Center for Global Research Data

Public Disclosures

These tables provide details of approved research proposals that have published or presented their results.

2022

Data Request IDLead InvestigatorInstitutionResearch Proposal TitlePublic DisclosureData Contributor(s)
3369Michael WardNational Institutes of Health (NIH) Predicting Treatment Response to Tumor Necrosis Factor Inhibitors in Patients with Ankylosing SpondylitisWang R, Dasgupta A, Ward MM. Predicting Probability of Response to Tumor Necrosis Factor Inhibitors for Individual Patients With Ankylosing Spondylitis. JAMA Netw Open. 2022;5(3):e222312.

doi: 10.1001/jamanetworkopen.2022.2312
AbbVie, Pfizer
4116Sharon StraussSt. 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 HM, Rios P, et al. Comparative safety and efficacy of cognitive enhancers for Alzheimer’s dementia: a systematic review with individual patient data network meta-analysis BMJ Open 2022;12:e053012.

doi: 10.1136/bmjopen-2021-053012
AbbVie
4316Martin OkunFort HealthcareGeospatial and Seasonal Variation in Psoriasis Severity Analysis of Placebo Response Data from Phase 3 placebo-controlled trials in moderate-severe psoriasis.Okun TSD, Okun MM. No Evidence that Variations in Ambient Solar Ultraviolet Radiation and Psoriasis Severity are Associated. Journal of Psoriasis and Psoriatic Arthritis. January 2022.

doi: 10.1177/24755303221079810
AbbVie
4326John MarkmanUniversity of RochesterPhenotypic Characterization of Chronic Neuropathic Pain Following Post-Traumatic and Post-Surgical InjuryGewandter JS, Sohn MB, De Guzman R, Frazer ME, Chiodo V, Sharma S, Geha P, Markman JD. Predicting treatment response with sensory phenotyping in post-traumatic neuropathic pain. Pain Med. 2022 Mar 21:pnac045. PMID: 35312012.

doi: 10.1093/pm/pnac045
Pfizer
4329Shomron Ben-HorinSun Yatsen 1st affiliated HospitalEfficacy of biologic drugs in short-duration versus long-duration inflammatory bowel diseaseShomron Ben-Horin, Lena Novack, Ren Mao, Jing Guo, Yue Zhao, Ruslan Sergienko, Jian Zhang, Taku Kobayashi, Toshifumi Hibi, Yehuda Chowers, Laurent Peyrin-Biroulet, Jean Frederic Colombel, Gilaad G. Kaplan, Min-hu Chen. Efficacy of biologic drugs in short-duration versus long-duration inflammatory bowel disease: A systematic review and an individual-patient data meta-analysis of randomized controlled trials. Gastroenterology, 2021, ISSN 0016-5085.

doi: 10.1053/j.gastro.2021.10.037
AbbVie, Biogen, Johnson & Johnson, Takeda, UCB
4921Tim BrümmendorfUniversity Hospital AachenEntropy-based Biomarkers for individualized response on Bosutinib treatment in chronic phase CMLEsfahani, Ali, Susanne Isfort, Tim Brümmendorf, and Andreas Schuppert. Entropy-based Biomarkers for Individualized Response on Bosutinib Treatment in Chronic Phase CML. OSF Preprints. March 1, 2022.

doi:10.31219/osf.io/bu2qy
Pfizer
5098Christopher BaethgeUniversity of Cologne Medical SchoolDose-response relationships in antidepressant pharmacotherapy of depressive disorders with (S)SNRI: a systematic review and meta-analysisRink L, Adams A, Braun C, Bschor T, Kuhr K, Baethge C. Dose-Response Relationship in Selective Serotonin and Norepinephrine Reuptake Inhibitors in the Treatment of Major Depressive Disorder: A Meta-Analysis and Network Meta-Analysis of Randomized Controlled Trials. Psychother Psychosom 2021.

