Alzheimer’s Research UK - Global Clinical Trials Fund Expression of Interest form

This Expression of Interest proforma should be completed in Word format and submitted electronically as a PDF email attachment to before 5pm on deadline day.Please attach applicant and co-applicant CVs(but not collaborator CVs) using the template at the end of this proforma.

The document length (excluding CVs) should be no more than ten sides of A4 (Arial 11, single spacing).

For more information visit contact the Research Team ().

Title

Trial logistics and management

Lead applicant

Name
Post held
Department
Institution
Email address
Telephone number

Co-applicant(s)

Name / Affiliation / Email address

Collaborator(s)

Name / Affiliation

Co-applicant or collaborator statistician(s)

Name / Affiliation / Email address

Sponsor (please include address)

Trial site(s). Please describe relevant facilities available on-site.

How will the trial be managed and what experience does the team have of managing similar trials? Describethe local research governance structure and include plans for ethical approval and trial registration.List the trial management unit(s) or similar organisations that are involved, if applicable.UK applicants are advised to review all avenues of support including local clinical trial units, UKCRN or similar organisations.

Please describe whether Contract Research Organisations will be involved in the trial and in what capacity.

Timeline

Proposed duration of award
Anticipated duration of trial set-up period
Anticipated ethical approval date
Anticipated approval date from other regulatory bodies
Anticipated trial start date
Anticipated recruitment start date
Anticipated trial end date

Budget

ARUK will fund clinical trials wholly or partly as well as provide conditional financial support with other funders.

What is the grant value sought from ARUK? Please provide a breakdown.

Staff / £
Consumables and other costs directly attributable to the project / £
Equipment / £
Travel and subsistence / £
Total / £

If you are seeking a conditional commitment from ARUK prior to submission to another funder, please provide details of funding sought to both organisations and the expected date of submission to the other funder. Anyagreed commitment from ARUK would be dependent on an award by the other funder.

Are there other key partners involved in terms of funding support (e.g. from other funding agencies, pharmaceutical companies or other)? Please provide details of funding arrangements agreed or under consideration including expected dates of result and information on ongoing review processes. If appropriate, ARUK will liaise with other potential funders to avoid duplication of processes.

Are there other key partners providing support in terms of expertise, reagents or technology (e.g. pharmaceutical companies or other)? Please provide details of these contributions and how these will add value to the clinical trial.

For UK applicants with non-commercial studies taking place in the National Health Service (NHS) only:
ARUK is a NationalInstitute for Health Research non-commercial partner and therefore the Department of Health could meet some of the costs of ARUK-funded research in the NHS. This is set out by the AcoRD guidelines ( If the trial is proposed to be conducted within the NHS, please provide an estimated breakdown of research, NHS support, NHS treatment and excess treatment costs and describe how the NHS treatment and support costs have been calculated.

Research costs
NHS Support
NHS Treatment
Excess Treatment

Background and objectives

What is the intervention? For drug-based interventions, please detail the name, origin, type of compound and the proposed mechanism of action, if known.

What are the objectives and the purpose of the trial?Briefly discuss the therapeutic hypothesis to be tested in the trial and provide context in relation to findings from preclinical studies that potentially have clinical significance and from clinical studies that are relevant to the proposal. Describe how the proposed trial will differ from or complement any relevant planned, ongoing or recently completed trials elsewhere in the UK or internationally.

Trial design and feasibility

Type of trial (e.g. Phase I, Phase II, complex intervention)
Design of trial to be conducted (e.g. double-blind, placebo-controlled)
Is the investigational agent or intervention being provided by a company?
Has the investigational agent or intervention been approved by any regulatory authority?
Does it already have any Marketing Authorisations in this, or any other indication? If so, please name MA Holder with dates.

How is the intervention going to be delivered or administered? Include both experimental and control/comparator interventions. If applicable, please detail the route of administration, dosage, dosage regimen, and treatment period(s).

Provide a summarised description of the trial population, including the number of subjects,the duration of their participation,recruitment strategies and the anticipated dropout rate.

Provide a summarised description of the primary endpoints and the secondary endpoints and how these will be measured during the trial.Justify the number of subjects proposed for each endpoint with power calculations.

Future plans

What impact will the results have on clinical practice, or our understanding of the proposed intervention or dementia, and how does it compare to existing practice?

List of key relevant references

CV Template

Name

Title

Affiliation

Address

Email

Telephone

Fax

Mobile

Degree/qualification

Year / Qualification / Awarding Body

Employment record

From / To / Job Title / Employer

Key publications

Current grants and contracts

Title and funding organisation / Start date / End date

Scientific career details

Other relevant details