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Cannabinoid clinical trial

There is considerable interest in both the lay and scientific community relating to the activity of cannabinoids in brain tumours with the view that cannabinoid-based products not only help to relieve the symptoms of a brain tumour but also have a positive impact on survival.

Purpose and Scope

To date, the scientific evidence for a role of cannabinoids in the control of brain tumour growth is mounting but not conclusive.

We invite applications for funding to study the clinical efficacy of cannabinoids in the treatment of high-grade glioma tumour types. The study should:

  • Comprise a Phase II or Phase III multi-centre, double-blind, placebo-controlled trial
  • Utilise the Tessa Jowell BRAIN MATRIX infrastructure
  • Be restricted to high-grade tumour types
  • Be open to patients aged 16 years old or older
  • Be compatible with enrolling patients into the BRIAN App and use this to record (as a minimum) patient-reported Quality of Life using the EORTC QLQ-C30 and other tools as required
  • Include measures relevant for future health economic analysis

Funding

Funding of up to £150,000 per year for up to 3 years can be requested.

The budget should be developed in line with the AcoRD guidelines. Payment will be made on a per participant basis. It should cover:

  • Research Costs as defined in Part A
  • NHS Support Costs
  • NHS Treatment Costs

Clinical Research Nurse costs may not be included as CRN time should be available within the centre and covered by NIHR. In preparing the budget, applicants should be aware of the AcoRD guidance. As an Association of Medical Research Charities (AMRC) member charity, we expect any research costs identified as ‘Part B’ (i.e. local study trial co-ordination or data collection) that are carried out by existing staff employed by the NHS, NIHR Clinical Research Network (NIHR CRN) or other clinical organisations to be paid by the Department of Health and Social Care through local networks or the NHS trust. They will not be paid by AMRC charities. Guidance can be found at on the gov.uk website.

The grant will be awarded to the Lead Applicant’s institution. Funding can be allocated to co-applicant institutions with agreements put in place between all partner institutions. Please note that The Brain Tumour Charity intends to use crowdfunding mechanisms to fund this research. If an application is recommended for funding by the Scientific Advisory Board (SAB) and Trustees, we will begin a crowdfunding campaign. The award will only be made once sufficient funds have been raised.

Application and Review Process

Complete and submit the application on the Grant Management Portal by 5pm (GMT) Wednesday 10 February 2021. Recommendations for funding will be communicated by May 2021.

The Brain Tumour Charity is a member of the Association of Medical Research Charities (AMRC) and all applications will undergo peer review in line with AMRC principles. Applicants will have the opportunity to respond to peer review comments prior to the application being considered for funding by our Scientific Advisory Board (SAB).

The Charity requires annual progress reports from all grant-holders and annual completion of a Researchfish submission during and after the grant period.

Eligibility Criteria

  • The award is open to applications from UK-based universities, NHS sites or other recognised UK higher research institutions.
  • The trial must be co-ordinated by a lead clinical trials unit (CTU). Experience of co-ordinating multi-centre brain tumour trials will be looked upon favourably.
  • Clinical investigators should have a contract of employment with the host institution that exceeds the planned finish date of the research by at least 12 months.
  • A CTU may lead on only one application.
  • Applicants must consult The Brain Tumour Charity’s Research Involvement Network (RIN) during the development of the proposal and must plan for continued RIN input as the trial is run. Find out how to access the RIN.

Assessment criteria

  • The quality and robustness of the trial design.
  • The accessibility and acceptability of the trial to the patient population.
  • The potential of the trial to produce a statistically-definitive answer to the research question.

Proposal Requirements

Trial design

The planned trial must be a multicentre, double-blind, placebo-controlled trial. The trial should be restricted to people who have a high-grade glioma tumour type (grades 3 and/or 4). The trial must be able to expand to a Phase III trial, if data allow, and should specify the stop/criteria that must be met to enable this.

Trial data

Trial data must be stored in a dedicated trial database which has the ability to facilitate straightforward data transfer to The Charity’s BRIAN databank (see below). The CTU will agree to a data sharing agreement to facilitate this transfer and further use of the data. Applications using the BRIAN databank to collect the trial data will be strongly favoured.

Working with The Brain Tumour Charity

The Brain Tumour Charity has launched a brain tumour databank, BRIAN. While databank participation will not be compulsory for trial participants, participants must be informed of the option during the consent process, and trial data collection must be in a format which enables straightforward transfer of trial data to the databank for trial participants who opt-in to data sharing. Trial participants who opt-in will have their NHS data shared with the databank straight away, and their trial data must be shared with the databank promptly after the relevant trial outcomes have been released.

The successful applicants must undertake to work with The Charity to provide The Charity’s support information to all potential participants during the consultation for entry.

Consultation with NCRI and NIHR

The advice and guidance of the NCRI Brain Group should be sought during the design and generation of any application. The local NIHR Clinical Research Network should be consulted during the development of the application for advice and guidance on trial set-up, design and delivery.

Performance Metrics

Applicants must suggest SMART performance metrics against which the performance of each trial centre could be judged, and how they expect to perform against each metric in each year of funding. Metrics should include, but not be limited to, recruitment numbers.

Consultation with Research Involvement Network

The Brain Tumour Charity’s Research Involvement Network (RIN) must be consulted during design and development of the application and should support the Public and Patient Involvement (PPI) throughout the trial. The application must set out plans for ongoing PPI, including the RIN. Find out how to access the RIN.

Patients and the public must be involved throughout development of the application, trial delivery and during dissemination of the results. Applicants will be required to detail their plans for PPI which may include, but should not be limited to, a Patient Steering or Advisory Group, a patient representative as part of the team (e.g. PPI Co-applicant) and plans to share results with patient groups and the general public.

Key Dates:

  • Applications must be submitted by 5pm GMT Wednesday 10 February 2021
  • Recommendations for funding will be communicated by May 2021

Apply now

Further information

If you would like to discuss project ideas or require any additional information, please contact the Research Team.
E-mail: research@thebraintumourcharity.org
Phone: +44 (0) 1252 418190