doi: 10.1159/000520554
Lilly
5165Byeongzu GhangJeju National University HospitalReanalysis of CARES study to investigate the incidence of cardiovascular events and death after initiation and discontinuation of allopurinol and febuxostatGhang B, Lee JS, Choi J, et al. Increased risk of cardiovascular events and death in the initial phase after discontinuation of febuxostat or allopurinol: another story of the CARES trial. RMD Open 2022;8:e001944

doi: 10.1136/rmdopen-2021-001944
Takeda
5207Fasihul KhanUniversity of NottinghamA systematic review and individual patient data meta-analysis of physiological biomarkers in idiopathic pulmonary fibrosisKhan FA, Stewart I, Moss S, Fabbri L, Robinson KA, Johnson SR, Jenkins RG. Three-Month FVC Change: A Trial Endpoint for IPF Based on Individual Participant Data Meta-Analysis. Am J Respir Crit Care Med. 2022 Jan 12.

doi: 10.1164/rccm.202109-2091OC
BioLINCC, Boehringer Ingelheim, Johnson & Johnson, Roche
5291Sarah NevittUniversity of LiverpoolAntiepileptic drug monotherapy for epilepsy: an updated Cochrane review and individual participant data network meta-analysisNevitt SJ, Sudell M, Cividini S, Marson AG, Tudur Smith C. Antiepileptic drug monotherapy for epilepsy: a network meta‐analysis of individual participant data. Cochrane Database of Systematic Reviews 2022, Issue 4. Art. No.: CD011412.

doi: 10.1002/14651858.CD011412.pub4
UCB
5352Elena MyasoedovaMayo ClinicIndividualized Prediction of Treatment Response to Methotrexate in Patients with Rheumatoid Arthritis: A Machine Learning ApproachDuong, S.Q., Crowson, C.S., Athreya, A., Atkinson, E.J., Davis, J.M., Warrington, K.J., Matteson, E.L., Weinshilboum, R., Wang, L. and Myasoedova, E. Clinical predictors of response to methotrexate in patients with rheumatoid arthritis: a machine learning approach using clinical trial data. Arthritis Res Ther 24, 162 (2022).

doi: 10.1186/s13075-022-02851-5
Roche, UCB
5352Elena MyasoedovaMayo ClinicIndividualized Prediction of Treatment Response to Methotrexate in Patients with Rheumatoid Arthritis: A Machine Learning ApproachDuong S, Crowson CS, Athreya A, et al. POS0514 PREDICTION OF RESPONSE TO METHOTREXATE IN PATIENTS WITH RHEUMATOID ARTHRITIS: A MACHINE LEARNING APPROACH USING CLINICAL TRIAL DATA. Annals of the Rheumatic Diseases 2022;81:513-514.

doi:10.1136/annrheumdis-2022-eular.891
Roche, UCB
5812Yougen WuThe Fifth People's Hospital of Shanghai, Fudan UniversityDevelopment and validation of nomograms for predicting efficacy and toxicity in cancer patients treated with immune checkpoint inhibitorsWu Y, Zhu W, Wang J, Liu L, Zhang W, Wang Y, Shi J, Xia J, Gu Y, Qian Q, Hong Y. Using machine learning for mortality prediction and risk stratification in atezolizumab-treated cancer patients: Integrative analysis of eight clinical trials. Cancer Med. 2022 Jul 24.

doi: 10.1002/cam4.5060
Roche
5853Florian NaudetCHU RennesData-sharing and re-analysis for main studies assessed by the European Medicines Agency - a cross-sectional study on European Public Assessment ReportsSiebert, M., Gaba, J., Renault, A. et al. Data-sharing and re-analysis for main studies assessed by the European Medicines Agency—a cross-sectional study on European Public Assessment Reports. BMC Med 20, 177 (2022).

