Description of the goods or services required
The EME Programme are participating in the Themed Call: cannabis-based products for medicinal use.
•18/158 EME Themed Call: cannabis-based products for medicinal use
This National Institute for Health Research (NIHR) call welcomes proposals for primary clinical research to evaluate the safety and clinical efficacy or clinical effectiveness of cannabis-based products for medicinal use in humans.1
Proposals are eligible that investigate 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 meet 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 will need 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 include:
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.