![]() ![]() The HRA web pages also provide guidance on the communication of research outcomes to participants. INVOLVE, the national advisory group supporting public involvement in NHS, has produced Public Involvement in Research: Impact on Ethical Aspects of Research (PDF, 528 KB). Patient and public involvement may help to guide this process. It is important to establish whether a participant will want to be actively informed of trial results, or whether they would like the onus to be left with them to obtain the results. Informing participants of results acknowledges their contribution, shows respect and sees them not simply as a means to the researchers’ ends. The International Committee of Medical Journal Editors (ICMJE) members simultaneously published an editorial on Sharing Clinical Trials Data that outlines proposed new requirements for authors to comply with mandatory data-sharing practices. This guidance summarises the good clinical practice principles to follow when sharing individual participant data using a controlled access system. ![]() Guidance on the Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials, has been produced for publicly funded clinical trials. The sharing of the data produced in a clinical trial has the potential to provide benefits to patients and the scientific community. The NIHR Journals Library will help disseminate the findings of the research commissioned by these programmes and will provide an important permanent and comprehensive record of the work which has been funded. Authors will be required to report the nature of patient/public involvement in their study and to produce a clear ‘plain English’ summary within their report so that the findings are widely accessible. For non-commercial trials, it is strongly recommended that the CONSORT guidelines are followed when preparing final study reports.įinal reports of studies funded by a number of NIHR programmes will be published as part of the NIHR Journals Library and its guidance for authors must be followed. There are undeclared changes from the study protocolĬONSORT is an initiative that was developed to improve the reporting of randomised controlled trials, enabling readers to understand a trial's design, conduct, analysis and interpretation and to assess the validity of its results.The interpretation of results is misleading.Method or findings have been subject to selective reporting.Key information relating to methods and results is missing, incomplete or ambiguous.Presented in a way that allows inclusion in future systematic reviews.Characteristics of good and poor reporting practices are described below: Good Reporting Practice: The common route to inform the research community of full trial methods and results is through publication in peer-reviewed scientific journals however many publications have documented deficiencies in the reporting of clinical trials. The ethics application form requires the applicant to confirm how they intend to report and disseminate their results. Information concerning publication policy should be included in the protocol and funders will often ensure plans are in place. Individual Participant Data: Sharing with others, de-identified individual-participant data (IPD).A Final Study Report: Providing full details about the trial’s methods and results.A Summary of Results: Providing results for pre-specified primary and secondary end points, details of adverse events and statistical analyses (see Clinical Trial Summary Report station).Trial Registration: Providing information about planned clinical trials (see Unique Trial Number station). ![]() Information about clinical trials is disseminated in the following ways: Dissemination of Results is good practice and is relevant to all trials. This station is part of the ‘trial close-out phase’ group of stations. The Dissemination of Results station follows the Clinical Trial Summary Report station and precedes the Archiving station. ![]()
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