Connect with us

Science

The clinical trials roadmap: Everything you need to know about the trialing of new medicines

EuroCan’s chief technical officer, Miguel Fagundes shares his insight on the process.

Published

on

clinical trial
Carefully conducted clinical trials are the fastest and safest way to find effective treatments that help people.

Sponsored feature 

Established in 2018, with medicinal cannabis cultivation and processing facilities established in Lesotho and under construction in Portugal, EuroCan is in the vanguard of the fast-growing, legalised medicinal cannabis industry. 

In this article, EuroCan’s chief technical officer, Miguel Fagundes, a qualified pharmacist specialising in the pharmaceutical industry, gives his insight on the process of clinical trialing of new medical interventions, a topic which is of great relevance in the developing legal cannabis sector, from over-the-counter CBD products to pharmaceutical products prescribed by specialist medical professionals.

What is a clinical trial?

A clinical trial is a research study conducted in humans with the goal of answering specific questions about new therapies, vaccines, diagnostic procedures or new ways of using known treatments (together referred to as “interventions”).

Carefully conducted clinical trials are the fastest and safest way to find effective treatments that help people. Clinical trials are an integral part of the drug and diagnostics discovery and development process.

Before a new intervention can be made available, evidence of its safety and efficacy must be proved by well-designed, well-controlled, and carefully monitored clinical studies in consenting participants. Randomised controlled study is the most reliable medicine study design.

What is measured in a clinical trial?

Clinical trials are performed in human volunteers to provide answers to questions such as “does a treatment work?”,  “does it work better than other treatments?” and “does it have side effects?”

The plan/protocol for clinical trials will describe the results (“endpoints”) that will be measured and the type of information to collect; this is then shared with regulatory authorities to obtain marketing approval, which – when granted – allows a company to market its product for sale.

READ MORE  How cannabis helped me beat blood cancer - twice

Clinical trials also provide important information on the cost-effectiveness of a treatment, the clinical value of a diagnostic test and how a treatment improves quality of life.

How many phases are needed in a clinical trial?

Clinical trials are conducted in phases. Each phase is designed to answer certain questions, while taking steps necessary to safeguard participants.

Every treatment is usually tested in three phases of clinical trials (conducted according to Good Clinical Practice (GCP) guidelines) before regulatory agencies consider the product to be safe and effective.

Clinical trials for the drug candidate commence only after pharmacokinetics and pharmacodynamics have been studied. An overview of the phases of clinical trials can be summarised as follows:

Phase 1: 

What happens to the compound in the body from a safety and tolerability point of view.

6-10 participants

Using a small number of healthy participants, the goal is to study what happens to the investigational compound in the body from a safety and tolerability point of view. Study participants are monitored for the occurrence and severity of side effects.

Phase 2: 

Safest and most effective dosing regimen for the medicine.

20-300 participants

Once the initial safety of the study drug has been confirmed in Phase I trials. Participants are given various doses of the

compound and closely monitored to compare the effects and to determine the safest and most effective dosing regimen.

Phase 3: 

Adequately confirm the benefit and safety of the medicine.

300 – 3,000 participants

These studies allow for the safety and efficacy of the new investigational drug to be compared to other available treatments or placebo. As well as being tested in combination with other therapies. Information obtained is used to determine how the compound is best prescribed to patients in the future.

Post-Marketing Surveillance Trials:

READ MORE  “No link” between cannabis use and heart disease - study

Anyone seeking treatment

Once the medicine has received regulatory approval (or market authorisation) – these studies are designed to evaluate the long-term effects of the drug (broader efficacy and safety information). Under these circumstances, less common adverse events may be detected.  

What’s the relevance to cannabinoids?

Until recently, despite the therapeutic qualities of cannabis which have been well known for many centuries, it has not been easy to carry out testing or research into medicinal cannabis products due to the prevailing legal restrictions.

With the liberalisation of legislative and societal attitudes towards cannabis we expect that growing scientific interest will further explore the clinical relevance of the various cannabinoids found within the cannabis plant, through clinical trials.

As these controlled and scientifically designed studies and trials progress, we anticipate a range of positive results which will demonstrate product safety, efficacy and the potential to improve quality of life for patients, whilst also further educating both scientists and the general public into the potential benefits of cannabinoids.

