Overview and experience of the YODA Project with clinical trial data sharing after 5 years

Ross, Joseph S.; Waldstreicher, Joanne; Bamford, Steven P.; Berlin, Jesse A.; Childers, Karla; Desai, Nihar R.; Gamble, Ginger; Gross, Cary P.; Kuntz, Richard E.; Lehman, Richard; Lins, Peter; Morris, Sandra A.; Ritchie, Jessica D.; Krumholz, Harlan M.

doi:10.1038/sdata.2018.268

Cited by 60 publications

(76 citation statements)

References 36 publications

(26 reference statements)

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“…21 The YODA project is one example of data sharing that has pooled clinical trial data since 2013 and facilitated secondary use of the database. 28 While data from industrysupported clinical trials can provide a rich substrate from which to conduct secondary analyses, their utility and generalizability may be less robust with respect to older patients who are often excluded from these studies because of their age or because they have medical conditions and/or are prescribed medications for these conditions.…”

Section: How Will Decisions About How the Data Are Used Be Made?mentioning

confidence: 99%

The Global Aging & Geriatric Experiments in Bipolar Disorder Database (GAGE‐BD) project: Understanding older‐age bipolar disorder by combining multiple datasets

et al. 2019

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Objective There is a dearth of research about the aging process among individuals with bipolar disorder (BD). One potential strategy to overcome the challenge of interpreting findings from existing limited older‐age bipolar disorder (OABD) research studies is to pool or integrate data, taking advantage of potential overlap or similarities in assessment methods and harmonizing or cross‐walking measurements where different measurement tools are used to evaluate overlapping construct domains. This report describes the methods and initial start‐up activities of a first‐ever initiative to create an integrated OABD‐focused database, the Global Aging & Geriatric Experiments in Bipolar Disorder Database (GAGE‐BD) project. Methods Building on preliminary work conducted by members of the International Society for Bipolar Disorders OABD taskforce, the GAGE‐BD project will be operationalized in four stages intended to ready the dataset for hypothesis‐driven analyses, establish a consortium of investigators to guide exploration, and set the stage for prospective investigation using a common dataset that will facilitate a high degree of generalizability. Results Initial efforts in GAGE‐BD have brought together 14 international investigators representing a broad geographic distribution and data on over 1,000 OABD. Start‐up efforts include communication and guidance on meeting regulatory requirements, establishing a Steering Committee to guide an incremental analysis strategy, and learning from existing multisite data collaborations and other support resources. Discussion The GAGE‐BD project aims to advance understanding of associations between age, BD symptoms, medical burden, cognition and functioning across the life span and set the stage for future prospective research that can advance the understanding of OABD.

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Section: How Will Decisions About How the Data Are Used Be Made?mentioning

confidence: 99%

The Global Aging & Geriatric Experiments in Bipolar Disorder Database (GAGE‐BD) project: Understanding older‐age bipolar disorder by combining multiple datasets

et al. 2019

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“…https://doi.org/10.1101/19000463 doi: medRxiv preprint Similarly, Supporting Open Access to Research (SOAR), a partnership between Bristol-Myer Squibb (BMS) and Duke Clinical Research Institute, provides access to BMS trial data. 48 There are also university-based platforms, included the Yale Open Data Access (YODA) project, which has partnered with Johnson & Johnson, Medtronic, Inc., and SI-BONE, Inc. 24,49,50 Not only do these platforms ensure that all shared data are deidentified, they also require requestors to pre-specify their research questions and methods. Furthermore, they employ a "trusted intermediary" approach, with independent review committees screening detailed proposals and making data-sharing decisions.…”

Section: Data Sharing Implicationsmentioning

confidence: 99%

Updating Insights into Rosiglitazone and Cardiovascular Risk through Shared Data: Individual Patient- and Summary-Level Meta-Analyses

