Scientific research and discovery relies on the principles of data sharing. This allows researchers to learn from others work, identify scientific opportunities and work towards the advancement of science. Clinical trials are designed to help test new interventions, so that the community may benefit from it. Dissemination of clinical trial results (whether negative, inconclusive or positive) to the research community, the participants, and the public is a key aspect of conducting a clinical trial. The impact of not sharing the results is detrimental. Allowing data to remain unpublished leads to wastage of resources and time, as ongoing and future researchers cannot benefit from the gathered information. It also results in reporting bias which might misinform the research community.
Information pertaining to clinical trials can be disseminated in the following ways:
- Trial registration: Dissemination of clinical trial results is mandatory to facilitate transparency, accountability and accessibility of trial data. The Indian Council of Medical Research (ICMR) is a signatory of the WHO Joint Statement on Public Disclosure of Results from Clinical Trials, which it adopted in May, 2017. The signatories of this statement agree that prospective registration and timely public disclosure of results from all clinical trials is of critical scientific and ethical importance and that the summary results of trials will be disclosed within one year of trial completion. The Clinical Trials Registry of India (CTRI) is currently developing a structured format for results disclosure for interventional trials. It will cover the following aspects:
- Patient population
- Baseline characteristics
- Primary outcome
- Secondary outcome
- Adverse events
- Final Report or Clinical Study Report
- Sharing of Individual Participant Data (IPD): access to primary datasets facilitates further analysis and the overall research agenda. However, WHO’s joint statement does not include IPD sharing and currently, this is not a mandatory requirement in India. However, there is an increasing acceptance of the need to share (de-identified) IPD. In recent years, various organisations (National Institutes of Health, the European Commission, Organisation for Economic Co-operation and Development) and major research funders (examples include Bill & Melinda Gates Foundation and Wellcome Trust), have supported data sharing, specifically from publicly funded research. Furthermore, as of 1st of July 2018, manuscripts submitted to ICMJE (International Committee of Medical Journal Editors) journals which report clinical trial results, must contain a statement on plans for data sharing. ICJME policies for data sharing and trial registration can be accessed here.
Sharing of results with the research community
Clinical trial results are shared with the research community by publishing details of trial methodology and results, in a peer reviewed scientific journal. The trial protocol must include a publication policy. The CONSORT guidelines have been prepared to improve reporting practices for randomized clinical trials. Increasingly journals will insist that there are adopted and that a CONSORT checklist is completed when a manuscript is submitted. Hence it is recommended that they are followed when trial reports are drafted.
Some other reporting guidelines that are recommended are:
- For meta-analyses of trial data: PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). PRISMA resources (including a statement, checklist, flow diagrams, and an explanation and elaboration paper) are available here.
- For Diagnostic / Prognostic Studies and Clinical Trials: STARD 2015. An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies. (Google Scholar link to access the STARD resources).
The Equator (Enhancing the QUAlity and Transparency Of health Research) Network is a useful resource for browsing reporting guidelines on the basis of the type of trial and study to be conducted. The Equator Network can be accessed here.
Sharing of results with the participants
Informing trial participants of the overall trial results helps acknowledge their contribution to the research. In addition, where appropriate, participants must be given the choice to decide whether they would like their individual results (if they were blinded) returned to them.
References and Further Reading
- Vardhana Rao, M. V., Maulik, M., Gupta, J., Panchal, Y., Juneja, A., Adhikari, T., Pandey, A., Clinical Trials Registry India: An overview and new developments, Indian Journal of Pharmacology, 2018, vol. 50, no. 4, pages 208-211, available online (last accessed on 26.02.2019).
- Joint Statement on Public Disclosure of Results from Clinical Trials, available online (last accessed on 26.02.2019).
- Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).
- CONSORT (CONsolidated Standards Of Reporting Trials) is an evidenced-based minimum set of recommendations for reporting randomized trials, and endorsed by prominent journals. The CONSORT resources can be accessed here.
Resources for Individual Participant Data:
- Ohmann, C., Banzi, R., Canham, S., et al, 2017, Sharing and reuse of individual participant data from clinical trials: principles and recommendations, BMJ Open, volume 7, number 12, doi http://dx.doi.org/10.1136/bmjopen-2017-018647, available online (last accessed on 07.03.2019).
- OECD Principles and Guidelines for Access to Research Data from Public Funding, 2007, Organisation for Economic Co-Operation and Development, available online (last accessed on 07.03.2019).
- Plan for Increasing Access to Scientific Publications and Digital Scientific Data from NIH Funded Scientific Research, National Institutes of Health, February 2015, available online (last accessed on 07.03.2019).
- International Committee of Medical Journal Editors (ICMJE) Recommendations for Clinical Trials (Registration and Data Sharing), available online (last accessed on 07.03.2019).