How can charities support clinical research transparency?

Open research > Registering and reporting clinical research

Various actors have produced best practice guidance for clinical research transparency, often focused on clinical trials. This has been collated in the guidance below. Charities can implement a few or all these recommendations, and over time, on charities’ own paths to improving the transparency of their research.

Ask the researchers you fund to do the following. You can do this semi-formally (e.g. through communications) or utilise formal mechanisms such as developing a policy or updating your terms and conditions.

Register clinical trials (any phase) in a publicly available, free to access, searchable clinical trial registry which complies with WHO’s international agreed standards (unless a deferral is agreed by or on behalf of the research ethics committee), following the WHO guidance on the minimum amount of trial information that must appear in a register. Wherever possible, register all clinical studies.
Make the initial study protocol publicly available at the time of registration and ensure this is updated (including amendments approved by ethics committees) within 12 months of primary study completion.
Make sure that the content of the clinical trial protocol reaches the minimum standards laid out by the SPIRIT 2013 Statement.
Retain research outputs (findings, data, and tissue) and make these publicly accessible, with adequate consent and privacy safeguards, in a timely manner after the study/trial is completed by:
- communicating these, in an accessible format, directly to the research participants
- posting trial/study results to the results section of the trial/research registry within 12 months of study completion
- publishing results through an open access journal publication within 24 months of study completion
- the inclusion of a plan for the public disclosure of results, including timebound commitments at the time of grant submission
Ensure that the results summary/report/paper describes study design, methods and results, including statistical analysis, in a manner that is clear and transparent to both professional and lay readers.
Ensure trial and grant IDs are included in all publications and the abstract is published on PubMed and other bibliographic search databases.

You could consider earlier transparency behaviour, or compliance with transparency requirements (such as those listed above), as a factor when making decisions on future funding applications. To facilitate this and provide an additional prompt/encouragement to adjust transparency behaviour you could monitor the registration of your funded research. If not discoverable, ask the team supported by the charity to register the study. You could, if deemed appropriate, make the outcomes of this monitoring process public.

Definitions

Clinical Trial: A clinical trial compares the effects of one treatment, preventative intervention or diagnostic test with either another, or a control (no treatment/test). According to the HRA, clinical trials include: a clinical trial of an investigational medicinal product, a clinical investigation or other study of a medical device, a combined trial of an investigational medicinal product and investigational medical device, any other trial to study a novel intervention of randomised clinical trial to compare interventions in clinical practice e.g. trials of surgical interventions, radiotherapy, imaging, mental health investigations/therapies, physiological investigations, trials of non-medicinal products or devices or complimentary/alternative therapies.

Read the full list on our definitions page.

what is trial registration and where do people go for it?

what is required in results reporting?

Registering and reporting clinical research