacts – including desired outcomes and unintended consequences— of possible policy actions. The anticipated research impact of our proposed work will be to: 1) inform FDA’s opioid modeling efforts that help with identifying potential high-impact interventions, assessing intended and potential unintended consequences of policies and identifying needs for further research; and 2) to contribute to the broader public health knowledge of the current state of treatment for opioid use disorder.
The University of Maryland CERSI will be responsible for achieving the goals and objectives of this project, including convening of project meetings, submission of DUAs, data stewardship, study design, study conduct, and data analysis, and preparation of manuscripts and dissemination of findings. Pharmaceutical Research Computing (PRC) is housed in the same department as the PI (Qato) and has extensive experience with data stewardship. PRC will be responsible to serve as custodians of the data and to support development of analytic files based on the guidance of the M-CERSI team and the FDA.