What is the purpose of the clinical trial programme?|
The GW research programme is designed to demonstrate the safety and
efficacy of cannabis-based medicine extracts in the treatment of a variety
of medical conditions. GW has access to a "library" of cannabis plant
varieties that have been bred to exhibit a pre-determined cannabinoid
composition. The trials will assess which of these strains is most
effective in the treatment the different medical conditions that can be
helped by these medicines.|
It is equally important that the medicine is delivered to the patient in
the most effective way acceptable to patients. This is why the programme
will use a variety of delivery methods including inhalers and sub-lingual
sprays under the tongue.
The clinical trials programme is also designed to fulfil the requirements
of the Medicines Control Agency (UK), Food and Drug Administration (US) and
other regulatory authorities around the world. GW is committed to testing
and demonstrating the safety and efficacy of its products using research
that meets the highest standards of Good Clinical Practice.
What clinical trials are already underway or planned?|
The first trials involving patients will begin in the next few months in
the UK. These trials will use the n-of-1 methodology with patients
receiving a different test preparation in each period of the study. During
the course of the trial each patient will be given a placebo and several
active test preparations and the effects of each on their medical condition
monitored. If one or more of the active preparations result in an
improvement in health the patient can then choose to continue to receive an
active preparation as part of a long term safety study.|
This trial design meets our moral obligation to patients so that they can
benefit from cannabis-based medicines as quickly as possible and will
provide essential information which will be used to design larger group
studies. In addition to the UK we are planning to undertake an
international clinical trials programme.
Keep updated on what's happening in cannabis research by visiting the news area.
The use of cannabis, even for medical purposes, is illegal. All research as
part of the UK Medicinal Cannabis Project is carried out under government
licences. The Project does not condone or encourage the use of cannabis
outside approved clinical trials.