PUBLICATIONS FROM RESEARCH PROPOSALS
The table provides details of approved research proposals that have published or presented their results.
| Data Request ID | Lead Investigator | Institution | Research Proposal Title | Publication |
|---|---|---|---|---|
| 4036 | Akira Kimata | University of Tsukuba | Optimal interruption time of dabigatran per OS to Ablation (O-A time) in patients with atrial fibrillation Integrated analysis of 2 randomized controlled clinical trials | Circulation. 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 |
| 3320 | John Frew | Rockefeller University | Analysis of Outcome Measures in Hidradenitis Suppurativa | Clinical 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 |
| 4117 | John Frew | Rockefeller University | Predictors 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 |
| 4319 | Maria Alice Franzoi | Jules 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 trials | 153P 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 |
| 4319 | Maria Alice Franzoi | Jules Bordet Institut | Clinical implications of body mass index in metastatic breast cancer patients treated with abemaciclib and endocrine therapy | Maria 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 |
| 3320 | John Frew | Rockefeller University | Analysis of Outcome Measures in Hidradenitis Suppurativa | Frew, 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 |
| 5327 | Jose Antonio Pereira da Silva | Universidade de Coimbra, Portugal | Long-term predictive value of patient global assessment regarding radiographic damage and physical function in patients with Rheumatoid Arthritis individual patient data meta-analysis | Ferreira 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 |
| 3320 | John Frew | Rockefeller University | Analysis of Outcome Measures in Hidradenitis Suppurativa | Frew 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 |
| 3369 | Michael Ward | National Institutes of Health (NIH) | Predicting Treatment Response to Tumor Necrosis Factor Inhibitors in Patients with Ankylosing Spondylitis | Wang 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/. |
| 4540 | Chris Gale | University of Leeds | Efficacy and safety of edoxaban versus warfarin in patients with atrial fibrillation and frailty insights from the ENGAGE AF-TIMI 48 trial | Wilkinson, 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, 5208 | Ahmad Abuhelwa | University of South Australia | Predictors of exposure, therapeutic and adverse effects of certolizumab pegol, baricitinib and tocilizumab used in the treatment of rheumatoid arthritis | Abuhelwa, 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 |
| 4327 | Michael Szarek | SUNY Downstate Medical Center | Analysis of Total Events and Hospitalizations in the SPARCL Study | Szarek 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 |
| 4116 | Sharon Straus | St. Michael's Hospital | Comparative safety and effectiveness of cognitive enhancers for Alzheimer's dementia a systematic review and individual patient data network meta-analysis | Veroniki 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 Workshop | Rebecca Li, PhD |
| October 10, 2019 | "Clinical Trial Data Sharing and Reuse: A New Reality for Researchers." > Clinical Data Interchange Standards Consortium Webinar | Ida 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 Rounds | Rebecca 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 World | Rebecca 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 Kong | Rebecca Li, PhD |
| March 27, 2019 | “Vivli: A Global Secure Data-Sharing Platform for Participant-Level Clinical Trial Data." Medical Informatics Association Summit, San Francisco CA | Ida Sim, MD, PhD |
| January 30, 2019 | “The Disclosure and Data Sharing Lifecycle.” CBI Clinical Data Disclosure and Transparency Conference, Philadelphia PA | Julie Wood Thomas Wicks (TrialScope) |
| October 25, 2018 | "Sharing and Using Deidentified Individual Participant Data (IPD)." DIA Global Clinical Trials Transparency Conference, London | Rebecca 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 CA | Ida Sim, MD, PhD |
| November 17, 2017 | “Acceleration of Innovation to Overcome Intractable Diseases." Academic Research Organization’s 2nd Global Network Workshop, Austin TX | Ida Sim, MD, PhD |
