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Center for Global Research Data

Publications

PUBLICATIONS FROM RESEARCH PROPOSALS

The table provides details of approved research proposals that have published or presented their results.

Data Request IDLead InvestigatorInstitutionResearch Proposal TitlePublication
4036Akira KimataUniversity of TsukubaOptimal interruption time of dabigatran per OS to Ablation (O-A time) in patients with atrial fibrillation Integrated analysis of 2 randomized controlled clinical trialsCirculation. Late-Breaking Science Abstracts and Featured Science Abstracts From the American Heart Association’s Scientific Sessions 2019 and Late-Breaking Abstracts in Resuscitation Science From the Resuscitation Science Symposium 2019, Volume: 140, Issue: 25, Pages: e965-e1011, DOI: (10.1161/CIR.0000000000000742)

10.1161/CIR.0000000000000742
3320John FrewRockefeller UniversityAnalysis of Outcome Measures in Hidradenitis SuppurativaClinical Response Rates, Placebo Response Rates and Significantly Associated Covariates Are Dependent Upon Choice of Outcome Measure in Hidradenitis Suppurativa: A Post-Hoc Analysis of PIONEER 1 and 2 Individual Patient Data
Frew, John W. et al.
Journal of the American Academy of Dermatology, Volume 0, Issue 0

10.1016/j.jaad.2019.12.044
4117John FrewRockefeller UniversityPredictors of Treatment Response, Adverse Events, Changes in Anaemia status and Assessment of Lesion Count Variability in Hidradenitis Suppurativa Malignancy and Infection Risk During Adalimumab Therapy in Hidradenitis Suppurativa. Frew, J., Jiang, C., Singh, N., Grand, D., Navrazhina, K., Vaughan, R. and Krueger, J. (2020), Clin Exp Dermatol. Accepted Author Manuscript.

10.1111/ced.14264

4319Maria Alice FranzoiJules Bordet Institut Clinical implications of body mass index and weight in metastatic breast cancer patients receiving abemaciclib. A combined individual patient level data sub-analysis of MONARCH 2 and MONARCH 3 trials153P Clinical implications of body mass index (BMI) and weight in metastatic breast cancer (BC) patients treated with abemaciclib and endocrine therapy: A pooled individual patient level data analysis of MONARCH 2 and MONARCH 3 trials. Franzoi, M.A. et al. Annals of Oncology, Volume 31, S71.

https://doi.org/10.1016/j.annonc.2020.03.253
4319Maria Alice FranzoiJules Bordet Institut Clinical implications of body mass index in metastatic breast cancer patients treated with abemaciclib and endocrine therapyMaria Alice Franzoi, MD, Daniel Eiger, MD, Lieveke Ameye, MSc, Noam Ponde, MD, Rafael Caparica, MD, Claudia De Angelis, MD, Mariana Brandão, MD, Christine Desmedt, PhD, Serena Di Cosimo, MD, Nuria Kotecki, MD, Matteo Lambertini, MD PhD, Ahmad Awada, MD PhD, Martine Piccart, MD PhD, Evandro de Azambuja, MD PhD, Clinical implications of body mass index in metastatic breast cancer patients treated with abemaciclib and endocrine therapy, JNCI: Journal of the National Cancer Institute, djaa116,

https://doi.org/10.1093/jnci/djaa116
3320John FrewRockefeller UniversityAnalysis of Outcome Measures in Hidradenitis SuppurativaFrew, J., Jiang, C., Singh, N., Grand, D., Navrazhina, K., Vaughan, R. and Krueger, J. (2020), Dermal Tunnels Influence Time to Clinical Response and Family History Influences Time to Loss of Clinical Response in Hidradenitis Suppurativa Patients Treated with Adalimumab.
Clinical and Experimental Dermatology. Accepted Author Manuscript.

doi:10.1111/ced.14448
5327Jose Antonio Pereira da SilvaUniversidade de Coimbra, PortugalLong-term predictive value of patient global assessment regarding radiographic damage and physical function in patients with Rheumatoid Arthritis individual patient data meta-analysisFerreira RJO, Welsing PMJ, Jacobs JWG, et al. Revisiting the use of remission criteria for rheumatoid arthritis by excluding patient global assessment: an individual meta-analysis of 5792 patients. Annals of the Rheumatic Diseases Published Online First: 06 October 2020.

doi: 10.1136/annrheumdis-2020-217171
3320John FrewRockefeller UniversityAnalysis of Outcome Measures in Hidradenitis SuppurativaFrew J, Jiang C, Singh N, Navrazhina K, Vaughan R, Krueger J, Quantifying the Natural Variation in Lesion Counts Over Time in Untreated Hidradenitis Suppurativa: Implications
for Outcome Measures and Trial Design, JAAD International (2020),

doi: https://doi.org/10.1016/j.jdin.2020.09.005
3369Michael WardNational Institutes of Health (NIH)Predicting Treatment Response to Tumor Necrosis Factor Inhibitors in Patients with Ankylosing SpondylitisWang R, Dasgupta A, Ward M. Predicting Major Treatment Response to Tumor Necrosis Factor Inhibitors in Patients with Ankylosing Spondylitis [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/predicting-major-treatment-response-to-tumor-necrosis-factor-inhibitorsin-patients-with-ankylosing-spondylitis/.
4540Chris GaleUniversity of LeedsEfficacy and safety of edoxaban versus warfarin in patients with atrial fibrillation and frailty insights from the ENGAGE AF-TIMI 48 trialWilkinson, C., Wu, J., Searle, S.D. et al. Clinical outcomes in patients with atrial fibrillation and frailty: insights from the ENGAGE AF-TIMI 48 trial. BMC Med 18, 401 (2020).