doi:10.1186/s12916-022-02377-2
AbbVie
5895, 6117Ashley HopkinsFlinders UniversityPredictors of exposure, therapeutic and adverse effects of atezolizumab used in the treatment of advanced cancerssAhmad Y Abuhelwa, Joaquim Bellmunt, Ganessan Kichenadasse, Ross A McKinnon, Andrew Rowland, Michael J Sorich, Ashley M Hopkins. Enhanced Bellmunt risk score for survival prediction in urothelial carcinoma treated with immunotherapy. Clinical Genitourinary Cancer, 2021.

doi: 10.1016/j.clgc.2021.11.010
Roche
5895, 6117Ashley HopkinsFlinders UniversityPredictors of exposure, therapeutic and adverse effects of atezolizumab used in the treatment of advanced cancersEugene Tan, Ahmad Y. Abuhelwa, Sarah Badaoui, Natansh D. Modi, Michael D. Wiese, Ross A. McKinnon, Michael J. Sorich and Ashley M. Hopkins. Association Between Patient-Reported Outcomes and Survival in Patients with Advanced Urothelial Carcinoma Treated with Atezolizumab. 1 Jan, 2021 : 1

doi: 10.3233/BLC-211613
Roche
5895, 6117Ashley HopkinsFlinders UniversityPredictors of exposure, therapeutic and adverse effects of atezolizumab used in the treatment of advanced cancersBadaoui S, Shahnam A, McKinnon RA, Abuhelwa AY, Sorich MJ, Hopkins AM. The predictive utility of patient-reported outcomes and performance status for survival in metastatic lung cancer patients treated with chemoimmunotherapy. Transl Lung Cancer Res 2022;11(3):432-439.

doi: 10.21037/tlcr-21-9385
Roche
5895, 6117Ashley HopkinsFlinders UniversityPredictors of exposure, therapeutic and adverse effects of atezolizumab used in the treatment of advanced cancersHopkins, A. M., Badaoui, S., Kichenadasse, G., Karapetis, C. S., McKinnon, R. A., Rowland, A., & Sorich, M. J. (2022). Efficacy of Atezolizumab in Patients With Advanced NSCLC Receiving Concomitant Antibiotic or Proton Pump Inhibitor Treatment: Pooled Analysis of Five Randomized Control Trials. Journal of Thoracic Oncology.

doi: https://doi.org/10.1016/j.jtho.2022.02.003
Roche
5895, 6117Ashley HopkinsFlinders UniversityPredictors of exposure, therapeutic and adverse effects of atezolizumab used in the treatment of advanced cancersAbuhelwa AY, Bellmunt J, Kichenadasse G, McKinnon RA, Rowland A, Sorich MJ, Hopkins AM. C-reactive protein provides superior prognostic accuracy than the IMDC risk model in renal cell carcinoma treated with Atezolizumab/Bevacizumab. Front Oncol. 2022 Aug 1;12:918993.

doi: 10.3389/fonc.2022.918993
Roche
5933Ahmad AbuhelwaPredictors of exposure, therapeutic and adverse effects of certolizumab pegol, baricitinib and tocilizumab used in the treatment of rheumatoid arthritisPredictors of exposure, therapeutic and adverse effects of certolizumab pegol and baricitinib used in the treatment of rheumatoid arthritisManning-Bennett, A. T., Hopkins, A. M., Sorich, M. J., Proudman, S. M., Foster, D. J. R., Abuhelwa, A. Y., & Wiese, M. D. (2022). The association of depression and anxiety with treatment outcomes in patients with rheumatoid arthritis – a pooled analysis of five randomised controlled trials. Therapeutic Advances in Musculoskeletal Disease.

doi:10.1177/1759720X221111613
Roche
5935Jian-Guo ZhouThe Second Affiliated Hospital of Zunyi Medical UniversityLongitudinal peripheral blood markers as dynamic predictors to identify efficacy and safety of patients treated with immune checkpoint inhibitors (ICIs)Zhou J, Yang J, Wang H, et al. Machine learning based on blood biomarkers predicts fast progression in advanced NSCLC patients treated with immunotherapy. Annals of Oncology (2022) 33 (suppl_2): S27-S70.

