FDA reviews the submitted IND. The sponsor must wait 30 calendar days following IND submission before initiating any clinical trials, unless FDA notifies the sponsor that the trials may proceed sooner. During this time, FDA has an opportunity to review the submission for safety to assure that research subjects will not be subjected to unreasonable risk.
To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as cannabis, researchers need to work with the FDA and submit an IND application to CDER. The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. An IND includes protocols describing proposed studies, the qualifications of the investigators who will conduct the clinical studies, and assurances of informed consent and protection of the rights, safety, and welfare of the human subjects. The FDA reviews the IND to ensure that the proposed studies, generally referred to as “clinical trials,” do not place human subjects at an unreasonable risk of harm. The FDA also requires obtaining the informed consent of trial subjects and human subject protection in the conduct of the clinical trials. For research intending to develop an animal drug product, researchers would establish an INAD file with the Center for Veterinary Medicine (CVM) to conduct their research, rather than an IND with CDER.
Conducting clinical research using cannabis-derived substances that are considered controlled substances under the CSA often involves interactions with several federal agencies. For example:
Sponsor obtains pre-IND number through CDER review division to request a pre-IND meeting. For new animal drug research, a sponsor may engage with CVM to establish an INAD file. A pre-IND meeting with CDER is optional, and an opportunity to obtain FDA guidance on sponsor research plans and required content for an IND submission.
The sponsor sends a copy of the IND and clinical protocol, including a LOA (if applicable), to FDA.
For nonclinical research, including research conducted under an INAD file submitted established with CVM, there is no requirement of prior authorization of the protocol by FDA before the investigators may proceed with a protocol registration application submitted to DEA. For these nonclinical protocols, investigators may immediately pursue investigator and study site licensure, and protocol registration with DEA, so they may then obtain their Schedule I cannabis-derived study drug from supplier.
A long-running fight to overturn federal “monopoly”
The constraints on research cannabis also has impeded the pathway to drug development because the NIDA facility’s cannabis could only be used for academic research, not for prescription drug development. A drug studied in phase 3 clinical trials — what’s required before submitting for approval from the Food and Drug Administration — must be the same as what’s later marketed.
Medical Marijuana’s ‘Catch-22’: Limits On Research Hinder Patient Relief
“It is a big disconnect,” says Dr. Igor Grant, a psychiatry professor and director of the Center for Medicinal Cannabis Research at University of California, San Diego.
In 2001, Dr. Lyle Craker, a prominent plant biologist, first applied for a license to cultivate marijuana for research — only to encounter years of delay that kicked off a prolonged court battle with the DEA, which has to greenlight research into Schedule 1 drugs like cannabis.
Sisley has long taken issue with the supply of cannabis coming from the NIDA facility in Mississippi — in particular, how it’s processed. She used cannabis produced there in her recently published clinical trial on treating PTSD in military veterans.
Content type: Brief research report
Content type: Original research
Content type: Original research
Recurrent priapism in the setting of cannabis use
For more information on the series and details on how to submit, you can read the call for papers here.
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