Open research data: clinical trials and public health interventions
The MRC strongly promotes the principles of open research data and aims to make the research process and findings as open, understandable and reproducible as possible. Sharing data can enhance the use of existing data, avoid duplication of research effort and stimulate new discoveries.
The MRC policy on open research data from clinical trials and public health interventions applies to the following types of MRC-funded study:
- Clinical trials and clinical intervention studies: studies that prospectively assign human participants to one or more health-related intervention to evaluate the effects on health outcomes, including all stages of clinical trials.
- Public health intervention studies: studies of a public health intervention to promote or protect health, or prevent ill-health, in communities or populations.
- Observational studies: studies that assess outcomes in groups of human participants according to a research protocol, in order to investigate the effects of lifestyle or behaviours, or interventions that are part of routine care.
The policy does not apply to studies that involve human tissue only. For applicable studies funded through the MRC Developmental Pathway Funding Scheme (DPFS), this policy is additional to DPFS monitoring requirements.
Any MRC-funded studies within the scope of this policy are required to register with the ISRCTN registry. The MRC project reference must be included in the registration. Any registry entry should be regularly reviewed (at least annually) and updated with any changes until the trial is completed and findings made public.
Clinical Trials of Investigational Medicinal Products (CTIMPs) must register on the EU Clinical Trials Register (EUCTR) and trial results must be posted on the EUCTR within 12 months of completion. Investigators who register a trial that is funded or sponsored by the MRC must comply with this requirement. The EUCTR entry should be regularly reviewed (at least annually) and updated.
Studies funded through the DPFS may defer registration until the completion of preclinical research.
The MRC will cover the cost of ISRCTN registration where this has been included in the application for funding. The ISRCTN number should be provided in the annual project update to the MRC via Researchfish® within 12 months of the study commencing.
Publishing study findings
The MRC requires the results from MRC-funded studies (whether positive or negative) to be published, or made publicly available, without unreasonable delay following the conclusion of the study. The MRC is a co-signatory to the WHO Joint statement on public disclosure of results from clinical trials (2017), which supports the timely public disclosure of results from all clinical trials.
Publications should include the MRC project reference and ISRCTN registration number.
Publishing the study protocol and statistical analyses
The MRC requires all funded studies to make the study protocol, analysis plan and all relevant statistical analyses publicly available prior to the start of the study. Details of where and how the study protocol and analysis plan may be accessed should also be provided on the ISRCTN register.
Data sharing: Individual Participant Data
The MRC expects valuable data arising from MRC-funded research to be made available to the scientific community with as few restrictions as possible so as to maximise the value of the data for research and for eventual patient and public benefit. Such data must be shared in a timely and responsible manner.
The MRC is aware of the risks of fully open access to individual participant data (IPD), in particular the need to comply with participant consent and avoid inadvertent or deliberate identification of participants. The MRC expects researchers to follow the guidance in Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials which details good practice principles and practical guidance on sharing IPD in a controlled way. A data sharing policy should be developed for each study.
Research involving the population health sciences, and population and patient cohorts should follow the MRC policy on sharing of research data from population and patient studies.
The MRC expects researchers to publish summary data about the data requests made, including the number of requests fulfilled and reasons for refusal.
Further discussion of this policy is provided in: Data Sharing from Clinical Trials — A Research Funder’s Perspective. The MRC has also contributed to the development of the European consensus guidance Sharing and reuse of individual participant data from clinical trials: principles and recommendations.
Applications for MRC funding for clinical and public health intervention studies should include the costs of data curation, including the preparation of metadata, access management and data release, to support its availability for data-sharing and re-use.
Secondary use of data
This policy also applies to secondary users of data from MRC-funded clinical and public health intervention studies.
Secondary data analyses should not be registered as separate clinical trials on the ISRCTN, but it is considered good practice to make information about such studies available on a publicly accessible register. Researchers are required to include a reference or link to the original data and trial registration number with any published findings.
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