Clinical trials policy

Within this definition, Wellcome includes trials designed to:

• test investigational medicinal products
• evaluate safety and other aspects if a new technology requiring regulatory approval (this might be a small molecule/biologic therapeutic, vaccine, cell-based therapy, diagnostic test, digital health technology or medical device)
• test non-pharmacological interventions, for example, behavioural or psychological studies, and changes in the environment of an individual or group
• provide insights into disease pathogenesis, including pharmacological trials
• enhance mechanistic understanding of interventions
• understand and improve health service delivery

Grantholders must integrate sex and gender considerations in their clinical and pre-clinical studies and justify their study design in their application. Trials must recruit a diverse group of participants that, at a minimum, represent the population needing the intervention.  

Meaningful engagement with potential and enrolled participants and their communities should occur before, during, and following the clinical trial. Costs associated with undertaking engaged research activities can be requested in applications. Learn more about Wellcome’s approach to engaged research.  

Trials should be designed and conducted to reduce the emissions and natural resources they use. See Wellcome’s Environmental Sustainability funding policy for more information.

The grant application must say who the sponsor(s) will be. Grantholders must tell us about any subsequent changes to the sponsorship arrangements. 

The sponsor has overall responsibility for the research, including:

• Identifying and addressing quality issues with trial planning, proposals and protocols.
• Ensuring the trial is run by a suitable team, at suitable site/s.
• Ensuring that roles and responsibilities of the parties involved in the research and any delegation by the sponsor of its tasks are agreed and documented.
• Ensuring adequate provision is made for insurance indemnity to cover liabilities which may arise in relation to the design, management and conduct of the research project. Clinical trial insurance can be requested in applications where it is a direct cost of the research.
• Verifying that regulatory and practical arrangements are in place before permitting the research to begin.
• Putting and keeping in place arrangements for adequate finance and management of the trial including competent risk management and data management. 

Relevant regulatory and ethical approvals are not required when grant applications are submitted, but these must be obtained if the funding application is successful. Wellcome reserves the right to view approvals documentation. Approvals must be in place before the first participant is recruited.  

If any part of the trial work is subcontracted to a third party a formal contract must be in place before they start work. 

Governance mechanisms must be in place before the trial begins. Volunteer expenses for people involved in trial governance committees/boards can be requested in applications.  

Trial Steering Committee 

All trials funded by Wellcome should have a Trial Steering Committee (TSC) unless the trial is very small or short, in which case grantholders must tell us how the trial will be monitored.

The purpose of the TSC is to:

• approve the trial protocol before the trial starts
• monitor and supervise the trial’s progress

The TSC Chair and at least half of the committee must be independent of the trial management.  

Grantholders must:

• obtain TSC approval to make material changes to the trial protocol, and tell Wellcome about any material changes
• give Wellcome observer status so a staff member may attend TSC meetings
• send us copies of all meeting papers and reports issued by the TSC

Data and Safety Monitoring Board/Data Monitoring Committee

All trials must be conducted in accordance with recognised good practice guidelines, for example the UK Policy Framework for Health and Social Care Research, and WHO’s guidance for Best Practice for Clinical Trials.  

The trial must also comply with Wellcome’s research involving human participants policy. 

Researchers can use Wellcome Open Research, or other journals and platforms such as Trials and Protocols.io, to publish the trial protocol and SAP. 

Both documents must include the trial registry ID and be linked from (or uploaded to) the trial registry record. Grantholders must confirm this has been done this on their annual progress report. 

Standards of care for control groups 

The standard of healthcare provided to a control group participant 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. 

Interventions that are found to be effective should be made available to the control group where this is feasible. Where treatment costs are not met by other sources, the costs for this can be met by existing grant funds when they are incurred before the grant end date.

The National Institute for Health Research (NIHR) in the UK lists some key characteristics common to several under-served groups:

To ensure health-related interventions are safe and effective for everyone trials must:

• consider recruiting more people from under-served groups than statistically necessary, to improve the quality of the results in relation to those groups

Applicants should demonstrate knowledge of the place and communities they plan to work with. Applications must:

• tell us how your recruitment and retention methods will engage with under-served groups 
• describe and justify your inclusion and exclusion criteria for study participants

Grantholders must ensure the trial protocol includes any necessary post-research health monitoring related to a volunteer's participation.  Funds for post-research health monitoring can be requested in applications where it is an integral part of the research proposal, for example 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. Grantholders must notify Wellcome of trial-related serious adverse events as identified by the Trial Steering Committee (or other trial monitoring mechanism).  

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

Trials must be reported following established guidelines where available, for example, the Consolidated Standards of Reporting Trials -CONSORT- guidelines for randomised trials (reporting guidelines for all study types are available from the EQUATOR network)