Wallach

Wang

Zhang

et al. 2019

Preprint

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Objective: To conduct a systematic review and meta-analysis of the effects of rosiglitazone therapy on cardiovascular risk and mortality using multiple data sources and varying analytical approaches. Design: Systematic review and meta-analysis of randomized controlled trials. Data sources: GlaxoSmithKline's (GSK) Clinical Study Data Request (CSDR) and Study Register platforms, MEDLINE, PubMed, Embase, Web of Science, Cochrane Central Registry of Controlled Trials, Scopus, and ClinicalTrials.gov from inception to January 2019. Study selection criteria: Randomized, controlled, phase II-IV clinical trials comparing rosiglitazone with any control for at least 24 weeks in adults. Data extraction and synthesis: For analyses of trials for which individual patient-level data (IPD) were available, we examined a composite of the following events as our primary outcome: acute myocardial infarction, heart failure, cardiovascular-related deaths, and non-cardiovascular-related deaths. As secondary analyses, these four events were examined independently. When also including trials for which IPD were not available, we examined myocardial infarction and cardiovascular-related deaths, ascertained from summary-level data. Multiple meta-analyses were conducted, accounting for trials with zero events in one or all arms with two different continuity corrections (i.e., 0.5 constant and treatment arm comparator continuity correction), to calculate odds ratios and risk ratios with 95% confidence intervals. Results: There were 33 eligible trials for which IPD were available (21156 participants) through GSK's CSDR. We also identified 103 additional trials for which IPD were not available from which we ascertained myocardial infarctions (23683 patients) and 103 trials for cardiovascular-related deaths (22772 patients). Among trials for which IPD were available, we identified a greater number of myocardial infarctions and fewer cardiovascular-related deaths reported in the IPD as compared to the summary-level data. When limited to trials for which IPD were available and accounting for trials with zero-events in only one arm using a constant continuity correction of 0.5, patients treated with rosiglitazone had a 39% increased risk of a composite event compared with controls (Mantel-Haenszel odds ratio 1.39, 95% CI 1.15 to 1.68). When examined separately, the odds ratios for myocardial infarction, heart failure, cardiovascular-related death, and non-cardiovascular-related death were 1.25 (0.99 to 1.60), 1.60 (1.20 to 2.14), 1.18 (0.64 to 2.17), and 1.13 (0.58 to 2.20), respectively. When all trials for which IPD were and were not available were combined for myocardial infarction and cardiovascular-related deaths, the odds ratios were attenuated (1.13 (0.92 to 1.38) and 1.10 (0.73 to 1.65), respectively). Effect estimates and 95% confidence intervals were broadly consistent when analyses were repeated including trials with zero events across all arms using constant continuity corrections of 0.5 or treatment arm continuity corrections. Conclusions: Results of this comprehensive meta-analysis aggregating a multitude of trials and analyzed using a variety of statistical techniques suggest that rosiglitazone is consistently associated with an increased cardiovascular risk, likely driven by heart failure events, whose interpretation is complicated by varying magnitudes of myocardial infarction risk that were attenuated through aggregation of summary-level data in addition to IPD.

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“…This term refers to the distribution of individual participant-level clinical trial data to other researchers to enable independent use for scientific purposes. 16 Over recent years, the importance of sharing data from clinical trials has substantially grown and several major organizations and institutions have developed policies and recommendations to promote the development of data sharing. 17 However, data sharing is a very complex enterprise, both legally and logistically.…”

Section: Introductionmentioning

confidence: 99%

“…In addition, a major logistical problems associated with data sharing is a lack of complete infrastructure to suport sharing data on a global scale. 18 Therefore, despite many benefits of data sharing and a wide promotion of this idea, 16,17 the access of investigators to individual participant-level datasets remains rather limited. For instance, a recent study showed that only 15% of clinical trials sponsored by pharmaceutical industry were available for data sharing 2 years after publication of primary results.…”

Section: Introductionmentioning

confidence: 99%

Legal regulations, ethical guidelines and recent policies to increase transparency of clinical trials

Borysowski

Wnukiewicz-Kozłowska

Górski

2020

Brit J Clinical Pharma

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Timely and accurate dissemination of outcomes is essential to accomplish main benefits of scientific research including clinical trials. Clinical trial results can be disseminated in two main ways: by publication in a peer‐reviewed journal and by posting on a publicly available clinical trial register. The credibility of the literature on clinical trials is significantly diminished because a high percentage of trials is not published. While current legal regulations both in the European Union (EU) and the USA impose a duty to submit summary results of clinical trials to a respective register (EU Clinical Trial Register and http://ClinicalTrials.gov, respectively), the compliance with this requirement has been generally inadequate. Trial outcomes can be also made accessible by data sharing. However, in spite of the wide promotion of this idea, the access of investigators to participant‐level datasets remains limited. The main objective of this review is to discuss current legal regulations, international standards, ethical guidelines and recent policies pertaining to dissemination of clinical trial results.

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Overview and experience of the YODA Project with clinical trial data sharing after 5 years

Cited by 60 publications

References 36 publications

The Global Aging & Geriatric Experiments in Bipolar Disorder Database (GAGE‐BD) project: Understanding older‐age bipolar disorder by combining multiple datasets

The Global Aging & Geriatric Experiments in Bipolar Disorder Database (GAGE‐BD) project: Understanding older‐age bipolar disorder by combining multiple datasets

Updating Insights into Rosiglitazone and Cardiovascular Risk through Shared Data: Individual Patient- and Summary-Level Meta-Analyses

Legal regulations, ethical guidelines and recent policies to increase transparency of clinical trials

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