doi: 10.1016/j.annonc.2022.02.069
Roche
5935Jian-Guo ZhouThe Second Affiliated Hospital of Zunyi Medical UniversityLongitudinal peripheral blood markers as dynamic predictors to identify efficacy and safety of patients treated with immune checkpoint inhibitors (ICIs)Ma, SC., Bai, X., Guo, XJ., Liu, L., Xiao, LS., Lin, Y., Tan, JL., Cai, XT., Wen, YX., Ma, H., Fu, QJ., Leng, MX., Zhang, YP., Long, LL., Guo, ZQ., Wu, DH., Zhou, JG., Dong, ZY. Organ-specific metastatic landscape dissects PD-(L)1 blockade efficacy in advanced non-small cell lung cancer: applicability from clinical trials to real-world practice. BMC Med 20, 120 (2022).

doi: 10.1186/s12916-022-02315-2
Roche
5935Jian-Guo ZhouThe Second Affiliated Hospital of Zunyi Medical UniversityLongitudinal peripheral blood markers as dynamic predictors to identify efficacy and safety of patients treated with immune checkpoint inhibitors (ICIs)Development and validation of longitudinal c-reactive protein as dynamic response predictor for PD-L1 blockade in advanced NSCLC: Findings from four atezolizumab clinical trials. Jian-Guo Zhou, Xiaofei Chen, Ada Hang-Heng Wong, Haitao Wang, Fangya Tan, Si-Si He, Gang Shen, YunJia Wang, Ruihong Wang, Shamus R. Carr, Benjamin Frey, Rainer Fietkau, Markus Hecht, Hu Ma, David S. Schrump, and Udo S Gaipl. Journal of Clinical Oncology 2022 40:16_suppl, e21113-e21113.

doi: 10.1200/JCO.2022.40.16_suppl.e21113.
Roche
5935Jian-Guo ZhouThe Second Affiliated Hospital of Zunyi Medical UniversityLongitudinal peripheral blood markers as dynamic predictors to identify efficacy and safety of patients treated with immune checkpoint inhibitors (ICIs)Zhou, J.G., Wong, A.H.H., Wang, H., Tan, F., Chen, X., Jin, S.H., He, S., Shen, G., Wang, Y.J., Frey, B. and Fietkau, R. Elucidation of the application of blood test biomarkers to predict immune-related adverse events (irAEs) in atezolizumab-treated NSCLC patients by using machine learning methods. Frontiers in Immunology, p.3081.

doi: 10.3389/fimmu.2022.862752
Roche
5935Jian-Guo ZhouThe Second Affiliated Hospital of Zunyi Medical UniversityLongitudinal peripheral blood markers as dynamic predictors to identify efficacy and safety of patients treated with immune checkpoint inhibitors (ICIs)Zhou J, Wong A, Wang H, Jin S, Tan F, Chen Y, He S, Shen G, Frey B, Fietkau R, Hecht M, Carr S, Wang R, Shen B, Schrump D, Ma H and Gaipl US(2022) Definition of a new blood cell count (BCT) score for early survival prediction for non-small cell lung cancer patients treated with atezolizumab: Integrated analysis of 4 multicenter clinical trials. Front. Immunol. 13:961926.

doi:10.3389/fimmu.2022.961926
Roche
5945Neeraj Narula Hamilton Health SciencesPredictors of Mucosal Healing in Ulcerative Colitis: A Post-hoc Analysis of VARSITYNarula, 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.

doi: 10.1016/j.cgh.2021.07.005
Takeda
5984David BakerQueen Mary University of LondonExploring possibilities to improve the risk benefit balance through analysis of the ocrelizumab phase II extension studyBaker, D., MacDougall, A., Kang, A. S., Schmierer, K., Giovannoni, G., & Dobson, R. (2022). CD19 B cell repopulation after ocrelizumab, alemtuzumab and cladribine: Implications for SARS-CoV-2 vaccinations in multiple sclerosis. Multiple Sclerosis and Related Disorders, 57, 103448.

