Call for application for a Paediatric Clinical Trial

Purpose and Scope

There is a huge need for more effective, less harmful treatments for children affected by high grade brain tumours. There is currently a lack of clinical trials in paediatric high grade glioma in the UK, and globally, with very few patients given the opportunity to participate in a trial. This is despite advances in research and technology that has led to improvements in the understanding of the biological drivers of different types of high grade gliomas. There are also tools such as molecular profiling that can be used to improve stratification into trials for more targeted therapies.   

The Brain Tumour Charity believes there is an urgent need to translate these findings into new, effective treatments for children with high grade brain tumours. The Charity is also determined to give more children the opportunity to enter into trials of new treatments. We therefore invite applications for funding for a Phase II multi-arm platform study in paediatric high grade glioma in the UK. The study should:

• Comprise a molecularly stratified Phase II multicentre, multi-arm adaptive trial, with the ability to accommodate rapid inclusion of novel interventional arms as they become available
• Utilise the NHS standard of care pathway and provide full molecular sequencing for all participants
• Be restricted to paediatric high grade glioma
• Be open to children, teenagers and young adults less than 25 years of age
• Include measures relevant for future health economic analysis

See ’Proposal Requirements‘ below for further details.

---

Funding

Applicants may apply for research costs of up to £300,000 per year for up to 5 years.

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

• Research Costs as defined in Part A of the guidelines
• 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: https://www.gov.uk/government/publications/guidance-on-attributing-the-costs-of-health-and-social-care-research.

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.

---

Application and Review Process

Complete and submit the application on the Grant Management Portal by 1pm (GMT) Tuesday 31 January 2023. Recommendations for funding will be communicated by May 2023.  

The Brain Tumour Charity is a member of the 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 the 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 Involvement Network (IN) during the development of the proposal and must plan for continued IN input as the trial is run. Details of how to access the IN can be found at:
• https://www.thebrantumourcharity.org/funding-for-brain-tumour-researchers/patient-public-involvement/

Assessment criteria

• The quality and robustness of the trial design.
• The accessibility and acceptability of the trial to the patient population.
• The ability of the trial to increase patient access to novel therapeutics across the UK.
• The ability of the trial to stratify patients based on a molecular diagnosis.
• 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 molecularly stratified Phase II multicentre, multi-arm adaptive trial. The trial should be restricted to children, teenagers and young adults with a paediatric high grade glioma. The trial should outline how successful results, e.g. a clear signal of efficacy, in the Phase II trial are intended to be taken forward to Phase III trial in the future.

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 Involvement Network

The Brain Tumour Charity’s Involvement Network (IN) 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 IN. Details of how to access the IN can be found at: https://www.thebraintumourcharity.org/our-research/for-researchers/patient-public-involvement/
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.

Further essential reading

There are other documents you must read before applying to our grant rounds. These include, but are not limited to Grant Conditions and Finance Guidelines. These documents can be found by following the link below.

---

Further information

If you have any queries please contact us at [email protected] or on 01252 418190.

---