A Historic Moment for Open Science: The Yale University Open Data Access Project and Medtronic

Krumholz, Harlan M.; Ross, Joseph S.; Gross, Cary P.; Emanuel, Ezekiel J.; Hodshon, Beth; Ritchie, Jessica D.; Low, Jeffrey B.; Lehman, Richard

doi:10.7326/0003-4819-158-12-201306180-00009

Cited by 62 publications

(37 citation statements)

References 9 publications

(9 reference statements)

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“…Dissemination is principally achieved through publication in peer reviewed biomedical journals as well as through public reporting of results on clinical trial registries. [1][2][3][4] However, a large body of research found that between 25% and 50% of clinical trials remain unpublished, sometimes years after study completion. [5][6][7][8][9] Similarly, studies have shown that the results of many clinical trials are not reported promptly on ClinicalTrials.gov.…”

Section: Introductionmentioning

confidence: 99%

Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers

Chen

Desai

Ross

et al. 2016

BMJ

188

166

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ObjeCtiveTo determine rates of publication and reporting of results within two years for all completed clinical trials registered in ClinicalTrials.gov across leading academic medical centers in the United States.Design Cross sectional analysis.setting Academic medical centers in the United States. PartiCiPantsAcademic medical centers with 40 or more completed interventional trials registered on ClinicalTrials.gov. MethODsUsing the Aggregate Analysis of ClinicalTrials.gov database and manual review, we identified all interventional clinical trials registered on ClinicalTrials. gov with a primary completion date between October 2007 and September 2010 and with a lead investigator affiliated with an academic medical center. Main OutCOMe MeasuresThe proportion of trials that disseminated results, defined as publication or reporting of results on ClinicalTrials.gov, overall and within 24 months of study completion. resultsWe identified 4347 interventional clinical trials across 51 academic medical centers. Among the trials, 1005 (23%) enrolled more than 100 patients, 1216 (28%) were double blind, and 2169 (50%) were phase II through IV. Overall, academic medical centers disseminated results for 2892 (66%) trials, with 1560 (35.9%) achieving this within 24 months of study completion. The proportion of clinical trials with results disseminated within 24 months of study completion ranged from 16.2% (6/37) to 55.3% (57/103) across academic medical centers. The proportion of clinical trials published within 24 months of study completion ranged from 10.8% (4/37) to 40.3% (31/77) across academic medical centers, whereas results reporting on ClinicalTrials.gov ranged from 1.6% (2/122) to 40.7% (72/177). COnClusiOnsDespite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers.

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Section: Introductionmentioning

confidence: 99%

Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers

Chen

Desai

Ross

et al. 2016

BMJ

188

166

View full text Add to dashboard Cite

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“…In 2011, Medtronic released safety data, post-marketing data and full patient-level data from 17 studies of its product INFUSE® Bone Graft (recombinant human bone morphogenetic protein-2) [8,63]. INFUSE has been approved by the FDA since 2002 as an orthobiologic agent used to promote bone growth after certain surgeries [15,24,64]. …”

Section: Contextmentioning

confidence: 99%

“…Arguments which have been raised by investigators and industry against mandatory data sharing include such potential issues as the additional cost of preparing data for release, use of data by competitors to accelerate their development programmes, legal trouble such as groundless litigation or the inability to obtain patent rights due to prior public disclosure, health scares caused by misinterpretation of data, and the possibility of endangering the confidentiality of patients, particularly those with rare diseases who are easier to re-identify due to their limited numbers [8,9,13,15,20,21,22,23,24]. …”

Section: Introductionmentioning

confidence: 99%

“…Data sharing minimises redundant data collection, reducing costs and safety risks; allows results to be verified and pooled for meta-analysis; reveals new trends and enables further research; strengthens collaboration between data users; allows physicians and patients to make informed and evidence-based decisions; honours the contribution of trial participants; and builds trust in clinical research so that more people will be willing to join trials in the future [8,9,10,11,12,13,14,15,16]. …”

Section: Introductionmentioning

confidence: 99%

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Clinical Trial Transparency and Orphan Drug Development: Recent Trends in Data Sharing by the Pharmaceutical Industry

Joly²,

Knoppers³

2013

Public Health Genomics

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Background: Data sharing from clinical trials can be key to the development and approval of medicines for rare diseases. Many events during the first half of 2013 have contributed to the movement for increased transparency. These include the development of the European Medicines Agency's new data publication policy, the creation of the AllTrials petition and GlaxoSmithKline's choice to sign it, the launch of GlaxoSmithKline's system for access to patient-level clinical trial data and Roche's commitment to create a similar system, the release of results from the Yale University Open Data Access project's first medicine analysis for Medtronic, and the creation of the Reg4All website. Aims/Objectives: This paper summarises major developments in clinical trial transparency between January and June 2013 and analyses the composition of datasets released by GlaxoSmithKline. Methods: GlaxoSmithKline's database of available trials was tabulated and graphs of relevant trial characteristics were produced. Results/Conclusions: Due to current transparency initiatives, it is likely that much more data will be made available over the next few years through systems similar to GlaxoSmithKline's. Although some aspects of GlaxoSmithKline's model could limit its usefulness, the data currently listed is diverse and could be promising for researchers interested in rare disease treatment.

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“…The Yale University Open Data Access Project commissioned the reviews, believing that confidence in the findings would be greatest if both reached the same conclusions. Both include patientlevel meta-analyses of data from randomized, controlled trials (RCTs) obtained from Medtronic (Minneapolis, Minnesota), the manufacturer of rhBMP-2 (3)(4)(5). Annals' review involved 2 internal teams of physician and statistical editors and distinct sets of external reviewers.…”

mentioning

confidence: 99%

Closing in on the Truth About Recombinant Human Bone Morphogenetic Protein-2: Evidence Synthesis, Data Sharing, Peer Review, and Reproducible Research

Lainé¹,

Güallar²,

Mulrow³

et al. 2013

Ann Intern Med

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A Historic Moment for Open Science: The Yale University Open Data Access Project and Medtronic

Cited by 62 publications

References 9 publications

Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers

Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers

Clinical Trial Transparency and Orphan Drug Development: Recent Trends in Data Sharing by the Pharmaceutical Industry

Closing in on the Truth About Recombinant Human Bone Morphogenetic Protein-2: Evidence Synthesis, Data Sharing, Peer Review, and Reproducible Research

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