There remain substantial shortcomings in data related to the safety, efficacy, and use behavior among medicinal cannabis patients. Due to the diversity of cannabis products, the substantial number of therapeutic targets, and legalized access through legislative action, clinical trials alone would be insufficient to provide needed data. An alternative approach is the conduct of large observational research studies to glean insight into therapeutic areas where certain types of cannabis products demonstrate positive or negative impacts on patient-level health and functioning to inform clinical decision making.

The Realm of Caring Observational Research Registry (ORR) is an ongoing IRB-approved longitudinal research project conducted in collaboration with the Johns Hopkins University School of Medicine examining the health effects of medicinal cannabis use. The ORR was established in 2016 as a national patient registry with the aim of characterizing the health of patients using cannabis for medicinal purposes, compared with controls. Building on this work, the Cannabis and Health Research Initiative (CHRI) recently launched a longitudinal observational research study (National Cannabis Study; NCS) to evaluate the health and functioning of adults newly initiating medicinal cannabis use. Participants complete baseline assessments prior to initiating medicinal cannabis and again 1, 3, and 12 months after starting cannabis use. Two sub-studies will be conducted to evaluate detailed cannabis use behavior using smartphone-based assessments and clinical chemistry testing of blood specimens obtained at baseline and 12-months after use initiation. Data from these and other observational studies will be put into a data repository that will be made available as a research resource for scientists and regulators.

Media campaigns are being developed to raise awareness and increase enrollment towards a target of at least 10,000 participants over the next 3 years. The data repository currently has data from over 3,000 participants from multiple studies, with more data expected between now and the conference. The CHRI pilot funding program will support junior scientists seeking to utilize data from the repository to address defined hypotheses. Access to the repository, description of the repository contents, and details of the pilot RFA will be provided during the presentation.

The NCS provides a model for observational research studies, and the CHRI data repository will serve as a valuable research resource for the scientific community. Collectively, these projects will significantly advance knowledge about the patient-level health effects of medicinal cannabis use and improve clinical decision-making.

Learning Objectives:

• Understand the need for large observational research such as the CHRI and NCS to address evidence gaps in medicinal cannabis research

• Describe CHRI and NCS methods, including longitudinal assessments and sub-studies

• Identify how the CHRI data repository supports research on patient outcomes