Policy position on clinical trials
We recognise that clinical trials constitute an essential step in translating biomedical advances into healthcare improvements, and that they remain the safest and most effective way to evaluate new treatments and interventions.
We support clinical trials as a key component of our vision to achieve improvements in health and believe that the highest standards should be maintained during trial planning, design and conduct.
Definitions and scope
The World Health Organization defines a clinical trial as: "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. Interventions include, but are not restricted to, drugs, cells and other biological products, surgical procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc."
This policy covers clinical trials as defined above, including randomised controlled trials (RCTs) and Clinical Trials of Investigational Medical Products (CTIMPS).
Implementation and the Wellcome Trust’s expectations of grantholders
Funding for clinical trials
Funding applications for high-quality clinical trials will be considered through our Science or Innovations Divisions. In the context of our Science programmes, we will consider funding applications for pharmacological trials that may provide insight into disease pathogenesis, and non-pharmacological interventions such as behavioural and psychological studies, where these are to be conducted in the UK and the Republic of Ireland.
We will also consider proposals for trials relating to health problems of significance in low- and middle-income countries (see also our guidance notes on research involving people living in low- and middle-income countries).
Our Innovations Division will consider applications to support trials worldwide of new technologies to advance them to the point where they become attractive for further development by the medical, pharmaceutical or biotechnology industries, such as drugs, vaccines, cell-based therapies, diagnostic tests or medical devices.
We require researchers to have the relevant regulatory and ethical approvals and appropriate governance mechanisms in place before any trial can begin, although researchers may apply for funding prior to this.
In the event of an award being made, commencement of a trial would be subject to these approvals and governance structures being in place.
We do not require sight of approval documents when they are obtained, but we reserve the right to see relevant approval documents at any point during the lifetime of the grant.
We recognise that research projects involving clinical trials require a degree of pre-trial work. We will consider supporting systematic reviews as part of a broader research project, when it is deemed appropriate.
Standards of care for control groups
Where a healthcare intervention is being examined as part of research, the standard of healthcare provided to a control group member must be at least equivalent to the best local, currently available and affordable standard of care.
Principal investigators, in consultation with ethics committees, are responsible for determining these healthcare standards, which should be outlined in grant applications as part of the description of the experimental design.
We expect the research protocol to include proposals for any necessary post-research health monitoring related to a volunteer's participation and consider this a responsibility of the principal investigator.
We may provide funds for post-research health monitoring where it is an integral part of the research proposal and informs the research answer. For example, certain long-term drug or vaccine trials may require such monitoring.
Principal investigators are responsible for complying with any requirements on the monitoring of adverse events, at any stage of the research.
Access to interventions demonstrated to be effective
We do not fund healthcare per se and the financial responsibility of providing successful interventions after research is over falls outside of our remit. We do, however, encourage grant applicants to consider how post-research access could be ensured. This may require the instigation of discussions with different stakeholders prior to the research being carried out. Where appropriate to our role as a research funder, we may assist with such processes.
We recognise that in some cases it may be difficult to estimate with any degree of accuracy how financially or logistically feasible it would be for a successful intervention to become available to patients. We will therefore take such difficulties into account when making funding decisions.
We recognise the importance of maintaining rigorous standards of trial management and, as such, requires all trials to be conducted in accordance with the MRC Guidelines for Good Clinical Practice in Clinical Trials. We also expect researchers to abide by our policy position on human participants in research.
Post-award governance framework for trials
Trials funded through our Science programmes are subject to our post-award governance framework, which sets out our requirements of grantholders. The key requirements are that a Trial Steering Committee (TSC) should be constituted and that we should approve its membership, be given observer status on the TSC and retain the right to attend its meetings (see further details of the post-award governance framework).
Trials funded through our Innovations Division are subject to similar overarching principles, specified in the governance guidelines incorporated into individual funding agreements.
All trials are required to have a sponsor(s) who is in a position to accept the responsibilities and accountabilities associated with this role. The Department of Health Research Governance Framework for Health and Social Care defines the sponsor as the "individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study" – this may be the employing organisation or one of the employing organisations where the trial is located, such as an NHS Trust, a pharmaceutical company or a university (see sections 3.8 and 4.3 of the Framework for more information).
We will not act as a sponsor for clinical trials. However, we require information about the sponsor(s) and should be kept informed of any subsequent changes made to the sponsorship arrangements.
For all trials, the sponsor is responsible for ensuring that appropriate insurance is in place, and we reserve the right to see the relevant documents on request.
We require all clinical trials that fall within the above-defined scope of this policy to be registered on ClinicalTrials.gov, on the ISRCTN registry, or on another register listed on the WHO International Clinical Trials Registry Platform (ICTRP).
Summary details of the trial will need to be provided for registration and you should indicate on your application for registration that the trial has been funded by the Wellcome Trust, citing the relevant grant number. We will meet the costs of trial registration, and researchers may request such costs as part of the grant application.
Transparency and publication of results
We believe that making the outputs of Wellcome-funded research available to the widest possible audience is a fundamental part of our mission. We therefore support unrestricted access to the published outputs of research, and expect researchers to maximise opportunities to make their research findings freely available, including negative results.
Publication of clinical trial data
We encourage all Wellcome-funded researchers to maximise access to research data with as few restrictions as possible, and clinical trials should not be seen as an exception. It is essential, however, to ensure that the confidentiality of those involved in clinical trials is maintained, and that safeguards are in place to ensure personal identifiable information is protected. Researchers are encouraged to explore opportunities to make anonymised patient-level data available where appropriate.
We recognise that making data more accessible does not necessarily make it more assessable: releasing large amounts of data without appropriate curation may not be the best basis for effective scrutiny and re-use. Independent stakeholders must be able to scrutinise the data from clinical trials in detail. We therefore encourage all stakeholders – researchers, funders, industry, publishers, and patient groups – to work together to develop practical solutions to facilitate the effective disclosure of clinical trial data.
We support a proportionate approach to the development and implementation of legislation and best practice guidance governing clinical trials in order to achieve a regulatory environment in which research can be conducted effectively.
Information about which approvals are needed for CTIMPS can be found using the Clinical Trials Tool Kit.
To discuss this issue further, email the Strategic Planning and Policy Unit: firstname.lastname@example.org
If you have questions about any of our policies, contact the policy team.