Center for Global Research Data

Reasons for Denial of Data Requests

A full list of Vivli members’ data sharing policies can be found on their member’s page.

 

Reason Data Request Denied: Out of Scope of Data Contributor’s Data Sharing Policy

Data contributorStudies Research ProposalRequest ID
Pfizer 3Efficacy of Crohn’s Disease Treatment Stratified by Disease Phenotype3190, 4949
Pfizer3Predicting Antidepressant Response in Children and Adolescents with Depression3360
Takeda2Interventions for Fatigue in Inflammatory Bowel Disease 3246
Pfizer1Risk of small for gestational age (SGA) after malaria in pregnancy using the Intergrowth 21st birth weight chart compared to a local weight chart as reference: A meta-analysis of individual participant level data5949
Pfizer3A Systematic Review to Describe the Demographic Diversity of Dermatologic Clinical Trial Participants for Common Dermatologic Diseases5086
Eli Lilly1Interferon (IFN) signatures as predictive markers of sensitivity to CDK4/6i in breast cancer6026
Pfizer1Predictors of therapeutic and adverse effects of medicines used in the treatment of gastrointestinal cancers5290
Boehringer Ingelheim1Genetic Correlation between stroke recurrence in patients treated with dabigatran and dabigatran plasma levels6628
Pfizer1Analgesic medicines for adults with low back pain: a systematic review and network meta-analysis6689
AbbVie1Identification of gene co-expression networks regulated by Interleukin-12 in RNA-sequencing data comparing skin biopsies form Ustekinumab and Risankizumab treated psoriasis patients7134
Pfizer1A Bayesian Exact Platform Design for Multi-arm trials with Concurrent or Historical Controls COVID7278
Pfizer1The Impact of Race on Short Term Treatment Response to Intravitreal anti-Vascular Endothelial Growth Factor in Diabetic Macular Edema: A Pooled Analysis6594
Takeda1A matching-adjusted indirect treatment comparison of personalised prophylaxis therapy (Nuwiq vs. Adynovate) in patients with hemophilia A7499
Boehringer Ingelheim1What are the re-identification risk scores of publicly available anonymised clinical trial datasets?7400

Reason Data Request Denied: The Data Request required data that was not collected in the studies

Data contributorStudies Research ProposalRequest ID
Boehringer Ingelheim7Patterns and predictors of toxicity with afatinib for treatment of patients with advanced EGFR mutant NSCLC4325
Biogen1Inferential reproducibility of therapeutic research: a registered report for a cross-sectional study of RCTs available on major data-sharing platforms 6055
AstraZeneca6A systematic review of the steroid sparing effect of biologicals in severe asthma6524
Biogen1The effects of systemic anti-infective concomitant medications on progression of neurological diseases7143
Takeda1The effects of systemic anti-infective concomitant medications on progression of neurological diseases7143
Boehringer Ingelheim1In patients with multi-territory acute ischaemic stroke, do direct oral anticoagulants (DOACs) reduce the risk of future stroke: RE-SPECT ESUS substudy7478
Pfizer3Responsiveness of the UC-100 Score in Patients with Moderately to Severely Active Ulcerative Colitis7549
Boehringer Ingelheim1Exploration of ailments related to back pain in the medical history data from clinical studies of healthy subjects using formal hypothesis testing and data mining7598

Reason Data Request Denied: The Data Request's project aim is commercial or litigious and The Data Request is out of scope

Data ContributorStudiesResearch ProposalRequest ID
Pfizer6Data grant application of completed neuropathic pain clinical trials using pregabalin (Lyrica®) to validate the Quantitative Data Surveillance System (QDSS)4336
Pfizer16Role of clinical, historical and demographic factors in the response to antidepressants versus placebo7541

Reason Data Request Denied: Data collected subject to legal, contractual or consent provisions that prevent further sharing of clinical data

Data contributorStudies Research ProposalRequest ID
Daiichi-Sankyo1Exploring Tripartite Estimands approach – Reanalysis of actual clinical trials to estimate the treatment effect for Clinical Trials5328
GlaxoSmithKline4Developing a Generalizable Blockchain Architecture to Enhance Clinical Trial Recruitment and Achieve Persistent Monitoring6501
Bristol-Myers Squibb2Including real-world data from expanded access programs into regulatory approval decisions and health-economic analyses: benefits and challenges5351

Reason Data Request Denied: The data contributor or sponsor doesn't have the legal authority to provide the data

Data ContributorStudiesResearch ProposalRequest ID
Boehringer Ingelheim1Tolerability of duloxetine in the elderly and in adults: a systematic review and individual patient data meta-analysis of randomized controlled trials versus placebo.4112
Pfizer2Meta-analysis of efficacy of cholinesterase inhibitors on individual neuropsychiatric symptoms in Alzheimer's disease, Parkinson's disease and dementia with Lewy bodies 5924
Pfizer1Baseline ischemic stroke risk and heterogeneity of relative and absolute benefit of statin therapy: a secondary analysis of the SPARCL trial7869
Pfizer1Alternative methods to summarize Low Density Lipoprotein Cholesterol over time in the SPARCL trial8237

