The table provides details of approved research proposals that have published or presented their results.
|Data Request ID||Lead Investigator||Institution||Research Proposal Title||Public Disclosure|
|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
|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.
|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),
|3320||John Frew||Rockefeller University||Analysis of Outcome Measures in Hidradenitis Suppurativa||Frew, J. W., Singh, N., Jiang, C. S., Vaughan, R., & Krueger, J. G. (2021). The Impact of Body Mass Index Upon the Efficacy of Adalimumab in Hidradenitis Suppurativa. Frontiers in Medicine.
|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).
|3762||Lin Wang||Johns Hopkins School of Public Health, Johns Hopkins Hospital||The relative efficacy and safety of apalutamide, enzalutamide, abiraterone, and darolutamide for nonmetastatic castration-resistant prostate cancer ||Lin Wang, MD, PhD, Channing Paller, MD, Hwanhee Hong, PhD, Lori Rosman, MLS, Anthony De Felice, MHS, Otis Brawley, MD, G Caleb Alexander, MD, MS, Comparison of Treatments for Nonmetastatic Castration-Resistant Prostate Cancer: Matching-Adjusted Indirect Comparison and Network Meta-Analysis, JNCI: Journal of the National Cancer Institute, 2021;, djab071,
|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)
|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,
|4043||Janneke van der Woude||Erasmus Medical Center||Effect of treatment on lipid profiles in patients with inflammatory bowel disease a systematic review and meta-analysis||J A M Sleutjes, J E Roeters van Lennep, E Boersma, A C de Vries, C J van der Woude, P292 Effect of drug therapy on the lipid profiles of patient with Inflammatory Bowel Disease: a systematic review and meta-analysis, Journal of Crohn's and Colitis, Volume 15, Issue Supplement_1, May 2021, Pages S322–S323.
|4043||Janneke van der Woude||Erasmus Medical Center||Effect of treatment on lipid profiles in patients with inflammatory bowel disease a systematic review and meta-analysis||Sleutjes, JAM, Roeters van Lennep, JE, Boersma, E, et al. Systematic review with meta-analysis: effect of inflammatory bowel disease therapy on lipid levels. Aliment Pharmacol Ther. 2021; 00: 1– 14.
|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.
|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.
|4316||Martin Okun||Fort Healthcare||Geospatial and Seasonal Variation in Psoriasis Severity Analysis of Placebo Response Data from Phase 3 placebo-controlled trials in moderate-severe psoriasis.||268 Analysis of association between variation in ambient solar ultraviolet exposure and disease severity for patients with moderate-severe psoriasis
Okun, T.S. et al.
Journal of Investigative Dermatology, Volume 141, Issue 5, S48
|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.
|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,
|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.
|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.
|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).
|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
|5073||Philip Robinson||University of Queensland||Assessment of treatment outcome using ASAS40 with etanercept in non-radiographic axSpA by baseline CRP - a re-analysis of trial data||Tam, H.K.J., Nash, P. and Robinson, P.C. (2021), The Effect of Etanercept in Nonradiographic Axial Spondyloarthritis by Stratified C-Reactive Protein Levels. ACR Open Rheumatology.
|5086||Junko Takeshita||University of Pennsylvania||A Systematic Review to Describe the Demographic Diversity of Dermatologic Clinical Trial Participants for Common Dermatologic Diseases||560 Racial/ethnic diversity in U.S. clinical trials for acne, atopic dermatitis, and psoriasis
Sevagamoorthy, A. et al.
Journal of Investigative Dermatology, Volume 141, Issue 5, S97
|5095||Mathilde Nijkeuter||University Medical Center Utrecht||Assessing bleeding risk in patients with cancer-associated thrombosis||de Winter MA, Dorresteijn JAN, Ageno W, Ay C, Beyer Westendorf J, Coppens M, Klok FA, Moustafa F, Riva N, C Ruiz Artacho P, Vanassche T, Nijkeuter M. Estimating Bleeding Risk in Patients with Cancer-associated Thrombosis: External Validation of Existing Risk Scores and Development of a New Risk Score [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 1).
https://abstracts.isth.org/abstract/estimating-bleeding-risk-in-patients-with-cancer-associated-thrombosis-external-validation-of-existing-risk-scores-and-development-of-a-new-risk-score/. Accessed July 23, 2021.
|5095||Mathilde Nijkeuter||University Medical Center Utrecht||Assessing bleeding risk in patients with cancer-associated thrombosis||de Winter MA, Dorresteijn JAN, Ageno W, Ay C, Beyer-Westendorf J, Coppens M, Klok FA, Moustafa F, Riva N, Ruiz Artacho PC, Vanassche T, Nijkeuter M. Estimating Bleeding Risk in Patients with Cancer-Associated Thrombosis: Evaluation of Existing Risk Scores and Development of a New Risk Score. Thromb Haemost. 2021 Sep 20.
|5096||Joo Sang Lee||Samsung Medical Center, South Korea||Harnessing genetic interactions to advance precision cancer medicine||Synthetic lethality-mediated precision oncology via the tumor transcriptome. Lee, Joo Sang et al.
