Funding for clinical trials

Information for grant applicants whose research involves clinical trials.

Clinical trials funded through our biomedical science schemes

We'll consider applications for clinical trials of non-pharmacological interventions. These include:

The clinical trials should be in the UK or Republic of Ireland.

We’ll also consider clinical trials relating to significant health problems in low- and middle-income countries. These are typically funded through major programmes in these countries because they have infrastructures for this purpose.

If you’re thinking about setting up a clinical trial in a low- or middle-income country, you should read our guidance, which will help you with the ethical principles involved, and contains practical advice for developing your proposal.

Clinical trials funded through Innovations

We'll consider trials that are:

and/or

This might be a:

If your trials or clinical evaluations are likely to develop a product for commercialisation, which may need to be carried out overseas, please email innovations@wellcome.ac.uk.

We’ll also consider clinical trials relating to significant health problems in low- and middle-income countries. These are typically funded through major programmes in these countries because they have infrastructures for this purpose.

If you’re thinking about setting up a clinical trial in a low- or middle-income country, you should read our guidance, which will help you with the ethical principles involved, and contains practical advice for developing your proposal.

What grant applicants need to do

Complete our Clinical trials form [DOC 88KB], providing detailed information on the proposed clinical trial, including the study design and the statistical analyses you expect to use. Submit this form with your full application to the Trust.

Create a Trial Steering Committee

If you get a grant from us, you will usually be expected to set up a Trial Steering Committee (TSC). Its purpose is to:

If a TSC is not necessary (eg if the trial is very small), you must still explain how you will monitor the trial.

You need our approval for all proposed members of the TSC. We also expect to have observer status and reserve the right to attend its meetings.

You must send us copies of all reports issued by the TSC. These should reflect on the key issues [DOC 73KB].

If you want to make material changes to the protocol during the course of the trial, these must first be approved by the TSC, and then by us.

If you plan to subcontract any part of the trial to a third party, you must have a formal contract in place before they start work.

Data Monitoring Committee

The TSC may need to set up a Data Monitoring Committee (DMC) to regularly assess and advise on:

The trial sponsor should complete a risk assessment to determine if a DMC is needed and to form one, if required.

If a DMC isn't necessary, you must explain how you will monitor the trial.

Members of the DMC should be independent of both the study management and the TSC.

Registration of clinical trials and public access to findings

You must register the trial. You can do this on any of the following:

When you apply for registration you must state that the trial has been funded by the Wellcome Trust, citing the relevant grant number.

We will meet the costs of registering the trial.

More information and contact details

Read our position statement on clinical trials.

If you have any questions, please email:

sciencegrants@wellcome.ac.uk

innovations@wellcome.ac.uk.