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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.

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

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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.

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:

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

 

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How THC and CBD work together in the brain – new study

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How THC and CBD work together in the brain – new study

New findings on how CBD and THC – the psychoactive compound in cannabis – affect the brain when administered together, could help to develop new cannabinoid therapeutics, scientists say.

A study has investigated the impact on the brain of CBD and THC, both as separate entities and when co-administered.

Researchers at University College London (UCL) analysed data from previous studies, including one which used functional Magnetic Resonance Imaging (fMRI) technology to measure brain activity in participants taking CBD and THC.

For the first time, they explored the response of the striatum region of the brain – a major part of the motor and reward systems. This is a critical component of numerous aspects of cognition, including motor and action planning, decision-making and motivation.

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One study compared inhaled cannabis containing 8 mg THC, 8 mg THC + 10 mg CBD and a placebo. It showed strong disruptive effects of both THC and THC + CBD on connectivity in the associative and sensorimotor networks.

However it also identified a “specific effect of THC” in the limbic striatum network which was not present in the THC + CBD condition.

In a second study, testing oral 600 mg CBD versus placebo, CBD increased connectivity in the associative network, but produced only relatively minor disruptions in the limbic and sensorimotor networks.

The study concludes that THC “strongly disrupts striato-cortical networks” but that this effect is mitigated by the co-administration of CBD.

It states: “Oral CBD administered has a more complex effect profile of relative increases and decreases in connectivity.

“The insula [part of the brain implemented in diverse functions including emotions and self-awareness] emerges as a key region affected by cannabinoid-induced changes in functional connectivity, with potential implications for understanding cannabis-related disorders, and the development of cannabinoid therapeutics.”

This is the first report in human subjects of data from THC, THC + CBD and CBD use achieved “using a unified set of analysis methods, and with all comparisons performed in a placebo-controlled, double-blind design”.

Read the full report here.

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Five new cannabis studies to have on your radar

The latest scientific papers exploring cannabis and its impact on health and society.

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Five new cannabis studies to have on your radar

Get up to date with the latest cannabis-related research from across the globe.

Over the past few weeks, we’ve seen papers published around inaccurate labelling, the effects of cannabis on Covid-19, the impact of legalisation in Uruguay and how cannabis users might require more sedation during medical procedures.

Read on for five significant studies to dive into.

Lower Covid-19 severity among cannabis users

A recent study has discovered an association between lower Covid-19 severity and cannabis use among hospitalised patients.

The researchers aimed to assess whether current cannabis users hospitalised for Covid-19 had different outcomes compared to non-users through a retrospective analysis of 1,831 patients admitted to UCLA Medical Centre in California.

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Analysis of the data found that cannabis users had significantly better outcomes compared to non-users, shorter hospitalisation, lower ICU admission rates and less need for mechanical ventilation.

Interestingly, the researchers also found that active users had lower levels of inflammatory markers upon admission than non-users.

The authors of the study concluded: “This retrospective cohort study suggests that active marijuana users hospitalised with COVID-19 had better clinical outcomes compared with non-users. However, our results need to be interpreted with caution given the limitations of a retrospective analysis.

“Prospective and observational studies will better help elucidate the effects of marijuana use in COVID-19 patients.”

Cannabis users require more sedation for endoscopy

According to new research, patients who use cannabis required higher levels of sedation during gastric endoscopies than non-users.

As cannabis is legalised in more places and usage continues to rise, researchers in Canada said clinicians should be aware of patients’ cannabis consumption and prepare themselves for increased sedation and the risks that come with it.

The authors of the study conducted a prospective cohort study of 419 adult outpatients undergoing endoscopic procedures at three Canadian centres. Procedures were conducted under conscious sedation, which leaves the patient relaxed and comfortable but partially conscious during the procedure.

Cannabis use was associated with increased odds of requiring higher total sedation during gastroscopy, an endoscopic procedure that begins with the insertion of a tube and camera through the throat.

Legalisation not associated with increased cannabis use among young people

A recent study from researchers in Uruguay found that the use of cannabis following legalisation decreased among teenagers.

Uruguay was the first country in the world to legalise and regulate recreational cannabis. Since legalising the drug in 2016, the country is now regarded as a pioneer, paving the way for other countries like Canada, Mexico and Malta.

