Policy on clinical trials

Clinical trials are an essential step in translating research advances into health innovations and evaluating new interventions.

This policy forms part of our grant conditions, and sets out the requirements for our grantholders before, during and after clinical trials. It should be read alongside our policy on research involving human participants.

1. Definition

Wellcome uses the World Health Organization (WHO) definition of a clinical trial: ‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’.

It includes randomised controlled trials and clinical trials of investigational medicinal products.

2. Funding for clinical trials

We consider applications for clinical trials that could include, but are not limited to, trials:

The funding for clinical trials is through our Science and Innovations schemes.

We recognise that research projects involving clinical trials may require some pre-trial work. We will consider funding for systematic reviews as part of a broader research project.

Wellcome will fund clinical trials in any global region. If your trial is based in a low- or middle-income country, you should read our guidance about this.

3. Pre-trial requirements

Approvals and contracts

Grantholders and administering organisations must have the relevant regulatory and ethical approvals and appropriate governance mechanisms in place before a trial can begin. Wellcome reserves the right to view approvals documentation.

Approvals are not required when you submit your grant application, but you must get these if your funding application is successful.

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.

Sponsorship and insurance

All trials must have a sponsor/sponsors who can accept the responsibilities and accountabilities that go with the role. Wellcome does not act as a clinical trials sponsor.

A sponsor can be:

or

We require information about the sponsor, or sponsors, in your grant application, and you must tell us about any subsequent changes to the sponsorship arrangements.

For all trials, the sponsor is responsible for ensuring there is appropriate insurance.

Registration

All clinical trials that fall within the scope of this policy must be prospectively registered on any of the following:

You must register the clinical trial before the first subject receives the first medical intervention in the trial, in line with the Declaration of Helsinki 2013.

When you register you must:

We will meet the costs associated with registering the trial. You can ask for these as part of your grant application.

If a clinical trial is terminated, you must update the status in the registry to:

Plans and protocols

When you apply for Wellcome funding for a clinical trial, you must submit an outputs management plan with your grant application. This should describe how and when trial data will be made more widely available, while maintaining the confidentiality and privacy of trial participants.

You must make a sufficiently detailed clinical trial protocol and statistical analysis plan (SAP) publicly available. This is to ensure that researchers and other interested parties can interpret the results of your trial.

You must publish the trial protocols and SAPs before trial recruitment is complete. You can use Wellcome Open Research, along with other journals and platforms such as Trials and Protocols.io, to do so.

Standards of care for control groups

Where a healthcare intervention is being examined through a trial, the standard of healthcare provided to a control group subject must be at least equivalent to the best local, currently available and affordable standard of care.

Grantholders, in consultation with ethics committees, are responsible for determining these healthcare standards.

4. Trial requirements

Conduct

All trials must be conducted in accordance with recognised good practice guidelines, for example the UK Policy Framework for Health and Social Care Research. Our good research practice guidelines provide more detailed advice on research design. You must also abide by Wellcome’s policy position on human participants in research.

Governance

Trial Steering Committee

If you receive a grant from Wellcome, you will usually need to set up a Trial Steering Committee (TSC) and tell us about its proposed members. The purpose of the TSC is to:

We expect to have observer status and reserve the right to attend TSC meetings.

If you want to make material changes to the protocol during the trial, these must be approved by the TSC.

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

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

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 necessary.

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.

5. Post-trial requirements

Monitoring

Your research protocol should include any necessary post-research health monitoring related to a volunteer's participation. This is the responsibility of the grantholder.

Wellcome may provide funds for post-research health monitoring where it is an integral part of your research proposal, eg certain long-term drug or vaccine trials.

Grantholders are responsible for complying with any requirements for monitoring of adverse events, at any stage of the research.

Publishing results and making clinical trial data accessible

Grantholders must maximise opportunities to make their research findings freely available. This includes null and negative results.

You must make the summary results from your clinical trial publicly available within 12 months of completing your primary study. These results must be posted to the results section of the clinical trial registry where the trial was originally registered. 

Any peer-reviewed publications that arise from Wellcome funding must be made freely available in line with our open access policy.

Clinical trial data must be managed and shared in accordance with our policy on data, software and materials management and sharing

Data underlying your research publications must be made accessible to other researchers at the time of publication – either openly or via a managed access approach.

Wellcome has joined the ClinicalStudyDataRequest.com portal, which provides managed access to clinical trial data. You are encouraged to list Wellcome-funded trials on this website, and use its independent data access committee to help other researchers gain access to the trial data you collected.

If you fail to comply with this policy, we will consider appropriate sanctions. These may include suspending your grant or not accepting new grant applications from you.

 

6. More information

This policy was updated in May 2018.

Contact us

Contact our information officers if you have a question about our funding policies.