Reason Data Request Denied: The Data Request competes with the data contributor/sponsor's publication plan

Data ContributorStudiesResearch ProposalRequest ID
Boehringer Ingelheim1The Effectiveness of a Software in Pulmonary Fibrosis Staging and Severity Evaluation in Idiopathic Pulmonary Fibrosis (IPF) Patients6631
Daiichi Sankyo1Big data and meta-analytic approaches for better phenotyping in atrial fibrillation and heart failure6541
Boehringer Ingelheim1Predictors of recurrent stroke in patients after embolic stroke of undetermined source (ESUS) treated with dabigatran7429
Biogen13Validation of surrogate endpoints and development of models for predicting outcomes and treatment response in relapsing-remitting multiple sclerosis patients5573
GlaxoSmithKline9Role of clinical, historical and demographic factors in the response to antidepressants versus placebo7541
Boehringer Ingelheim1Exploration of clinical outcomes in idiopathic pulmonary fibrosis and treatment response to Nintedanib by monocyte count at enrolment7859

Reason Data Request Denied: The Data Request's project aim is commercial or litigious

Data ContributorStudiesResearch ProposalRequest ID
Pfizer4Enhancing inference from real-world data using externally-derived missing data models: a pilot study of Ulcerative Colitis4041

Reason Data Request Denied: The data requested cannot be shared due to ongoing regulatory activities

Data ContributorStudiesResearch ProposalRequest ID
AstraZeneca1Validation of a Machine Learning-based Model to Predict the Risk of Heart Failure among Patients with Diabetes Mellitus: the WATCH-DM Risk Score6522
AstraZeneca1Development and validation of a prediction model for the indication of inhaled corticosteroid (ICS) in patients with chronic obstructive pulmonary disease (COPD)6712
Pfizer1Determining the impact of Tafamidis on weight loss and cachexia development in Transthyretin amyloidosis (ATTR) patients based on the ATTR-ACT trial (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTR-ACT)7286
Biogen1Investigating brain volume analysis of EMERGE and ENGAGE trials7838

Reason Data Request Denied: The Data Request did not meet the data contributor/sponsor policies for informed consent

Data ContributorStudiesResearch ProposalRequest ID
Bristol Myers Squibb2A survival extrapolation study of ipilimumab + dacarbazine (IPIflDTIC) versus placebo + dacarbazine (PBOflDTIC) in melanoma patients in NCT00324155 trial: using flexible parametric relative survival models6859
AstraZeneca1Treatment with multi-drug regimens combining Mitogen-activated protein Kinase targeted therapy and immunotherapy in melanoma6709
Bristol Myers Squibb1Validation of a new model of anticoagulant effect in patients with atrial fibrillation7397

Reason Data Request Denied: The Data Request's research proposal lacks clear scientific merit

Data ContributorStudiesResearch ProposalRequest ID
Pfizer5Data-sharing and re-analysis for main studies assessed by the European Medicines Agency - a cross-sectional study on European Public Assessment Reports5853
Regeneron1Data-sharing and re-analysis for main studies assessed by the European Medicines Agency - a cross-sectional study on European Public Assessment Reports5853
Regeneron3Recruitment and treatment outcomes of racial subgroups in Phase III clinical trial data evaluating diabetic macular edema and retinal vein occlusion.6688
Medical Research council1Independent Integrity Checking of Clinical Trials7314
Pfizer2The Impact of Second Generation Anti-Androgens on Sexual Function in Men with Advanced Prostate Cancer7316
Pfizer6Predictors of therapeutic and adverse effects of medicines used in the treatment of prostate cancer5967
Regeneron1The Impact of Race on Short Term Treatment Response to Intravitreal anti-Vascular Endothelial Growth Factor in Diabetic Macular Edema: A Pooled Analysis6594
Regeneron4Summarising the therapeutic and adverse effects of anticancer medicines according to race and sex: pooled analysis of clinical trials of contemporary treatments for solid tumours
7667
AstraZeneca5Efficacy comparison of biologics (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) in treatment of severe eosinophilic asthma — a network meta-analysis7274

Reason Data Request Denied: The data requested is not appropriate for the research proposal in the Data Request

Data ContributorStudiesResearch ProposalRequest ID
Boehringer Ingelheim3Longitudinal peripheral blood markers as dynamic predictors to identify efficacy and safety of non–small-cell lung cancer (NSCLC) patients treated with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs)

6629
Pfizer1Machine learning for personalized prediction of enzalutamide treatment outcomes in nonmetastatic castration-resistant prostate cancer7386
Pfizer2The impact of drug-drug interactions between palbociclib and proton pump inhibitors on clinical outcome of patients with hormone receptor positive, HER2-negative, advanced breast cancer7596
Boehringer Ingelheim2Evaluating Clinical Trial Data Conventions for the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM)6869

Reason Data Request Denied: There is a reasonable likelihood that a patient could be re-identified

Data ContributorStudiesResearch ProposalRequest ID
AstraZeneca2Unraveling response to immunotherapy in advanced non-small cell lung cancer using circulating tumor deoxyribonucleic acid7293
GlaxoSmithKline1Examining Variability in Data Elements and Populations in Multiple Sclerosis Clinical Trials Data - Development of Analytic and Visualization Approaches5544