Using data from cross-sectional surveys of secondary students in Uruguay and Chile, the study evaluated changes in the prevalence of past-year, past-month and any risky and frequent cannabis use following the enactment and implementation of cannabis legalisation

“The legalisation of recreational cannabis in Uruguay was not associated with overall increases in either past-year/past-month cannabis use or with multi-year changes in any risky and frequent cannabis use among young people,” the authors stated in the paper’s abstract.

Current cannabis labelling system “doesn’t tell you much”

Labels like indica, sativa and hybrid—commonly used to distinguish one category of cannabis from another—tell consumers little about what’s in their product and could be confusing or misleading, suggests a new study of nearly 90,000 samples across six states in America.

Published on 19 May in the journal PLOS One, the research constitutes the largest analysis to date of the chemical composition of cannabis products.

It finds that commercial labels “do not consistently align with the observed chemical diversity” of the product. The authors are now calling for a “weed labelling system” akin to the Food and Drug Administration’s “nutrition facts panel” for food.

“Our findings suggest that the prevailing labelling system is not an effective or safe way to provide information about these products,” said co-author Brian Keegan, an assistant professor of Information Science at CU Boulder.

“This is a real challenge for an industry that is trying to professionalise itself.”

Cannabis dependence treatment is effective in tackling common co-morbidities

Earlier this month, Australian researchers released a paper looking into the effectiveness of cannabis dependency treatment on common co-morbidities, including mood, sleep and pain problems.

The researchers found that the treatment helped decrease anxiety, stress and sleep disturbance among the cohort of 128 cannabis-dependent participants.

The analysis used data from a 12-week double-blind placebo-controlled trial testing the effectiveness of the cannabis-based medicine nabiximols against placebo in reducing illicit cannabis use.

The researchers found that there was “no evidence” that nabiximols treatment is a barrier to reducing co-morbid symptoms. In fact, they found that the treatment reduced illicit cannabis use and improved comorbidity symptoms, even when participants were not able to achieve abstinence.

 

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Research finds cannabis consumers may require more sedation

Consumers required higher levels of sedation during endoscopic procedures than non-users

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Research finds cannabis consumers may require more sedation

Experts have highlighted the need for doctors to be more aware of their patients cannabis use, as research suggests consumers may require higher levels of sedation.

As cannabis is legalised in more places and usage continues to rise, researchers in Canada said clinicians should be aware of patients’ cannabis consumption, and prepare themselves for increased sedation and the risks that come with it.

It comes as a new study has associated cannabinoid use with increased odds of requiring higher total sedation during gastric endoscopies – a procedure that begins with the insertion of a tube and camera through the throat – than non-users.

The authors of the study conducted a prospective cohort study of 419 adult outpatients undergoing endoscopic procedures at three Canadian centres.

Procedures were conducted under conscious sedation, which leaves the patient relaxed and comfortable but partially conscious during the procedure.

US research programme studies cannabinoids in ovarian cancer

Researchers did not examine its impact on propofol sedation, which is more commonly used in the UK and US so more research would be needed to determine the wider impact of cannabis use on sedation.

“Patients didn’t have increased awareness or discomfort during procedures, but they did require more drugs,” said Yasmin Nasser, MD, PhD, lead researcher on the study and assistant professor at Snyder Institute for Chronic Diseases at the University of Calgary.

Each patient completed two questionnaires, one before the procedure about their cannabis use and another afterwards, indicating their awareness and comfort level during the procedure. The questionnaires were analysed along with details about the use of the sedatives midazolam, fentanyl and diphenhydramine during the procedure.

Cannabis use was associated with increased odds of requiring higher total sedation—defined as more than 5 mg of midazolam, or more than 100 mcg of fentanyl, or the need for diphenhydramine.

Interestingly, cannabis use was not associated with higher use of sedation during colonoscopy. Researchers said this could be because gastroscopy generally requires more sedation than colonoscopy due to the irritation caused in the upper part of the gastrointestinal tract.

Cannabinoid use was not independently associated with fentanyl use or adverse events, nor was it associated with intra-procedural awareness or discomfort, the authors found.

This study looked at whether patients were users or non-users of cannabis, but did not examine the timing, quantity or route of cannabis intake prior to the procedure. Researchers say these variables could be the basis for future studies.

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