Cannabis-derived pain relief is a new approach to cancer treatment that has shown promise in recent clinical trials. A team of scientists and entrepreneurs are working on an innovative way to use real-world data from the cannabis market to help develop this treatment.
The research shows pain relieving effects of cbd is a company that is aiming to develop cannabis-derived pain relief for people with cancer.
Work-life balance has been restored (to a degree), our carbon footprint has been reduced (somewhat), and a communications revolution has begun (thank-you Zoom).
When it came to discovering vaccinations in months rather than years, need was the mother of innovation, and the United Kingdom led the way.
The fact that the timeframe was cut in half was due in large part to the new method, since authorities approved the Oxford-AstraZeneca vaccine on December 2, 2020, based on real-world data.
If the vaccine had to go through the traditional three-phase process of randomised clinical trials, the process could have taken a decade and cost hundreds of millions of pounds.
The success of vaccines sets the tone.
To be fair, there is a rationale for the regulatory hoop-jumping. It exists to avoid the repetition of drug scandals like thalidomide, which have claimed the lives of thousands of people.
However, in the midst of an international crisis, British authorities accepted real-world evidence from human challenge trials in which healthy people were infected with Covid.
It’s a shift in strategy that may forever transform the environment for those researching new medicines and therapies for the UK market.
Britain’s regulatory authorities have indicated they are willing to consider real-world data in some situations when licensing medicines for use in the UK, in a reference to the simplified procedure that brought vaccinations to market in record speed.
Without a question, the Medicines and Healthcare Products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) are taking major steps forward (NICE).
CBD Science Group PLC, which is well aware of the trend, thinks that this evidence-based regulatory approach will be the key to unlocking the cannabis medications it is developing.
Timeline has been accelerated.
“Dr [June] Raine and her newly formed team at the MHRA have made it clear that they are committed to an integrated process in coordination with NICE, to use real-world evidence; to accelerate, develop, and deploy innovative medicines to rapidly improve patient access,” says Graeme McFarlane, CBD Science’s chief commercial officer.
“It is obvious that the lessons learned from the Covid-19 immunization campaign are being applied to the development of new medications in the future.”
The firm intends to conduct large-scale real-world evidence studies to evaluate the efficacy of cannabis in cancer patients who have exhausted all other options for pain management. This would provide an alternative to commonly used opioids, which may interfere with a patient’s cancer treatment plan or cause undesirable side effects.
When putting up its final submissions, CBD Science researchers would look at a “more comprehensive data set” than the basic pain ratings used in conventional clinical studies. The aim is to have a better understanding of how cannabis-based analgesics are used.
“We’ll look at other aspects that are important to individuals, as well as safety and effectiveness,” McFarlane says.
“To account for broader wellness outcomes, we’ll use a variety of methods, including patient self-reporting, physician reporting, and other tools.”
“We’ll also look at the health economics of these medicines, determining the actual economic worth of these natural medicines.”
Randomized controlled trials (RCTs), as an alternative, are not intended to take in the larger datasets required to evaluate and review a medicine’s performance in a real-world context, according to McFarlane.
“We’ve seen it before: just because a medication works well in a clinical trial environment doesn’t imply it’ll function well in real life.”
CBD Science is to begin its trials in the second quarter of next year, after securing a reliable supply chain that would fulfill the study’s criteria.
“At first, these will be large-scale trials with between 100 and 200 patients, with several centers in the UK and Europe.” This is what a successful real-world approach requires, according to McFarlane.
Throughout the research, the firm intends to publish early findings.
According to CBD Science’s chief operating officer (COO), this strategy of constantly reporting on its efforts would offer “a wonderful tool to educate doctors and continue to increase access for the millions of individuals suffering.”
In the second quarter of 2023, they should have enough real-world data to present to UK regulatory authorities.
Crowdfunding is currently in progress.
CBD Science is now crowdfunding to fund early studies, with a goal of raising £2 million.
Longer term, it is expected to seek money from the stock market in order to grow and develop the company.
A clinical advisory board that wouldn’t seem out of place at a large-cap pharma firm is lending its support to the company (and, by extension, offering third-party validation of its approach).
Professor Mike Bewick, the former deputy medical director of NHS England, and Professor Sam Ahmedzai, the cancer head at the National Institute for Health Research, are among those on the committee. Leading specialists in palliative care, pharmacology, and anaesthesia are also on board.
“We have a one-of-a-kind approach,” says Dr. Michael Raymont, CEO of CBD Science. “It’s also influenced by a group of specialists who care about patients and are familiar with the regulatory environment.”
“Others are developing high-grade pharmaceutical [cannabis] goods and hope for a shift in the regulatory landscape.”
“It won’t happen unless the data is seen by groups like NICE.” For patients suffering from cancer pain, we will offer such information for our cannabis medicines.”
The use of cannabidiol (cbd for the treatment of chronic pain) is a company that is currently developing cannabis-derived pain relief for people with cancer.
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