Cannabis Clinical Research: Universities Need to Speed Up

By Maria José Delgado Fagundes

To take clinical research off the “frozen shelf,” speed is necessary. The University of São Paulo Ribeirão Preto campus is the institution that publishes the most articles on CBD in the world, with scientific relevance for international research, confirming that Brazil has the potential and vocation to lead this scenario. However, regulatory bodies need to accelerate the approvals of new clinical studies. Could the simplified model adopted in the pandemic context for COVID-19 inspire the solution to current obstacles in the country?

Since 2006, clinical research on cannabis has been allowed in Brazil, although still without specific rules defined by the National Health Surveillance Agency (ANVISA). Our country has shown talent and vocation for scientific research on the plant, even before the boom of cannabis for therapeutic purposes, from 2015 onwards. In this article, the invitation to reflection is about the realization that Brazilian scientific production is creative and excellent, but needs to streamline its validation mechanisms for effective development. 

We produce many scientific papers and falter by not developing Clinical Studies. I highlight, for example, the remarkable production of USP Ribeirão Preto, the first place as the institution that publishes the most articles on Cannabidiol (CBD) in the world. A bibliometric analysis of the 1,167 scientific articles published between 1940 and 2019 pointed out that publications of scientific relevance that serve as a basis for new studies have come out of the educational institution. The university has a production that is more than double that of the second institution, King's College (United Kingdom), followed in third place by the University of Jerusalem (Israel) and in fourth place by the National Institute on Drug Abuse (United States). 

And how is the crop of clinical studies doing? ANVISA recently released the current scenario of Clinical Research for Medicinal Cannabis: 48 protocols: 18 approved, 13 closed or abandoned at the request + 6 protocols under review and 11 awaiting verification. I will highlight here those that are in more advanced Clinical Study phases: 1. Cannabidiol 200 mg/ml - oral solution ü CE 92/2018 ü ICD 10: G40 - Epilepsy ü Protocol: CBD-PRATI-USP-001 (Phase III) and, 2. CARDIOLRX™ Cannabidiol 100mg/ml - oral solution ü CE 53/2021 ü ICD 10: B342 - Coronavirus infection a Protocol: CARDIOL 100-03 (Phase II/III). 

In international clinical research, it is possible to verify on ClinicalTrials.gov – a resource provided by the US National Library of Medicine, which registers research in all 50 American states and in 221 other countries – there are  363 ongoing studies on Medicinal Cannabis, with the aim of  investigating the plant's therapeutic potential for pain treatment. 

Why the Slowness in Cannabis Research?

In the case of Clinical Research on cannabis, what has been observed is that the management of some universities does not always reach the relevance of the subject, which can lead to a huge delay in approval or progress in the Research Ethics Committee (CEP). This climate of slowness and obstacles ends up demotivating interested professors and students, leading to the abandonment of projects conceived based on the plant's potential.

According to the Brazilian Association of Organizations Representing Clinical Research (ABRACRO), one of the main obstacles is the delay in study approval time, which puts Brazil behind countries like Argentina and Chile. The double ethical approval process is one of the main offenders of the time indicator. After the coordinator and CEP's analysis, linked to a hospital or university where the study will be conducted, there is still validation by regulatory bodies.

The Relevance of Brazilian Scientific Production

Scientific research conducted in our country offers a series of benefits to society, with the analysis of the sanitary registration of products from the company or patient associations, and many regulatory and social gains in fostering scientific production, namely:

• 1. Promotes access to innovations, contributes scientific knowledge, provides opportunities for international exchange among researchers, fosters the sharing of protocols and global practices, and also helps the Brazilian population have more representation in research profiles of new therapies, accessing treatments in advance;

• 2. Strengthens regulatory practices for companies or patient associations. As research must be monitored by ANVISA, at the dossier analysis stage, this evaluation will be part of the documentation, ensuring speediness; 

• 3. Favors access to highly motivated investigators; creation, development of “speakers”; training of “opinion leaders”; local data with new medications; protection against copies and exploitation of the Brazilian market.

I emphasize the need to discuss simplified regulatory security. Let's take the example related to Covid-19. With the pandemic situation, the country's regulatory agencies readapted processes to ensure the necessary speed for combating the pandemic, leaving a legacy for the nation, which enhances competitiveness and attractiveness for the international scientific community in the country. 

In that context, ANVISA and the National Commission for Research Ethics (CONEP) were quick to find instruments to adapt the regulatory framework to the pandemic and provided timely responses during the global public health emergency. CONEP, in turn, has strengthened its role in reviews and discussions with study sponsors to ensure progress. 

Could the simplified model adopted in the pandemic scenario for COVID-19 inspire the solution to the current obstacles that Clinical Research for the Cannabis plant is facing? That's the question.

The opinions expressed in this article are personal and the responsibility of their authors.

Maria José Delgado Fagundes is CEO at MJDFagundesconsultoria, lawyer, professional in the compliance area, specialized consultant in health, regulatory systems, pharmaceutical sector, and patient support associations.