EuroCan is a division of Botanical Holdings PLC 

www.botanicalholdings.com

 

Industry

Spain approves first cannabis based medicine

The approval for Epidyolex was based on the results of four randomised controlled Phase III trials

Published

on

Spain cannabis: A Spanish flag in the air with an old building behind it

Spain has approved the first cannabis based medicine, Epidyolex for patients with severe conditions such as epilepsy.

Epidyolex, an oral cannabis-based medicine, has been approved in Spain by the Ministry of Health after a large two-year trial. The approval for Epidyolex was based on the results of four randomised controlled Phase III trials. The clinical development of the therapy was spread over 10 different hospitals.

The trial involved over 700 participants with severe forms of epilepsy.

Until recently, there was no distinction between recreational and medicinal cannabis use in Spain which made it difficult to obtain products with higher quantities of 0.02 percent THC.

The medicine will only be available in hospital pharmacies for the treatment of seizures caused by Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS).

Spain and medical cannabis

Speaking at a press conference, neurologist Vicente Villanueva, head of the Refractory Epilepsy Unit of the Hospital Universtiari i Politècnic La Fe de València said the trials have found a 40 percent reduction in seizures.  “As clinicians and researchers, we are satisfied to have these new options”, 

Antonio Gil-Nagel Rein, a neurologist and director of the Epilepsy Program of the Hospital Ruber Internacional de Madrid reported: “The potential improvement of the quality of life in an area where therapeutic options are very small is good news. Access to a new drug with a novel and clinically proven mechanism of action is a reason for hope for patients and satisfaction for specialists.”

Epidyolex received approval from the European Commission in September 2019. This made it the first cannabis-based prescription medicine to receive authorisation.

READ MORE  Integro Medical Clinics: Living with and managing MS

Read more: Can cannabis reduce the side effects of anti-seizure medication?

Continue Reading

Industry

Royal Society of Medicine and Integro Clinics announce pain and cannabis medicines event

The event takes place on October 11 from 8:30 to 17:30. It will explore the potential of cannabis medicines in the field of pain medicine in the UK

Published

on

Event: The Royal Society of Medicine logo in green and red on a white background

The Royal Society of Medicine has announced a collaborative event, Pain and cannabis medicines: Everything you want to know (but were too afraid to ask) in association with Integro Medical Clinics.

The event takes place on October 11 from 8:30 to 17:30. It will explore the potential of cannabis medicines in the field of pain medicine in the UK

Since the legalisation of cannabis medicines on prescription in November 2018, patients and clinicians alike have been awaiting more data or information regarding these medicines. 

The event aims to provide those attending with a comprehensive understanding of the uses of cannabis medicines and the practicalities of using them in their own practice. It will consist of presentations on the history, regulatory environment and pharmacology of cannabis medicines including the use of different cannabis-based medical preparations in treating pain and related symptoms in a wide variety of clinical fields in the context of the current UK regulatory framework. 

Event presentations

The day will feature presentations from international leaders in cannabis medicines such as Professor Raphael Mechoulam, the chemist who discovered the endocannabinoid system and THC, Dr Anthony Ordman, Leading UK Consultant in Pain Medicine and previous President of the Pain Medicine Section of the Royal Society of Medicine and Dr Arno Hazekamp PhD, who worked as Head of Research and Education at Bedrocan, the first European company to produce EU GMP grade cannabis medicines.  

If you wish to sign up, please click here.

Event speakers
Dr Anthony Ordman, Consultant in Pain Medicine

Event: A black and white headshot of Dr Anthony Ordman Founder of the highly respected Chronic Pain Clinic at London’s Royal Free Hospital, he is one of the UK’s most experienced specialists in the treatment of pain. For his contributions to Pain Medicine, Dr Ordman was awarded a Fellowship of the Royal College of Physicians in 2005, and he is the Immediate Past President of the Pain Medicine Section of the Royal Society of Medicine. Dr Ordman is also Senior Medical Consultant and Lead Clinician at Integro Medical Clinics and has a special interest in the potential benefits of cannabis medicines in pain medicine.