https://doi.org/10.1186/s12916-020-01870-w
5933, 5208Ahmad AbuhelwaUniversity of South Australia Predictors of exposure, therapeutic and adverse effects of certolizumab pegol, baricitinib and tocilizumab used in the treatment of rheumatoid arthritisAbuhelwa, A.Y., Hopkins, A.M., Sorich, M.J. et al. Association between obesity and remission in rheumatoid arthritis patients treated with disease-modifying anti-rheumatic drugs. Sci Rep 10, 18634 (2020).

https://doi.org/10.1038/s41598-020-75673-7
4327Michael SzarekSUNY Downstate Medical CenterAnalysis of Total Events and Hospitalizations in the SPARCL StudySzarek M, Amarenco P, Callahan A, DeMicco D, Fayyad R, Goldstein LB, Laskey R, Sillesen H, Welch KM; SPARCL Committees and Investigators. Atorvastatin Reduces First and Subsequent Vascular Events Across Vascular Territories: The SPARCL Trial. J Am Coll Cardiol. 2020 May 5;75(17):2110-2118. doi: 10.1016/j.jacc.2020.03.015. Epub 2020 Mar 16.

PMID: 32194196
4116Sharon StrausSt. Michael's HospitalComparative safety and effectiveness of cognitive enhancers for Alzheimer's dementia a systematic review and individual patient data network meta-analysisVeroniki AA, Ashoor H, Rios P, Seitidis G, Mavridis D, Holroyd-Leduc J, Straus S, Tricco A. Comparative safety and efficacy of cognitive enhancers for Alzheimer’s dementia: An individual patient data network meta-analysis. In: Advances in Evidence Synthesis: special issue. Cochrane Database of Systematic Reviews 2020;(9 Suppl 1):455.

https://doi.org/10.1002/14651858.CD202001

PUBLICATIONS ABOUT DATA SHARING

Timely access to trial data in the context of a pandemic: the time is now.

Li R, Wood J, Baskaran A, et al. Timely access to trial data in the context of a pandemic: the time is now. BMJ Open 2020; 10:e039326. doi: 10.1136/bmjopen-2020-039326
Move clinical trial data sharing from an option to an imperative

New NonProfit Aims To Bring Data Transparency To Researchers

PRESENTATIONS

April 24, 2020"Sharing, Discovering and Citing COVID-19 Data and Code."National Library of Medicine (NLM) at the National Institutes of Health (NIH)
Ida Sim, MD, PhD
February 11, 2020"Vivli Clinical Research Data Sharing: Share. Discover. Innovate." NIH Workshop on the Role of Generalist Repositories to Enhance Data Discoverability and Reuse, Bethesda MD
Ida Sim, MD, PhD
October 25, 2019 “Finding New Solutions to Problems and Concerns in Clinical Data Sharing – Outcomes from Datathon."DIA Future of Evidence WorkshopRebecca Li, PhD
October 10, 2019 "Clinical Trial Data Sharing and Reuse: A New Reality for Researchers." > Clinical Data Interchange Standards Consortium WebinarIda Sim, MD, PhD
Rebecca Li, PhD
September 27 2019 "Preparing for clinical trial data sharing and re-use: the new reality for researchers." NIH Collaboratory Grand RoundsRebecca Li, PhD
Frank Rockhold, PhD
September 19, 2019“The Vivli Experience in Sharing Clinical Trial Data Globally.”OHRP Exploratory Workshop: Privacy & Health Research in a Data-Driven WorldRebecca Li, PhD
June 2019“Symposium SY13: Data sharing and responsible conduct of research: sharing industry experiences as part of the research transparency environment."World Conference in Research Integrity, Hong KongRebecca Li, PhD
March 27, 2019“Vivli: A Global Secure Data-Sharing Platform for Participant-Level Clinical Trial Data." Medical Informatics Association Summit, San Francisco CAIda Sim, MD, PhD
January 30, 2019“The Disclosure and Data Sharing Lifecycle.” CBI Clinical Data Disclosure and Transparency Conference, Philadelphia PAJulie Wood
Thomas Wicks (TrialScope)
October 25, 2018 "Sharing and Using Deidentified Individual Participant Data (IPD)." DIA Global Clinical Trials Transparency Conference, LondonRebecca Li, PhD
March 13, 2018“Vivli: A Global Secure Data Sharing Platform for Participant-level Clinical Trial Data.” American Medical Informatics Association Summit, San Francisco CAIda Sim, MD, PhD
November 17, 2017 “Acceleration of Innovation to Overcome Intractable Diseases." Academic Research Organization’s 2nd Global Network Workshop, Austin TXIda Sim, MD, PhD