doi: 10.1016/j.msard.2021.103448
Roche
6004Lily LimUniversity of ManitobaIdentifying Trajectories of Disease Activity States in Juvenile Idiopathic Arthritis (JIA) Early After Treatment: Shortening Time to Decision to Change TreatmentLim LSH, Shobhan S, Lokku A, Ringold S, Pullenayegum E. Latent classes of early response trajectories to biologics initiation in juvenile idiopathic arthritis: an analysis of four trials. Pediatr Rheumatol Online J. 2022 Jul 30;20(1):57.

doi: 10.1186/s12969-022-00719-1
Roche
6004Lily LimUniversity of ManitobaIdentifying Trajectories of Disease Activity States in Juvenile Idiopathic Arthritis (JIA) Early After Treatment: Shortening Time to Decision to Change TreatmentLim, L. S. H., Lokku, A., Pullenayegum, E., & Ringold, S. Probability of Response in the First 16 Weeks After Starting Biologics: An Analysis of Juvenile Idiopathic Arthritis Biologics Trials. Arthritis Care & Research.

doi: 10.1002/acr.25003
Roche
6006Nicholas WhiteMahidol UniversityA Multiple-Dose Study to Assess the Effects of Azithromycin plus Chloroquine on Electrocardiograms in Healthy Subjects - COVID-19Chotsiri, P., Tarning, J., Hoglund, R.M., Watson, J. and White, N.J. (2022), Pharmacometric and electrocardiographic evaluation of chloroquine and azithromycin in healthy volunteers. Clin Pharmacol Ther.

doi:10.1002/cpt.2665
Pfizer
6007Judith GoldsteinJohns Hopkins School of MedicineNational Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Calibrations for Low Vision Patients with age-related macular degeneration (AMD)Judith E. Goldstein, Chris Bradley, Alden L. Gross, Marylou Jackson, Neil Bressler, Robert W. Massof; The NEI VFQ-25C: Calibrating Items in the National Eye Institute Visual Function Questionnaire-25 to Enable Comparison of Outcome Measures. Trans. Vis. Sci. Tech. 2022;11(5):10.


doi: 10.1167/tvst.11.5.10.
Roche
6041Neeraj NarulaHamilton Health SciencesHistologic Predictors of Endoscopic Healing in Crohn's DiseaseEmily C L Wong, BHSc, Arif Yusuf, MD, Jagoda Pokryszka, MD, Parambir S Dulai, MD, Jean-Frederic Colombel, MD, John K Marshall, MD, MSc, Walter Reinisch, MD, PhD, Neeraj Narula, MD, MPH. Increased Expression of Interleukin-13 Receptor in Ileum Associated With Nonresponse to Adalimumab in Ileal Crohn’s Disease. Inflammatory Bowel Diseases. 2022, izac157.

doi: 10.1093/ibd/izac157
AbbVie
6064Neeraj NarulaHamilton Health SciencesComparative Effectiveness of Vedolizumab vs. Infliximab in Ulcerative ColitisNarula 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.

doi: 10.1016/j.cgh.2021.07.038
Johnson & Johnson, Takeda
6494Maria Alice FranzoiJules Bordet InstituteImplications of body mass index on the biological and clinical effects of endocrine therapy and abemaciclib in the neoadjuvant settingFranzoi MA, Lambertini M, Ceppi M, Bruzzone M, de Azambuja E. Implication of body mass index (BMI) on the biological and clinical effects of endocrine therapy plus abemaciclib as neoadjuvant therapy for early breast cancer patients. Breast Cancer Res Treat. 2022 Jan 25.