READ MORE  Study: How long do the effects of cannabis last?
Alex Fraser, Patient Access Lead at GrowPharma

Event: A black and white headshot of guest speaker Alex FraserAlex Fraser is a leading medical cannabis patient advocate. He is a patient himself having been diagnosed with Crohn’s Disease in 2010 at 19 years old. In 2014 he founded the United Patients Alliance and has since appeared on mainstream media multiple times, including on the BBC and ITV, to highlight the urgent need for access to cannabis medicines for the many patients who may benefit from them. He has taken delegations of patients to parliament to give testimony to politicians at the highest levels and organised educational events, rallies and protests calling for law change on medical cannabis. In February 2019 Alex joined Grow Pharma, one of the leading suppliers of cannabis medicines in the UK, as their patient access lead. He utilises his extensive knowledge of medical cannabis, his understanding of patient needs and his network in the industry to ensure patient voices are heard and represented. His work includes informing top-level policymakers, educating healthcare professionals and conceiving and running projects that increase general awareness and provide practical help for patients.

Professor Raphael Mechoulam, Professor of Medicinal Chemistry at the Hebrew University of Jerusalem in Israel

Event: A black and white headshot Most well-known for the total synthesis of delta-9 tetrahydrocannabinol (THC) and the discovery of the Endocannabinoid System. Since the inception of his research in the 60s, Professor Mechoulam has been nominated for over 25 academic awards, including the Heinrich Wieland Prize (2004), an Honorary doctorate from Complutense University (2006), the Israel Prize in Exact Sciences – chemistry (2000), the Israel Chemical Society Prize for excellence in research (2009) and EMET Prize in Exact Sciences – Chemistry (2012

READ MORE  Novel cannabinoid could treat cancer-related anorexia
Dr Sally Ghazaleh, Consultant Pain Specialist

Event: A black and white headshot of a guest speakerDr Sally Ghazaleh, is a Pain Management Consultant at the Whittington Hospital, and the National Hospital of Neurology and Neurosurgery, London. She qualified from the University of Szeged Medical School, Hungary in 2000, and then completed her specialist training in the Anaesthesia and Intensive Care Medicine at Semmelweis University in 2007. She went on a fellowship at University College Hospital, London, to gain her higher degree in Pain Medicine

During her time at the pain management Centre at University College Hospital, she gained extensive experience in dealing with and managing patients with complex multiple pain problems. She is accomplished at a variety of interventional and non-interventional treatments for this specific patient group. Sally specializes in managing patients with lower back pain, neck pain, neuropathic pain, abdominal pain, cancer pain, complex regional pain syndrome, post-stroke pain and Fibromyalgia. She has a particular interest in bladder and abdominal pain in women, and women’s health in general.

Sponsored post about British Cannabis Group

Read more: How Medical cannabis can help relieve the symptoms of migraine

Continue Reading

Case Studies

CBD brand created by a Welsh athlete releases report on potential health benefits of CBD

The Healthcare Technology Centre (HTC) partners with Welsh brand Hemp Heroes to discover the potential health benefits of CBD products. 

Published

on

Welsh: A cbd oil bottle containing yellow oil has a dropper being placed into it

The Healthcare Technology Centre (HTC) partners with Welsh brand Hemp Heros to discover the potential health benefits of CBD products.

The Welsh HTC led by Swansea University Medical School collaborated with Swansea and Ireland based company, Hemp Heros. Hemp Heros was co-founded by  David Hartigan and martial arts athlete John Philips.

The report was the result of several months of research into the benefits of CBD- based products on a range of conditions. These included epilepsy, side effects of chemotherapy, multiple sclerosis (MS), stress and anxiety.

Speaking with Cannabis Health News, Hemp Heros co-founder David Hartigan explains how an interest in martial arts helped him to meet John and start the company.

Athletes and CBD

David said: “It’s a bit of an interesting story how myself and John met. My background is in business consultancy and I’ve always been into martial arts since I was a kid. John asked my brother who is a musician to do some walkout music for UFC. As John was only newly signed at that time, I wondered if he had anyone to help him with marketing and sponsors. I became John’s manager.”

He added: “I started looking at CBD companies because athletes were starting to use it. I thought there was a huge opportunity to get John sponsored by a company. We did get a few samples from different companies but the quality was hit or miss. Even the instructions when you were trying to read it could be confusing.”

John’s first experience with CBD was not actually on himself but his dog, Alfie. When he became ill, John began treating him with CBD after realising that Tramadol was not working. The vet had exhausted all options for treatment but CBD helped him to recover.

