Guidelines for researchers conducting clinical trials

These policies refer to clinical trials as defined by the World Health Organization: ‘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’.

Approvals

Grantholders and administering organisations must have the relevant regulatory and ethical approvals and appropriate governance mechanisms in place before a trial can begin. BHF 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.

BHF is prepared to release a small amount of funding to support the work required to obtain relevant permissions for clinical trials research, including clinical trials authorisation and ethical approvals. You can request funding of up to £50,000 as a separate ‘Clinical Trials Set Up Fund’ budget item when applying for Clinical Study Grant funding. No further funds will be released from the grant until BHF receives a copy of all necessary ethical committee approval(s) and all grant conditions are met. Read our guidelines about releasing funds for clinical trial set up.

Governance

It is BHF policy that a Trial Steering Committee should be set up for all multicentre clinical trials. In addition, for most clinical trials, a Data Monitoring Committee should be established to report to the Trial Steering Committee and to BHF.

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.

Sponsorship and insurance

All trials must have a sponsor/sponsors who can accept the required responsibilities and accountabilities. BHF does not act as a clinical trials sponsor.

A sponsor can be the Chief Investigator’s employing organisation or one of the employing organisations where the trial is located, for example an NHS Trust.

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

Registering a clinical trial

The Health Research Authority (HRA) requires clinical trials – defined as all clinical trials of medicines, devices or another clinical intervention – to be registered on a publicly accessible register as a condition of ethics approval. Clinical trial registration will also become a legal requirement under new UK clinical trial regulations (expected to come into force in early 2026).

Clinical trials of investigational medicinal products (CTIMPs) involving sites in a European Union country must be registered on the European Clinical Trials Database and obtain a EudraCT number as part of regulatory approval from the Medicines and Healthcare Regulatory Agency (MHRA)/European Medicines Agency (EMA).

Any BHF-funded clinical trial must be registered prospectively (before it starts to recruit participants) on:

ISRCTN registry (registry of choice)
Clinicaltrials.gov
Another registry listed on the WHO International Clinical Trials Registry Platform (ICTRP) or the International Committee of Medical Journal Editors (ICMJE) list (if registration with ISRCTN or Clinicaltrials.gov is not possible)

When you register you must:

Include a data sharing plan as part of the trial registration, in line with the 2017 ICMJE requirements on data sharing statements for clinical trials.
Provide a summary of the trial.
State that the trial has been funded by BHF and cite the relevant grant number.
Avoid registering the trial in more than one place, where possible.

We will meet costs associated with registering the trial, which you can request as part of your grant application.

Information about the protocol

BHF expects a summary of the trial protocol and intended analysis plan to be made publicly available prior to the start of recruitment. If sufficient information is provided on the trial registration page, we will consider that registering the trial meets this requirement. As a minimum, we expect the trial registration page to have all mandatory fields completed, include full details of the study population and intervention, a list of endpoints to be assessed and a brief descriptive paragraph about the intended analysis plan (e.g., include whether analysis will be by intention to treat, per protocol in the outcomes field and/or study description).

The Trial Steering Committee should ensure that there are no major deviations from the study protocol. Any subsequent substantial amendments to the protocol must be approved by the TSC and ethics, be notified to BHF and the revised protocol submitted to BHF for approval.

The full trial protocol must be made publicly available within 12 months of primary study completion (defined as the last data collection time point for the last subject for the primary outcome measure). Once available, the full study protocol and analysis plan must also be uploaded to or linked on the registry.

Please note: Before the study starts, the Chief Investigator (or Study Coordinator or Manager) should organise a meeting of the Trial Steering Committee to finalise the protocol, which should then be sent to BHF. A representative of the DMC should attend the meeting to feed into the discussion about finalisation of the protocol. If there have been major changes in the protocol from the awarded BHF grant application, BHF should be informed of these changes for approval.

