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Notice Summary

UK-Southampton: 18/158 EME Themed Call: Cannabis-Based Products for Medicinal Use
GB003ZM277398
National Institute for Health Research
08 November 2018
19 March 2019
Contract Notice - Other
No

Notice Abstract

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.

Notice Details

CONTRACT NOTICE – NATIONAL

SERVICES

1 Authority Details

1.1

Authority Name and Address


National Institute for Health Research

N/A

Southampton


UK

N/A

N/A


N/A

1.2

Address from which documentation may be obtained

As in 1.1

1.3

Completed documents must be returned to:

As in 1.1

2 Contract Details

2.1

Title

18/158 EME Themed Call: Cannabis-Based Products for Medicinal Use

2.2

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.

2.3

Notice Coding and Classification

2.4

Total quantity or scope of tender

3 Conditions for Participation

3.1

Minimum standards and qualification required

4 Administrative Information

4.1

Type of Procedure

The procedure type is unknown.

4.2

Reference number attributed to the notice by the contracting authority

18/158

4.3

Time Limits

   19-03-2019  Time 13:00

4.5

Language or languages in which tenders or requests to participate can be drawn up

EN 

4.6

Tender Submission Postbox

5 Other Information

5.1

Additional Information

Please visit the following portal to view this portal:

https://www.nihr.ac.uk/funding-and-support/funding-opportunities/18158-eme-themed-call-cannabis-based-products-for-medicinal-use/9311

The deadline for applications is 1pm, 19 March 2019.

(MT Ref:277398)

5.2

Additional Documentation

5.3

Publication date of this notice

 08-11-2018