Background
Call opened: October 2018
Call closed: July 2019
This call invited proposals for primary clinical research to evaluate the safety and clinical efficacy or clinical effectiveness of cannabis-based products for medicinal use in humans.
Proposals were eligible that investigated their use for the management of difficult to treat epilepsy, or other disorders unresponsive to existing treatments where there is sufficient existing evidence to justify further, more definitive, research.
Applications should have met all the professional and legal requirements within which cannabis based products for medicinal use may be prescribed and lead to robust clinical evidence that will inform practice (e.g. through randomized controlled trials, though other robust research designs may be appropriate in some circumstances). Applicants needed to show a track record of delivering high quality clinical research and proposals must demonstrate access to the full range of skills needed to undertake the proposed research.
Additional issues of interest included:
- for treatments shown to be efficacious, clarification of therapeutic levels/ appropriate range of dose
- the inclusion of nested mechanistic and pharmacokinetic research (where appropriate)
- reporting of short and longer term (=12 months) adverse events
- clarification of the role of combinations of cannabis derivatives
- the standardisation of therapy and its mode of delivery
- reporting of drug interactions
- reporting of outcomes relevant to carers, immediate relatives or partners
- where relevant, proposals should explain how they would minimise the risk of confounding from the use of cannabis and any derivatives obtained outside the study
Applicants should justify the importance of their proposed research and identify how its findings will contribute to an understanding of the science and potential clinical use of cannabis derived medicines for the treatment of patients.
Participating programmes
The following programmes participated in this themed call:
Efficacy and Mechanism Evaluation (EME)
Health Technology Assessment (HTA)
Funded research
For more information on research funded in this area, please visit NIHR Open Data - cannabis.