Data Sharing Goals for Nonprofit Funders of Clinical Trials

Coetzee, Timothy; Ball, Mad Price; Boutin, Marc; Bronson, Abby; Dexter, David T.; English, Rebecca A; Furlong, Patricia; Goodman, Andrew; Grossman, Cynthia; Hernandez, Adrian F.; Hinners, Jennifer E; Hudson, Lynn; Kennedy, Annie; Marchisotto, Mary Jane; Myers, Elizabeth; Nowell, W. Benjamin; Nosek, Brian A.; Sherer, Todd; Shore, Carolyn; Sim, Ida; Smolensky, Luba; Williams, Christopher; Wood, Julie; Terry, Sharon F.; Matrisian, Lynn M.

doi:10.2196/23011

Cited by 2 publications

(1 citation statement)

References 14 publications

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“…Funders can play a pivotal role in promoting data-sharing practices, and encourage IPD sharing for their grant recipients (Coetzee et al, 2021). During the pandemic, most of the funding agencies were concerned about sharing trial data, and these funders were guided by their own data-sharing policies (Gaba et al, 2020).…”

Section: Discussionmentioning

confidence: 99%

Individual participant data sharing intentions and practices during the coronavirus disease-2019 pandemic: A rapid review

et al. 2023

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The coronavirus disease-2019 (COVID-19) pandemic has led to the irrational use of drugs in the absence of clinical management guidelines. Access to individual participant data (IPD) from clinical trials aids the evidence synthesis approaches. We undertook a rapid review to infer IPD sharing intentions based on data availability statements by the principal investigators (PIs) of drug and vaccine trials in the context of COVID-19. Searches were conducted on PubMed (NCBI). We considered randomized controlled trial (RCT) publications from January 1, 2020, to October 31, 2021. IPD sharing intentions were inferred based on the data availability statements in the full-text manuscript publications. We included 180 articles. Of these, 81.7% (147/180) of the publications have arrived from the findings of the RCTs alone, 12.8% (23/180) of the publications were protocol publications alone, and 5.6% (10/180) of the RCTs had both published protocol and publication from the trial findings. We have reported IPD sharing intentions separately in RCT protocol publications (n = 23 + 10) and publications from RCT findings (n = 147 + 10). Among RCT protocol publications, one-third (11/33) of the PIs intended to share IPD. In fact, over half of the PIs (52.2%, 82/157) in their published RCT findings intended to share IPD. However, information to share about IPD was missing for 57.6% (19/33) of RCT protocols and 38.2% (60/157) of published RCT findings. Stakeholders must work together to ensure that overarching factors, such as legislation that governs clinical trial practices, are streamlined to bolster IPD sharing mechanisms.

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Section: Discussionmentioning

confidence: 99%

Individual participant data sharing intentions and practices during the coronavirus disease-2019 pandemic: A rapid review

et al. 2023

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Individual Participant Data Sharing during the COVID-19 Pandemic: A Review of Individual Participant Data Sharing Intentions and Practices from Clinical Trials (Preprint)

Kamath¹,

Gudi²,

Staunton³

et al. 2022

Preprint

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BACKGROUND Individual Patient Data (IPD) meta-analyses from clinical trials bring together information from completed studies, and help in identifying effective interventions, and plan new clinical trials. During a public health emergency such as the COVID-19 pandemic, identifying effective interventions in a timely manner becomes crucial for informed clinical management. In such contexts, providing access to IPD from clinical trial(s) is a cornerstone for meta-analyses. OBJECTIVE We undertook this review is to map the extent to which clinical trial investigators share IPD during the COVID-19 pandemic. METHODS All published COVID-19 therapeutic drug, and vaccine trials from January 1, 2020 to October 31, 2021 were identified. A literature search was conducted in PubMed. Only randomized controlled trial (RCT) publications were included; the publications included were retrospectively traced to clinical trial registries in order to get access to information on trial details. Data sharing statements in the published protocol(s), and published trial finding(s) were separately analysed to describe IPD sharing intentions(s), intended time frame and reason(s), if any, for not sharing IPD. RESULTS After screening 796 publications, 180 were included. Out of 180 publications, 33 were protocol publications and 157 were findings from the RCTs. Amongst RCT protocol publications, one third (11/33) of the principal investigators (PIs) committed to share IPD, of which only 27.27% (3/11) described specific time frame. Around 9.09% (3/33) trials did not intend to share IPD; whereas 57.58% (19/33) did not disclose intention to share IPD in the published RCT protocol. On the other hand, publication of the RCT findings showed that more than half (52.23%, 82/157) of the PIs intended to share IPD. Amongst those who were willing to share IPD and had time frame to share IPD, 56.1% (46/82) described varying time frame such as at “6 months” (2.27%, 1/46) of trial completion. Similarly, 6.52% (3/46) of the PIs intended to share IPD “within or at one month” following trial publication. CONCLUSIONS Despite challenges in clinical trial data sharing, it is essential to recognise the need to make IPD available. As evident in our review, even during a pandemic the intentions to share IPD and the practice of IPD sharing has been suboptimal. Investigators’ commitment to share IPD varies greatly and there a need for systematic evaluation of the factors that prevent IPD sharing. We need collaborative efforts to promote IPD sharing in a legal and ethical manner involving various stakeholders. The COVID 19 clinical research coalition through its data sharing working group is engaging the various stakeholders, accelerating these efforts towards building consensus and mainstreaming best practices is critical in preparedness towards future public health emergencies. As governments are negotiating a proposal for an international instrument on pandemic prevention, preparedness and response, contextually appropriate IPD sharing requirements and regulations would be critical. CLINICALTRIAL Not applicable

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Data Sharing Goals for Nonprofit Funders of Clinical Trials

Cited by 2 publications

References 14 publications

Individual participant data sharing intentions and practices during the coronavirus disease-2019 pandemic: A rapid review

Individual participant data sharing intentions and practices during the coronavirus disease-2019 pandemic: A rapid review

Individual Participant Data Sharing during the COVID-19 Pandemic: A Review of Individual Participant Data Sharing Intentions and Practices from Clinical Trials (Preprint)

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