David said: “I have an uncle who is a powerlifter and he has a couple of Irish records. He has a number of injuries he started taking CBD for pain and inflammation. At one stage, he couldn’t even change the gear stick in his car but he has much better mobility and pain management now. So between my story, John’s and the lack of transparency in the industry in the market, we decided to try an investigation.”

READ MORE  ‘Historic moment’ as first South African medical cannabis flower arrives in UK

David spent six to eight months researching the whole industry speaking to anyone he could about hemp or CBD. He also joined the board for the Irish Hemp Cooperative. They spent months researching everything before finding a supplier to get them started. The brand has now grown from three or four products to over twenty including a successful pet range.

Hemp heros: A man wearing a black t-shirt stands next to a dog

Welsh university study

The brand partnered with Swansea University and are part of the accelerator programme there. They had planned to participate in studies on CBD but unfortunately, COVID hit just as they began to start the studies. The Welsh Accelerate programme aims to create lasting economic value by helping innovators in Wales to translate their ideas into solutions, enabling them to be adopted in health and care.

David explained: “Dr Daniel Rees, who is one of the researchers at Swansea University reached out to us. He had seen our products around the place and wanted to know if we would be interested to do some studies in the life sciences department.”

“The whole idea of the Accelerator programme is to identify potential services or products that can have a positive impact on people’s lives. It improves the lives of the end-user. Dan highlighted that very little research was done on CBD in this context. We are passionate about transparency so we really wanted to push the research. However just as we had hoped to start lab tests, COVID hit.”

The COVID situation didn’t force a complete shutdown but changed the direction of the study for the researchers. As the colleges were closed, there were no ways of getting anyone into a lab for testing so David and the team decided to go down the road of research producing a report on the effectiveness of CBD. The initial study paves the way for future research activities around four key pillars: pain, sleep, anxiety, and recovery.

READ MORE  “No link” between cannabis use and heart disease - study

Lab study to research reports

“What we did was change gears so instead of a lab-based study, we are going to do a more research-based one. We researched the case studies for CBD and hemp-based products along with the history behind them. We looked at different cannabinoids like CBD or CBDA, different terpenes and then unique extraction methods. We went into deep dives on what studies were there for cancer, sleep, inflammation, pain and took them as different pillars. This is what our report contains.”

He added: “We wanted to show some form of evidence for how CBD could possibly work for Parkinson’s by looking at the findings, how the studies are performed? What is the wider picture for sleep or inflammation? This could give us a foundation to build on.”

The next step

Hemp Heros started to submit an application called Smart Partnership to the University for the management side. This would allow them to secure funding to get an associate who would work between the Welsh brand and the university.

“It gives the company the tools and techniques to use these findings and apply them so you can continue your work. We have all of this anecdotal evidence on why people use our products but then the smart partnership would allow us to do a deeper dive and validate what our understandings are.”

He explained: “We have set out three pillars essentially. Sleep is one that we want to investigate and they have a sleep lab there. We want to start out with something quite simple like 20 participants with sleep issues and give them a protocol. They log everything then they take a set dose of our product for a week to see what the impact is. The next step would be to go into the sleep lab to actually monitor what someone’s sleep pattern is, how quickly it works and what the effects are.”

READ MORE  The three barriers blocking access to cannabis in the UK

Welsh: A man walking a dog on a lead across a beach

As well as the studies and research they have conducted, the brand is still planning to work with different athletes.

“Should athletes be using prescription pain medications to help with their pain to get through the day? They could have a more natural alternative with no side effects. Your body is already built for cannabinoids, not really for painkillers. That’s why a lot of people have issues with their kidneys when they are on painkillers for so long because they are trying to process everything.”

David is also involved in the advocacy side. He believes that Ireland needs to match the European level to make sure it isn’t left behind. He sits on the Irish Hemp Cooperative Board who are trying to change the laws.

“There are a couple of TDS (Ministers) who said that they would be interested in the sports angle. We aren’t looking for full-blown cannabis legal for everyone but we actually want to just look at hemp and the production because you can get a license but then technically what you grow is illegal. There is a massive gap in the law where the two laws don’t match and we don’t match at the European level. We need to make sure we are on par with our international counterparts.”

Read more: Pain, anxiety and sleep are the most common reasons people use CBD

Continue Reading

Trending

Cannabis Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. All content on this site is intended for educational purposes, please seek professional medical advice if you are concerned about any of the issues raised.

Copyright © 2021 H&W Media Ltd.