Funding for clinical trials
Funding applications for high-quality clinical trials will be considered by our Science Funding or Technology Transfer divisions.
The Wellcome Trust will consider proposals for trials of non-pharmacological interventions - for example, behavioural or psychological studies, and those pharmacological trials that may provide insight into disease pathogenesis - to be performed in the UK and the Republic of Ireland.
The Trust will also consider clinical trials relating to health problems of significance in low- and middle-income countries. Such trials may, for example:
- investigate new or existing interventions against diseases or health problems that are largely restricted to low- and middle-income countries (e.g. malaria)
- test interventions suitable for resource-poor settings against diseases that also occur in higher-income regions (e.g. low-cost treatments against stroke or tuberculosis)
- include those supported through the global health trials scheme. This initiative, from the Trust, the Medical Research Council and the UK Department for International Development, provides support for late-stage trials of interventions that will help improve health in low- and middle-income countries.
It is anticipated that most large trials will be funded through major programmes in low- and middle-income countries that have well-developed infrastructures for this purpose.
The Trust has issued a position statement on ethical principles to inform and guide applicants proposing research involving people living in low- and middle-income countries. Applicants are advised to take this document into consideration when developing any proposal undertaken in a low- or middle-income country.
Initial enquiries should be emailed to the relevant Science Funding stream.
Requirements for grant applicants
Applicants for funding opportunities (other than the Investigator Awards scheme) are required to provide detailed information on the proposed clinical trial, including the study design and the proposed statistical analyses to be employed, using the Trust's additional information for clinical trialists’ form [Word 116KB]. This information should be submitted to the Trust with the full application.
Investigator Award applicants will not be required to provide the above detailed information with their main application, but will be asked to supply it once the study design has been finalised. Moreover, the Trust will require confirmation that the trial protocol has been approved, typically by the Trial Steering Committee (TSC), in advance of the funds being used in association with a trial, and awardees will be expected to comply with the post-award governance framework described below.
Trust's expectation of grantholders
The Trust has established a post-award governance framework for the clinical trialists that it supports, and the following is expected of grantholders:
- For any clinical trial of an appreciable size, the Trust would normally expect a TSC to be established. As a minimum, the TSC should be expected to meet annually, and will be required to agree the trial protocol and monitor and supervise the progress of the trial. If a TSC is not appropriate, then the Trust will need to be assured that an appropriate strategy for the monitoring of the trial has been implemented.
- The Trust requires grantholders to seek its approval on the membership of a TSC. Furthermore, the Trust would expect to be afforded observer status on the TSC, and to reserve the right to attend its meetings.
- Copies of the reports of the TSC should be forwarded to the Trust for review. These reports should reflect on the key issues surrounding the delivery of the trial [Word 73KB].
- The Trust should be informed of any material changes to the protocol during the course of the trial. Such changes should normally be approved by a TSC. The Trust will then consider approving these changes.
- It is a condition of award that where a Trust-funded clinical trial involves activities to be undertaken by a third party, the host organisation should ensure that a formal contract with the third party is in place prior to any such activity being carried out.
Technology Transfer at the Wellcome Trust will consider trials that are designed to provide proof of concept and/or evaluate safety and other aspects of a new technology requiring regulatory approval. This might be a drug, vaccine, cell-based therapy, diagnostic test or medical device. Trials or clinical evaluations intended to develop a product for commercialisation (these may be conducted overseas if appropriate) should also be referred to Technology Transfer.
Initial enquiries should be emailed to Technology Transfer: firstname.lastname@example.org.
The Medicines for Human Use (Clinical Trials) Regulations 2004, which implement the EU Clinical Trials Directive and apply to clinical trials of investigational medicinal products, require applicants to identify a sponsor who is in a position to accept the responsibilities and accountabilities associated with assuming this role.
The Department of Health Research Governance Framework for Health and Social Care [PDF 218KB] (RGF) defines the sponsor as the "individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study".
The sponsor role is typically undertaken by the host organisations, or one of the host organisations, where the trial is located - for example, an NHS Trust or a university.
Please note that the Wellcome Trust considers that it is not appropriate for it to act as a sponsor for clinical trials as defined by the Medicines for Human Use (Clinical Trials) Regulations 2004 and the RGF.
The Trust recognises the importance of maintaining rigorous standards of trials management and, as such, advises applicants to follow the Medical Research Council’s Guidelines for Good Clinical Practice in Clinical Trials.
It is a requirement of the Wellcome Trust that all randomised controlled trials that it has funded are assigned an International Standard Randomised Controlled Number (ISRCTN). The application process is detailed on the Current Controlled Trials (CCT) website.
Once an ISRCTN has been assigned, trials will automatically be registered on the Trust’s own clinical trials register. This register was launched in 2006 and is hosted on the CCT metaRegister of Controlled Trials (mRCT). Details of more than 200 trials are now available for public viewing.
Pooling this register with other major international registers will enable visitors to the site to search all of these in a 'one-stop' environment.
In 2004, the International Committee of Medical Journal Editors (ICMJE) gave notice that it would consider a clinical trial for publication only if it had been registered in an appropriate registry. In May 2005, the ICMJE confirmed that this policy would take effect for new clinical trials from 1 July 2005 and for ongoing trials from 13 September 2005.
The Department of Health, the Medical Research Council and the Wellcome Trust regard the registers hosted on the CCT metaRegister of Controlled Trials as appropriate for the ICMJE's purposes. The registers run to ICMJE criteria and they will be aligned with World Health Organization standards when agreed. CCT has placed its system of unique identifiers, the ISRCTN Register, in a not-for-profit structure to comply with the ICMJE's criteria.
For further information, see the Department of Health website.
Initial enquiries for clinical trials supported through the biomedical science funding programmes should be emailed to the relevant Science Funding stream:
- Immunology and Infectious Disease - email@example.com
- Populations and Public Health - firstname.lastname@example.org
- Neuroscience and Mental Health - email@example.com
- Physiological Sciences - firstname.lastname@example.org
- Molecules, Genes and Cells - email@example.com
Initial enquiries for clinical trials supported by Technology Transfer should be emailed to firstname.lastname@example.org.