Concept: Resource Center for Cannabis and Cannabinoid Research

Project Concept Review

Council Date: May 12, 2023

Program Director: Patrick C. Still, Ph.D.  

Background

Cannabis and its cannabinoid constituents have a wide array of pharmacologic actions that have propelled interest from health care providers and the public on the medicinal effects of cannabis products. Currently, 37 states and the District of Columbia have legalized cannabis use for broad medical purposes, reflecting rapidly growing interest in cannabis use for health. The U.S. Food and Drug Administration (FDA) has also approved several natural and synthetic cannabinoids for specific health conditions. Despite widespread availability and established pharmaceutical potential, there are still significant barriers to conducting research at the basic and clinical levels on cannabis and its constituents. To date, several National Institutes of Health (NIH) Institutes and Centers (ICs) have undertaken efforts to leverage the therapeutic opportunities associated with cannabis. Selected examples of NIH-issued Notices of Funding Opportunity (NOFOs) include Exploring the Mechanisms Underlying Analgesic Properties of Minor Cannabinoids and Terpenes (RFA-AT-19-008, R01; RFA-AT-19-009, R21; NOT-AT-20-002, NOT-AT-22-027), Cannabis and Cannabinoid Use in Adult Cancer Patients During Treatment: Assessing Benefits and Harms (RFA-CA-22-052, U01), and Registry of Medical Cannabis Use and Health Outcomes (RFA-DA-23-011, UM1). NIH has also conducted workshops and recently created an NIH-wide cannabis/cannabinoid research funding opportunity webpage. 

In the past few years, NCCIH, in collaboration with other NIH ICs, organized several annual investigator meetings to discuss the progress and challenges of cannabinoids and terpene research in the context of pain. During annual meetings of the investigators who are conducting these projects, several challenges were highlighted as major barriers to productive research efforts. In 2022, we published a Request for Information (RFI, NOT-AT-22-026), to gather more detailed and comprehensive information about scientific interests and barriers to research from investigators conducting research in the field. Examples of the identified barriers include Schedule 1 Status designation, challenges in obtaining and maintaining Drug Enforcement Administration (DEA) licenses, issues related to Investigational New Drug (IND) applications, limited and inconsistently documented studies, lack of validated measures, the increasing diversity of cannabis products, and lack of medical education on cannabis for health care providers. 

Purpose of Proposed Initiative

To address the challenges raised in the RFI, we are proposing the formation of a central Resource Center for Cannabis and Cannabinoid Research intended to reduce barriers to conducting research on cannabis and its constituents as well as to enable researchers to successfully generate more rigorous scientific evidence around the potential clinical uses of cannabis products. The Center is also expected to be a focal point for researchers entering the cannabis research space and to support the development and establishment of research tools and studies that will improve upon and eventually change the landscape of cannabis research. Ultimately, the Center may facilitate research advances through synergistic interactions among experts in relevant commercial, basic science, clinical, and regulatory areas both within the Center itself and in collaboration with other investigators possessing diverse expertise and research backgrounds.

Objectives and Activities

The Center will be supported through a cooperative agreement and is expected to be a comprehensive resource for investigators involved in cannabis research. The Center is expected to be organized into three core components: a Regulatory Compliance Core, an Analytics Best Practice Core, and an Outreach and Community Support Core. The objectives of the Regulatory Compliance Core include establishment of a policy clearinghouse to provide FDA/DEA guidance, as well as organization of standing meetings with FDA/DEA to update regulatory information for research goals. The objectives of the Analytics Best Practice Core include facilitating connections to high-quality research products, supporting the development of research standards and metrics, and building a repository of best practices. The objectives of the Outreach and Community Support Core include organizing annual meetings, connecting investigators to the best sources of quality material, distributing guidance documents, conducting public outreach, and administering seed funding. Seed funds provided by the Resource Center will facilitate researchers’ transition into the field as well as license support and proposal development. 

Examples of Resource Center activities could include, but are not restricted to:

• Establish a policy clearinghouse to provide assistance in navigating FDA/DEA regulatory requirements.
• Organize standing meetings with DEA/FDA to update regulatory information for research goals.
• Support the development of a list of existing vendors to facilitate awareness of currently available cannabis products suitable for use in research.
• Establish a committee to develop research standards and metrics. 
• Build a repository of best practices.
• Organize annual meetings.
• Use social media to provide scientific information.
• Provide webinar series, training series, virtual/hands-on events, workshops at meetings, summer institutes, and grant writing exposure.
• Administer seed funding for license support and proposal development. 
• Identify early career reviewer opportunities.
• Establish a forum to invite NIH Scientific Review Officers (SROs) to provide discussion on peer review to catalyze connections between investigators’ expertise and NIH study section panels to identify appropriate review groups.