Updating the registry

All relevant fields of any registry entry must be updated after each substantial protocol amendment or major milestone (e.g. end of vanguard phase, end of recruitment), and must be reviewed annually or sooner until the trial is completed and results have been made publicly available.

Registry records must be updated to include final enrolment numbers achieved and the date of primary study completion (defined as the last data collection time point for the last subject for the primary outcome measure).

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

Note the termination date.
Report the number of participants enrolled on the trial up to the termination date.

You must use the unique registry number in publications and include it in study progress reports.

Please note: BHF monitors whether clinical trials are prospectively registered and whether the registry entry is regularly updated in line with our guidance. See our 2024 review. You will be asked to document when you last updated the registry in all Clinical Study Grant Progress Reports. In your Final Report, you will be asked to confirm that you have a plan in place to update the registry annually or sooner until the clinical trial is completed and all results are publicly available.

Reporting progress

If your clinical trial is supported by a Clinical Study Grant, you will need to submit regular reports (typically every 6-12 months) to BHF outlining the progress of your study, plus a final report within 3 months of the end of your grant. For further information, reporting schedules for other types of BHF grant and example report forms, see Reporting progress.

Making results public

You must make the summary results from your clinical trial (whether neutral, positive or negative) publicly available on the trial registry within 12 months of primary study completion (defined as the last data collection time point for the last subject for the primary outcome measure). Publishing a summary of results within 12 months of the end of the trial will become a legal requirement under new UK clinical trial regulations (expected to come into force in early 2026). For drug trials other than adult phase I trials, this is also an EU regulatory expectation.

We also expect the main findings to be published in a peer-reviewed journal or platform within 24 months of primary study completion. Publications must include the unique trial registry number. Any peer-reviewed publications that arise from BHF funding must be made freely available in line with our open access policy. Research results must be reported in accordance with the recommendations in the CONSORT statement or an alternative reporting guideline.

Data underlying your research publications must be made accessible to other researchers preferably at the time of publication but at the latest 12 months after publication.

The HRA website has useful information about transparency around clinical trials.

Please note: The BHF monitors whether clinical trial results are made available in line with our guidance. See our 2024 review. While we recognise that the timeframe for publishing a study in a peer-reviewed journal is not in the complete control of research team, this should not prevent a summary of results being made publicly available on the registry in a timely manner. Posting results to the registry should not prevent subsequent publication in a journal.

Dissemination of results

Trial findings must disseminated to participants and others involved in the research once results have been made publicly available and if they have said they want to be kept informed. Offering to share trial findings with participants in a timely way and suitable format will also become a legal requirement under new UK clinical trial regulations (expected to come into force in early 2026). See HRA guidance on communicating study findings to participants.

You must also keep BHF up to date with your plans for publishing your clinical trial results so that publicity can be planned when appropriate. When papers resulting from your BHF funded clinical trial are accepted for publication please email the BHF's research communication team as soon as possible to let them know. While your trial is ongoing, the team are also keen to hear about milestones (e.g. xxth participant recruited) as well as participant stories, as these can also be developed into a story for media.

Data management plan

When you apply for funding for a clinical trial, you must include a data management plan as part of your application.

The plan should describe:

Where trial data will be stored in the short, medium and long term.
The type of data to be shared after completion of the trial and when it will be shared.
Example: a fully anonymised version of the dataset used for analysis with individual participant data and a data dictionary will be available for other researchers to apply to use 1 year after publication.
Details of the process for data release.
Example: Written proposals will be assessed by members of the trial steering committee and a decision made about the appropriateness of the use of data. A data sharing agreement will be put in place before any data are share

It should be clear how trial data will be made more widely available, while maintaining the confidentiality and privacy of trial participants, and respecting the terms of consent of participants, and avoiding identification of participants.

BHF expects researchers to follow the guidance in Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials, which outlines good practice principles and practical steps for sharing individual participant data. The sharing of data must be consistent with relevant legal, ethical and regulatory frameworks.