Cell, Volume 184, Issue 9, 2487 - 2502.e13.
|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.
|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
|5166||Thomas Metkus||Johns Hopkins University School of Medicine||Severe sepsis in the cardiac intensive care unit: management strategies and outcomes||Feldman, E. W., Dugan, E., Stephens, R. S., Schulman, S., Zakaria, S., & Metkus, T. (2021). Presentation and outcomes of sepsis in the cardiac intensive care unit. American Heart Journal Plus: Cardiology Research and Practice, 7, 100040.
|5207||Fasihul Khan||University of Nottingham||A systematic review and individual patient data meta-analysis of physiological biomarkers in idiopathic pulmonary fibrosis||Khan FA, Stewart I, Saini G, Robinson KA, Jenkins RG. A systematic review of blood biomarkers with individual participant data meta-analysis of matrix-metalloproteinase-7 in IPF. Eur Respir J. 2021 Sep 29:2101612. PMID: 34588192.
|5289, 5323||Ashley Hopkins||Flinders University||Predictors of therapeutic and adverse effects of medicines used in the treatment of breast cancer||Prediction of severe neutropenia and diarrhoea in breast cancer patients treated with abemaciclib. Modi, Natansh D. et al. The Breast, Volume 58, 57 – 62.
|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.
|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.
|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||Sa467 THE MODIFIED MULTIPLIER SES-CD (MM-SES-CD) PERFORMS BETTER THAN THE SES-CD FOR PREDICTION OF ENDOSCOPIC REMISSION IN CROHN'S DISEASE. Narula, Neeraj et al.
Gastroenterology, Volume 160, Issue 6, S-509.
|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.
|5895, 6117||Ashley Hopkins||Flinders University||Predictors of exposure, therapeutic and adverse effects of atezolizumab used in the treatment of advanced cancers||Abuhelwa AY, Kichenadasse G, McKinnon RA, Rowland A, Hopkins AM, Sorich MJ. Machine Learning for Prediction of Survival Outcomes with Immune-Checkpoint Inhibitors in Urothelial Cancer. Cancers. 2021; 13(9):2001.
|5895, 6117||Ashley Hopkins||Flinders University||Predictors of exposure, therapeutic and adverse effects of atezolizumab used in the treatment of advanced cancers||Concomitant Proton Pump Inhibitor Use and Survival in Urothelial Carcinoma Treated with Atezolizumab. Ashley M. Hopkins, Ganessan Kichenadasse, Christos S. Karapetis, Andrew Rowland and Michael J. Sorich.
Clin Cancer Res October 15 2020 (26) (20) 5487-5493;
|5925||Min Hwan Kim||Yonsei University College of Medicine||Analysis of neutrophil to lymphocyte ratio (NLR) in ER+ breast cancer patients to predict palbociclib clinical response||On-treatment derived neutrophil-to-lymphocyte ratio and response to palbociclib and letrozole: Analysis of a multicenter retrospective cohort and the PALOMA-2 study.
Chang Gon Kim, Min Hwan Kim, Jee Hung Kim, Seul-Gi Kim, Gun Min Kim, Tae Yeong Kim, Won-Ji Ryu, Jeeye Kim, Hyung Seok Park, Seho Park, Youngup Cho, Byeong-Woo Park, Seung Il Kim, Joon Jeong, and Joohyuk Sohn. Journal of Clinical Oncology 2021 39:15_suppl, 1066-1066.
|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).
|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 AY, Foster DJR, Manning-Bennett A, et al. Concomitant beta-blocker use is associated with a reduced rate of remission in patients with rheumatoid arthritis treated with disease-modifying anti-rheumatic drugs: a post hoc multicohort analysis. Therapeutic Advances in Musculoskeletal Disease. January 2021.
|5945||Neeraj Narula||McMaster University||Predictors of Mucosal Healing in Ulcerative Colitis: A Post-hoc Analysis of VARSITY||Narula, N., Wong, E., Colombel, J. F., Riddell, R., Marshall, J., Reinisch, W., & Dulai, P. (2021). DOP03 Early change in epithelial neutrophilic infiltrate predicts long-term response to biologics in Ulcerative Colitis. Journal of Crohn’s and Colitis, 15(Supplement_1), S042–S043.
|5945||Neeraj Narula||McMaster University||Predictors of Mucosal Healing in Ulcerative Colitis: A Post-hoc Analysis of VARSITY||Narula, N., Wong, E. C., Colombel, J. F., Riddell, R., Marshall, J. K., Reinisch, W., & Dulai, P. S. (2021). Early Change in Epithelial Neutrophilic Infiltrate Predicts Long-Term Response to Biologics in Ulcerative Colitis. Clinical Gastroenterology and Hepatology. Published.
|5951||Mathilde Nijkeuter||University Medical Center Utrecht||Individualized prediction of recurrence risk reduction and risk of bleeding with extended anticoagulation in patients with venous thromboembolism||de Winter MA, Dorresteijn JAN, Carrier M, Cohen AT, Hansen J-, Kaasjager HAH, Middeldorp S, Raskob GE,Sørensen HT, Visseren FLJ, Wells PS, Büller HR, Nijkeuter M. Individual Benefits and Harms of Extended Anticoagulation in Patients with Venous Thromboembolism: The VTE-PREDICT Model [abstract]. Res PractThromb Haemost. 2021; 5 (Suppl 1).
https://abstracts.isth.org/abstract/individual-benefi ts-and-harms-of-extended-anticoagulation-in-patients-with-venous-thromboembolism-the-vte-predict-model/. Accessed July 23, 2021.
|6064||Neeraj Narula||Hamilton Health Sciences||Comparative Effectiveness of Vedolizumab vs. Infliximab in Ulcerative Colitis||Narula N, Wong ECL, Marshall JK, Colombel JF, Dulai PS, Reinisch W. Comparative Efficacy for Infliximab Vs Vedolizumab in Biologic Naive Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Jul 28:S1542-3565(21)00820-X. PMID: 34329776.