Clinical trials of medical cannabis

Medical Cannabis Clinical Trials

The field of medical cannabis research is rapidly evolving, driven by ongoing clinical trials and scientific breakthroughs that shed light on the potential therapeutic applications of cannabinoids. From regulatory frameworks to scientific advancements, notable progress is being made worldwide. This article examines the recent developments and challenges faced in medical cannabis research, with a particular focus on Europe and the United States.

Clinical trials of medical cannabis

One of the major challenges in medical cannabis research is the tight regulation surrounding cannabis in most European countries. Obtaining licenses and approvals for clinical trials can be complex and time-consuming. Similarly, in the United States, federal restrictions and varying state-level regulations pose hurdles for researchers. Moreover, limited access to standardized cannabis products for clinical trials further complicates the process, potentially impacting the reliability and validity of trial results.

Compared to traditional pharmaceuticals, the infrastructure for conducting clinical trials with cannabis is relatively underdeveloped. In Europe, there is a shortage of specialized research centers and experienced staff, hindering the progress of research. Additionally, stigma and the classification of cannabis as a controlled substance make securing funding a challenge. Traditional funding sources may be hesitant to support cannabis-related research, limiting the financial resources available for robust clinical trials.

Ethical concerns and public perception also play a significant role in medical cannabis research. The stigma surrounding cannabis can influence patient recruitment and the support received from the medical community. Ensuring informed consent and addressing potential risks associated with cannabis use are critical considerations. Public perception and attitudes towards cannabis research need to align with scientific advancements in order to fully explore its therapeutic potential.

Despite the challenges, notable advancements have been made in medical cannabis research. In Europe, Zynerba Pharmaceuticals presented positive results from a study on Zygel, the first pharmaceutical-produced cannabidiol, in children and adolescents with Fragile X Syndrome. Corbus Pharmaceuticals made progress with lenabasum, a cannabinoid receptor type 2 (CBS), being investigated for systemic lupus erythematosus. Tetra Bio-Pharma received orphan medicinal product designation for the cannabinoid cream PPP004, a potential treatment for epidermolysis bullosa. These developments highlight the growing interest and potential benefits of cannabis-based therapies for various health conditions.

The field of medical cannabis research is witnessing a transformative phase, with advancements in understanding and potential therapeutic applications. However, challenges such as regulatory hurdles, limited access, infrastructure limitations, funding constraints, ethical considerations, and public perception continue to impact progress. Efforts are underway to address these challenges and expand clinical trial activity in Europe and the United States. As attitudes and regulations evolve, it is expected that barriers will gradually be overcome, leading to improved patient care and the development of evidence-based guidelines for medical cannabis use. Continued research in this field holds great promise for unlocking the full potential of cannabinoids and providing effective medical solutions for those in need.

Lumis Life Science Consulting, a consultancy firm specialized in Clinical Research offering regulatory services, clinic trial processes and oversight, recognizes the growing importance of cannabis research. With a team of experienced professionals and deep industry expertise, Lumis is well-positioned to provide strategic guidance and advisory services to organizations involved in medical cannabis research. Our comprehensive understanding of regulatory landscapes, market dynamics, and scientific advancements enables them to assist clients in navigating complex challenges and optimizing their cannabis research initiatives. By collaborating with Lumis, organizations can leverage their insights and expertise to drive innovation, shape policies, and ultimately contribute to the advancement of medical cannabis research.

The article was written by Heike Schön and Andrés Aguilar Caro

Download the slides Heike Schön and Liam Spencer presented at the Med-Cannabis 2023 Conference. The need for more randomised controlled trials (RCTs) was apparent during the conference and Heike Schön presented possible solutions for conducting these studies. Liam Spencer discussed the complex medicinal cannabis regulatory landscape and highlighted the EMA’s call for scientific data for Cannabis sativa L., flos (ref: EMA/HMPC/697513/2022).

This indicates an increased interest from regulators and potentially a shift to more market authorisations. For some cannabis-based medicines, considering orphan designations and SME status is recommended to streamline the approval pathway. For further information, check out our slides below.

Presentation on clinical trial considerations for medical cannabis
Heike Schoen - managing director Lumis

This post was written by Heike Schön. Heike is the Managing Director of Lumis and has worked in management positions in clinical research for more than 20 years. Her experience ranges from conducting national and international Phase I clinical trials all the way to registration and post‑marketing activities. She had positions within contract research organisations (CROs) and in the biotechnology industry.

Heike holds a master’s degree in psychology from Freie Universität Berlin and a master’s degree in business administration from Schiller International University. Since 2002, she has been active in the Association of Clinical Research Professionals (ACRP) where she also served as a member of the Board of Trustees and as its Chair in 2010. Heike is a regular speaker at international conferences and publishes within clinical research and medical device magazines.

Read more on our services about oversight management for clinical trials

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