Data Sharing from Clinical Trials — A Research Funder’s Perspective

Kiley, Robert; Peatfield, Tony; Hansen, Jennifer; Reddington, Fiona

doi:10.1056/nejmsb1708278

Cited by 76 publications

(59 citation statements)

References 4 publications

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“…funders increasingly see open and reproducible science as part of necessary requirements and heavily encourage their adoption (Flier, 2017, Kiley, Peatfield, Hansen, & Reddington, 2017. Recently funders have also offered funding specifically for replications (e.g.…”

Section: Benefit 3: Investment In the Futurementioning

confidence: 99%

Open Science challenges, benefits and tips in early career and beyond

Allen¹,

Mehler²

2018

Preprint

144

197

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The movement towards open science is an unavoidable consequence of seemingly pervasive failures to replicate previous research. This transition comes with great benefits but also significant challenges that are likely to afflict those who carry out the research, usually Early Career Researchers (ECRs). Here, we describe key benefits including reputational gains, increased chances of publication and a broader increase in the reliability of research. These are balanced by challenges that we have encountered, and which involve increased costs in terms of flexibility, time and issues with the current incentive structure, all of which seem to affect ECRs acutely. Although there are major obstacles to the early adoption of open science, overall open science practices should benefit both the ECR and improve the quality and plausibility of research. We review three benefits, three challenges and provide suggestions from the perspective of ECRs for moving towards open science practices.

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Section: Benefit 3: Investment In the Futurementioning

confidence: 99%

Open Science challenges, benefits and tips in early career and beyond

Allen¹,

Mehler²

2018

Preprint

144

197

View full text Add to dashboard Cite

show abstract

“…The legal, ethical, and social implications of clinical data and sample sharing are largely being debated by journal editors, pharmaceutical companies, funding agencies, governmental organization, regulators, clinical investigators, etc. (15)(16)(17)(18)(19)(20). Many uphold a moral obligation vis-à-vis study participants (i.e., "research participants want their data to be used for further research") as the number one motivation for increased sharing efforts.…”

Section: Introductionmentioning

confidence: 99%

Sharing of Clinical Trial Data and Samples: The Cancer Patient Perspective

et al. 2020

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Introduction: Today, many initiatives and papers are devoted to clinical trial data (and to a lesser extent sample) sharing. Journal editors, pharmaceutical companies, funding agencies, governmental organizations, regulators, and clinical investigators have been debating the legal, ethical, and social implications of clinical data and sample sharing for several years. However, only little research has been conducted to unveil the patient perspective. Aim: To substantiate the current debate, we aimed to explore the attitudes of patients toward the re-use of clinical trial samples and data and to determine how they would prefer to be involved in this process. Materials and Methods: Sixteen in-depth interviews were conducted with cancer patients currently participating in a clinical trial. Results: This study indicates a general willingness of cancer patients participating in a clinical trial to allow re-use of their clinical trial data and/or samples by the original research team, and a generally open approach to share data and/or samples with other research teams, but some would like to be informed in this case. Despite divergent opinions about how patients prefer to be engaged, ranging from passive donors up to those explicitly wanting more control, participants expressed positive opinions toward technical solutions that allow indicating their preferences. Conclusion: Patients were open to sharing and re-use of data and samples to advance medical research but opinions varied on the level of patient involvement and the need for re-consent. A stratified approach for consent that allows individualization of data and sample sharing preferences may be useful, yet the implementation of such an approach warrants further research.

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“…Funders are increasingly encouraging researchers to make their data available after study completion to maximise the opportunity for health improvement from public investment in research;37 however, we found little evidence of trial datasets being prepared or made available for reuse by researchers. In recent years, significant efforts have been made to develop guidance38–41 and services to enable researchers to share data, including data repositories and online catalogues, independent access review committees, secure platforms for data access and analysis, and data anonymisation tools to reduce disclosure risk 42–45.…”

Section: Discussionmentioning

confidence: 66%

Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK

Knowles

Mueller

et al. 2020

BMJ Open

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ObjectivesTo evaluate compliance by researchers with funder requirements on clinical trial transparency, including identifying key areas for improvement; to assess the completeness, accuracy and suitability for annual compliance monitoring of the data routinely collected by a research funding body.DesignDescriptive analysis of clinical trials funded between February 2011 and January 2017 against funder policy requirements.SettingPublic medical research funding body in the UK.Data sourcesRelevant clinical trials were identified from grant application details, post-award grant monitoring systems and the International Standard Randomised Controlled Trial Number (ISRCTN) registry.Main outcome measureThe proportion of all Medical Research Council (MRC)-funded clinical trials that were (a) registered in a clinical trial registry and (b) publicly reported summary results within 2 years of completion.ResultsThere were 175 grants awarded that included a clinical trial and all trials were registered in a public trials registry. Of 62 trials completed for over 24 months, 42 (68%) had publicly reported the main findings by 24 months after trial completion; 18 of these achieved this within 12 months of completion. 11 (18%) trials took >24 months to report and 9 (15%) completed trials had not yet reported findings. Five datasets were shared with other researchers.ConclusionsCompliance with the funder policy requirements on trial registration was excellent. Reporting of the main findings was achieved for most trials within 24 months of completion; however, the number of unreported trials remains a concern and should be a focus for future funder policy initiatives. Identifying trials from grant management and grant monitoring systems was challenging therefore funders should ensure investigators reliably provide trial registries with information and regularly update entries with details of trial publications and protocols.

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Data Sharing from Clinical Trials — A Research Funder’s Perspective

Cited by 76 publications

References 4 publications

Open Science challenges, benefits and tips in early career and beyond

Open Science challenges, benefits and tips in early career and beyond

Sharing of Clinical Trial Data and Samples: The Cancer Patient Perspective

Challenges for funders in monitoring compliance with policies on clinical trials registration and reporting: analysis of funding and registry data in the UK

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