Using real world evidence in medical cannabis
By Mike Morgan-Giles, CEO, Cannabis Industry Council
The challenges of developing extensive clinical trials for cannabis are well known within the industry, but perhaps less so among policy makers, regulators, and even doctors on the periphery.
A range of factors contribute to this, including high start-up costs, complex and somewhat illogical regulations, and the need to prioritise (often desperate) patient needs over the use of placebos in wider trials.
Combine this state of affairs with the fact that applying a pharmaceutical approach to a whole plant medicine is akin to attempting to put a round peg in a square hole, and it becomes clear we need a more thoughtful and nuanced approach.
Furthermore, cannabis has been around for hundreds of years and has a known safety profile. Its benefits as a medicine far outweigh any potential negatives, but unfortunately some politicians and sceptics have fed a false, counter narrative for far too long.
This makes cannabis fundamentally different from other drugs – especially those produced in laboratories for the first time, with little to nothing known about any potential side effects or indeed patient outcomes over the short or long term.
But there is a way forward.
There are an increasing number of patients using cannabis medicinally who have reported at times remarkable improvements in their physical and mental well-being from the plant.
These range from children with specific conditions such as epilepsy, to those in long term pain who have exhausted all other options, to the elderly with conditions such as multiple sclerosis or glaucoma.
There is even evidence that using cannabis-based medicinal products can help those with cancer live a more fulfilling life while managing their condition.
A more pragmatic approach would mean using these patient stories and observational and other trials, as real world evidence within the scientific assessment of cannabis as a viable medicine.
This approach is discussed in a new research paper called ‘The value of real world evidence: the case of medical cannabis‘, produced by Drug Science.
The Cannabis Industry Council strongly supports this vital report into the use of real world evidence, and hopes the medical profession and regulators will engage with such an approach.