Reason Data Request Denied: The data requested is unavailable

Data ContributorStudiesResearch ProposalRequest ID
Biogen12Examining Variability in Data Elements and Populations in Multiple Sclerosis Clinical Trials Data - Development of Analytic and Visualization Approaches5544

Reason for Denial of Studies in a Data Request

Data contributorStudies Reason of Non-ApprovalResearch ProposalRequest ID
Pfizer2The Data Requested is out of scope of data sharing policyIdentification of Research Common Data Elements in HIV/AIDS using data science methods 3244
Pfizer1The Data requested is unavailablePredicting Treatment Response to Tumor Necrosis Factor Inhibitors in Patients with Ankylosing Spondylitis 3369
Boehringer Ingelheim1Document not available in EnglishRisk and Benefit Stratification of Treatment Effects in Patients with Atrial Fibrillation 3876
Eli Lilly5The data contributor or sponsor doesn't have the legal authority to provide the dataTolerability of duloxetine in the elderly and in adults: a systematic review and individual patient data meta-analysis of randomized controlled trials versus placebo.4112
Boehringer Ingelheim2The data requested is not appropriate for the research proposal in the Data RequestPredictors of therapeutic and adverse effects of medicines used in the treatment of breast cancer5289
UCB1Data collected subject to legal, contractual or consent provisions that prevent further sharing of clinical dataAntiepileptic drug monotherapy for epilepsy: an updated Cochrane review and individual participant data network meta-analysis5291
AbbVie1There is a reasonable likelihood that a patient could be re-identifiedSharing of Progressive Supranuclear Palsy (PSP) data with the Rare Disease Cures Accelerator - Data and Analytics Platform for Analysis of Outcome Measures and Other Purposes5989
Roche1The Data Requested is out of scope of data sharing policyPredictors of therapeutic and adverse effects of medicines used in the treatment of breast cancer5289
Pfizer1The data requested is unavailableComparative efficacy and tolerability of new-generation antidepressants for major depressive disorder in children and adolescents: protocol of an individual patient data meta-analysis4324
Pfizer3The data requested is unavailableInferential reproducibility of therapeutic research: a registered report for a cross-sectional study of RCTs available on major data-sharing platforms6055
Boehringer Ingelheim1The data contributor or sponsor doesn't have the legal authority to provide the dataAssessing heterogeneity in relative treatment efficacy by age, sex and comorbidity.5483
GlaxoSmithKline1The data requested is unavailableTositumomab: statistical modeling of expanded access programs and conventional trials6477
AbbVie1There is a reasonable likelihood that a patient could be re-identified (due to the very small number of patients)Exploring the heterogeneity of cognitive profile in patients with Progressive Supranuclear Palsy (PSP) enrolled in the ABBV-8E12 trial and the relationship to brain volumes7147
AstraZeneca1The Data Request competes with the data contributor/sponsor's publication/dissemination planEvaluation of available statistical methods performance under non-proportional hazards6483
Roche2The data requested is unavailablePredictors of therapeutic and adverse effects of medicines used in the treatment of breast cancer5289, 6499
AstraZeneca1Out of Scope of Data Contributor’s Data Sharing PolicyPredictors of therapeutic and adverse effects of medicines used in the treatment of breast cancer5289, 6499
UCB1Data collected subject to legal, contractual or consent provisions that prevent further sharing of clinical dataReal time monitoring of individual response to antiseizure medication treatment during clinical trials7161
Roche2Studies where data sharing is prohibited by the consent, legal, regulatory, or contractual constraints on data sharing.Evaluating the association between proteinuria and thrombosis and its predictors in patients treated with Bevacizumab6066
Abbvie1The data requested is not appropriate for the research proposal in the Data RequestDisease‐modifying anti‐rheumatic drugs for rheumatoid arthritis: A network meta-analysis incorporating individual patient data5987
AstraZeneca1Studies where data sharing is prohibited by the consent, legal, regulatory, or contractual constraints on data sharingExploration of regional heterogeneity in trials assessing the efficacy of recent non-insulin glucose lowering drugs on cardiovascular outcomes
6593
AstraZeneca4Study cannot be shared this time due to ongoing regulatory activitiesSummarising the therapeutic and adverse effects of anticancer medicines according to race and sex: pooled analysis of clinical trials of contemporary treatments for solid tumours7667
Pfizer3The data requested is not appropriate for the research proposal in the Data RequestSummarising the therapeutic and adverse effects of anticancer medicines according to race and sex: pooled analysis of clinical trials of contemporary treatments for solid tumours7667
AstraZeneca1The data requested cannot be shared due to ongoing regulatory activitiesEvaluating Clinical Trial Data Conventions for the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM)6869
GlaxoSmithKline1The Data Request required data that was not collected in the studies requestedEvaluating Clinical Trial Data Conventions for the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM)6869
UCB1The Data Request did not meet the data contributor/sponsor policies for informed consentWhat are the re-identification risk scores of publicly available anonymised clinical trial datasets?7400