PUBLIC DISCLOSURES 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 |
|---|---|---|---|---|
| 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 |
| 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 |
| 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/. |
| 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 |
| 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 | Akira Kimata, Akihiko Nogami, Hiro Yamasaki, Tomohiro Ohigashi, Masahiko Gosho, Miyako Igarashi, Yukio Sekiguchi, Masaki Ieda, Hugh Calkins, Kazutaka Aonuma, Optimal interruption time of dabigatran oral administration to ablation (O-A time) in patients with atrial fibrillation: Integrated analysis of 2 randomized controlled clinical trials, Journal of Cardiology, 2021, ISSN 0914-5087, https://doi.org/10.1016/j.jjcc.2020.12.010 |
| 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 |
| 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 |
| 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 |
| 4330 | Laure Gossec | Sorbonne Université | Domains of health important for Rheumatoid Arthritis patients can be assessed separately: Reliability and Responsiveness of the Rheumatoid Arthritis Impact of Disease Score - 7 items (RAID.7i) | Duarte C, Santos EJF, Ferreira RJO, et al. Validity and reliability of the EULAR instrument RAID.7 as a tool to assess individual domains of impact of disease in rheumatoid arthritis: a cross-sectional study of 671 patients RMD Open 2021;7:e001539. doi: 10.1136/rmdopen-2020-001539 |
| 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 |
| 4918 | Nina Hilkens | Radboudumc Nijmegen | Association between blood pressure, blood pressure variability and the risk of post-stroke dementia | Hilkens, Nina A.; Klijn, Catharina J.M.; Richard, Edo Blood pressure, blood pressure variability and the risk of poststroke dementia, Journal of Hypertension: March 11, 2021 - Volume Publish Ahead of Print - Issue doi: 10.1097/HJH.0000000000002841 |
| 5163 | Susan Bates | Columbia University Medical Center | Assessing the tumor growth and decay rates in patients with pancreatic cancer treated with Gemcitabine/Abraxane: Comparing real world data with clinical trial data | Keith Sigel, Mengxi Zhou, Yeun-Hee Anna Park, Tinaye Mutetwa, Girish Nadkarni, Celine Yeh, Paz Polak, Carlie Sigel, Thierry Conroy, Béata Juzyna, Mark Ychou, Tito Fojo, Juan P Wisnivesky, Susan E. Bates, Gemcitabine plus nab-paclitaxel versus FOLFIRINOX for unresected pancreatic cancer: Comparative effectiveness and evaluation of tumor growth in veterans, Seminars in Oncology, 2021, ISSN 0093-7754. https://doi.org/10.1053/j.seminoncol.2021.02.001 |
| 5166 | Thomas Metkus | Johns Hopkins University School of Medicine | Severe sepsis in the cardiac intensive care unit: management strategies and outcomes | Dugan, Eunice; Stephens, R. Scott; Schulman, Steven; Metkus, Thomas 1205: Sepsis in the Cardiac Intensive Care Unit: Demographics and Outcomes, Critical Care Medicine: January 2021 - Volume 49 - Issue 1 - p 605 doi: 10.1097/01.ccm.0000730708.28818.5e |
| 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 |
| 5567 | Neeraj Narula | McMaster University | Impact of Ulcer Size and Extent of Inflammation On Ability To Achieve Endoscopic Healing In Crohn’s Disease: An EXTEND Post-Hoc Analysis | Narula N, Wong ECL, Colombel J, et alPredicting endoscopic remission in Crohn’s disease by the modified multiplier SES-CD (MM-SES-CD) Gut Published Online First: 25 March 2021. doi: 10.1136/gutjnl-2020-323799 |
| 5895, 6117 | Ashley Hopkins | Flinders University | Predictors of exposure, therapeutic and adverse effects of atezolizumab used in the treatment of advanced cancers | Hopkins AM, Kichenadasse G, Abuhelwa AY, McKinnon RA, Rowland A, Sorich MJ. Value of the Lung Immune Prognostic Index in Patients with Non-Small Cell Lung Cancer Initiating First-Line Atezolizumab Combination Therapy: Subgroup Analysis of the IMPOWER150 Trial. Cancers. 2021; 13(5):1176. https://doi.org/10.3390/cancers13051176 |
| 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 |
PUBLICATIONS ABOUT DATA SHARING
 | COVID-19 trials: declarations of data sharing intentions at trial registration and at publication Li, R., von Isenburg, M., Levenstein, M. et al. COVID-19 trials: declarations of data sharing intentions at trial registration and at publication. Trials 22, 153 (2021). https://doi.org/10.1186/s13063-021-05104-z |
 | 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 |
