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NIHR policy on clinical trial registration and disclosure of results

 

Contents

Introduction and background

This policy was developed in response to NIHR signing the WHO Joint Statement on public disclosure of results from clinical trials. It sits within, and is consistent with, the Health Research Authority’s UK Policy Framework for Health and Social Care Research, and guidance on the publication and dissemination of research findings.

Prospective study Registration and timely disclosure of results are critical to ensure full transparency of Clinical Trials funded by NIHR. These principles are also important for ethical, moral, accountability, research integrity and waste reduction perspectives.

This policy aims to improve practice in prospective registration and timely disclosure of results, with the objective of raising the probability of impact of NIHR-funded research through greater transparency. This supports NIHR’s mission to improve the health and wealth of the nation through research.

This policy is established on the following principles:

  • Minimising the burden on researchers, participants and NIHR.
  • Ensuring the re-use of existing systems and data, where possible.
  • Providing a fully transparent and accessible portfolio of research.
  • Being mindful of changes to requirements over time, both historically and in the future.

Scope

This policy applies to all Clinical Trials actively recruiting on or after the Implementation Date (20 May 2019). 

This policy applies to Clinical Trials where all of the research costs (as defined by AcoRD) are funded by the NIHR. This includes Clinical Trials in receipt of research costs through any NIHR scheme (e.g. NIHR Academy, programmes, infrastructure, etc).  

Clinical Trials within scope must be registered before the first participant receives an intervention

All NIHR-funded primary research studies are required to register in an appropriate registry. The NIHR’s registry of choice is the International Standard Randomised Controlled Trial Number Register (ISRCTN). In some cases, other recognised registries may be appropriate or required for the primary registry; e.g. where there is a regulatory requirement. In such cases, NIHR will only require registration once, and will therefore waive the requirement for Registration in ISRCTN. Registration advice is provided in the documentation supplied by NIHR programmes as part of the application, contracting and start-up processes.

Registration must occur prior to the start of an intervention as part of the Clinical Trial.

Responsibility for timely trial Registration resides with the Chief (Principal) Investigator in receipt of NIHR funds. Accountability resides with the sponsoring organisation.

Registries must be updated during the study and key outcomes and trial protocols are to be made publicly available within 12 months from Primary Study Completion

Registry information should be updated regularly as appropriate and in line with instructions from the relevant NIHR secretariat/monitoring team and ISRCTN (or relevant registry) guidelines, including any changes to recruitment data and key outcomes.

The initial trial protocol should be publicly available before the first participant receives an intervention, unless otherwise agreed with the funding NIHR programme. Any approved changes to the protocol should be updated on the registry as early as possible, with a clear change protocol, and in accordance with NIHR guidelines. 

Summary Results should be quality-assured and validated by the research team. 

Responsibility for registry updating and availability of key outcomes and trial protocol resides with the Chief (Principal) Investigator in receipt of NIHR funds. Accountability resides with the sponsoring organisation. 

Trial findings should be published in a Peer-Reviewed journal or platform within 24 months from Primary Study Completion

Publication of trial findings in a Peer-Reviewed Open Access journal or platform, and in compliance with the NIHR Open Access policy, is a requirement of this policy. NIHR acknowledges publication in a Peer-Reviewed journal or platform is not within the complete control of the research team and so set an indicative timeframe of 24 months from Primary Study Completion. Where any fee is payable to ensure Open Access, this will be covered in accordance with the NIHR Open Access Policy. The fundamental principle remains that trial findings must be published as early as possible.

Trial findings should be disseminated to participants and others involved in the research once results have been published and if they have said they want to be kept informed, according to UK Policy Framework for Health and Social Care Research and NIHR advice on dissemination.

Responsibility for timely publication of findings within a Peer-Reviewed Open Access journal resides with the Chief (Principal) Investigator in receipt of NIHR funds. Accountability resides with the sponsoring organisation. 

Past Registration and publication practice will be taken into account when reviewing applications for funding of new Clinical Trials

When submitting an application to NIHR programmes for funding for a new clinical trial, the applicant must disclose past publication and trial Registration history for any relevant publications and research grants held, referenced in the application. 

This policy is considered good practice and retrospective compliance is encouraged, although it will not be viewed as mandatory. NIHR will consider previous Registration and publication amongst a range of other criteria when making funding decisions

However, NIHR recognises that there may be exceptional circumstances where good practice has not been possible and applicants may comment on why Registration and/or publication was not possible. NIHR will follow up where repeated noncompliance is identified.

Responsibility for retrospective Registration and publication of findings resides with the Chief (Principal) Investigator in receipt of NIHR funds. Sponsoring institutions have overall responsibility and are expected to have an approach to ensure good practice in the Registration and disclosure of findings of all Clinical Trials.

Monitoring and reporting on compliance

The expectation is that institutions that sponsor Clinical Trials, within the scope outlined in section 2, have an approach to ensure compliance with this NIHR policy. Compliance will be monitored for all trials in scope through an NIHR audit process.

All relevant Clinical Trial registry information must be reported via agreed progress reporting schedules

NIHR will publish an annual audit report on compliance with this policy in the public domain, highlighting compliance details of Registration and publication of results reported

The audit report will be drawn together through existing data sources where available.

Sponsoring institutions are expected to have an approach in place to ensure compliance with this policy

Sharing research data

Research data are an important output from Clinical Trials and NIHR expects appropriate re-use of data. This is important because re-use of data increases the impact resulting from the initial financial, research infrastructure, and research participants’ investments needed to collect data. Appropriately anonymised datasets from NIHR research should be made available for further analysis wherever possible.

All NIHR Clinical Trials, within the scope outlined in section 2, are required to comply with NIHR’s position statement on the sharing of research data

Policy review

NIHR is committed to continuous improvement in the field of research openness and transparency. As such, this policy will be kept under review at least annually, with the results of the next formal review due on or before 20th May 2020

Definitions

Clinical Trials - A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.

Peer-Reviewed - An appropriate process of independent expert review has demonstrated that the research proposal is worthwhile, of high scientific quality and represents good value for money

Open Access – Open access literature is digital, online, free of charge, and free of most copyright and licensing restrictions. NIHR has an Open Access policy that applies to its funded research

Primary Outcome - Primary Outcome is the data or results, as specified in the trial protocol, from which the main aim of the clinical trial can be assessed.

Registration means completing the registration process and obtaining a unique trial registration number. All NIHR-funded primary research projects are required to register onto the International Standard Randomised Controlled Trial Number Register (ISRCTN). In some cases other recognised registries may be appropriate for the primary registry

Primary Study Completion - Date of the last visit of the last subject for collection of data on the Primary Outcome (WHO definition)

Summary Results - Summary results include information on the primary and any secondary outcomes measured and statistical analysis.