doi: 10.1007/s10549-022-06525-3.
Lilly
6494Maria Alice FranzoiJules Bordet InstituteImplications of body mass index on the biological and clinical effects of endocrine therapy and abemaciclib in the neoadjuvant settingMaria Alice Franzoi, Matteo Lambertini, Marcello Ceppi, Marco Bruzonne, Evandro de Azambuja. Abstract P5-13-07: Implications of body mass index (BMI) on the biological and clinical effects of endocrine therapy and abemaciclib in the neoadjuvant setting. Cancer Res, 15 February 2022; 82 (4_Supplement): P5–13–07.

doi: 10.1158/1538-7445.SABCS21-P5-13-07
Lilly
6499, 5323, 5289Ashley HopkinsFlinders UniversityPredictors of therapeutic and adverse effects of medicines used in the treatment of breast cancerN.D. Modi, N.O. Danell, R.N.A. Perry, A.Y. Abuhelwa, A. Rathod, S. Badaoui, R.A. McKinnon, M. Haseloff, A. Shahnam, S.M. Swain, M. Welslau, M.J. Sorich, A.M. Hopkins, "Patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced HER2-positive breast cancer", ESMO Open, Volume 7, Issue 3, 2022, 100475.

doi:10.1016/j.esmoop.2022.100475
AstraZeneca, Boehringer Ingelheim, Lilly, Pfizer, Roche
6543Andreas MeidHeidelberg University HospitalReproducible Machine Learning (ML) for Tumor Growth Inhibition (TGI) – can ML methods support the validity of conventional TGI metrics?Meid, A., Gerharz, A., Groll, A. Machine learning for tumor growth inhibition: Interpretable predictive models for transparency and reproducibility. CPT: Pharmacometrics & Systems Pharmacology. 2022 Feb 01.

doi: 10.1002/psp4.12761
Roche
6732Yung-Chuan HuangFu Jen Catholic University HospitalDecision Tree Model for Dose Selection of Dabigatran in Non-valvular Atrial Fibrillation PatientsHuang Y-C, Cheng Y-C, Jhou M-J, Chen M, Lu C-J. Important Risk Factors in Patients with Nonvalvular Atrial Fibrillation Taking Dabigatran Using Integrated Machine Learning Scheme—A Post Hoc Analysis. Journal of Personalized Medicine. 2022; 12(5):756.

doi:10.3390/jpm12050756
Boehringer Ingelheim
7074Gregory YH LipUniversity of LiverpoolImpact of atrial fibrillation and the effects of comorbidities and treatment on disease progression and outcomesDing, W.Y., Calvert, P., Gupta, D. et al. Impact of early ablation of atrial fibrillation on long-term outcomes: results from phase II/III of the GLORIA-AF registry. Clin Res Cardiol (2022).

doi:10.1007/s00392-022-02022-1
Boehringer Ingelheim
7074Gregory YH LipUniversity of LiverpoolImpact of atrial fibrillation and the effects of comorbidities and treatment on disease progression and outcomesRomiti GF, Proietti M, Bonini N, Ding WY, Boriani G, Huisman MV, Lip GYH; GLORIA-AF Investigators. Clinical Complexity Domains, Anticoagulation, and Outcomes in Patients with Atrial Fibrillation: A Report from the GLORIA-AF Registry Phase II and III. Thromb Haemost. 2022 Aug 29.

doi: 10.1055/s-0042-1756355
Boehringer Ingelheim
7077Neeraj NarulaHamilton Health SciencesDominant Patient Reported Outcomes on Predicting Mucosal Healing in Crohn’s DiseaseWong, EC, Dulai, PS, Marshall, JK, Jairath, V, Reinisch, W, Narula, N. Resolution of dominant patient-reported outcome at end of induction predicts clinical and endoscopic remission in Crohn’s disease. Aliment Pharmacol Ther. 2022; 00: 1– 9.

doi: 10.1111/apt.16805
AbbVie, Johnson & Johnson
7077Neeraj NarulaHamilton Health SciencesDominant Patient Reported Outcomes on Predicting Mucosal Healing in Crohn’s DiseaseN Narula, C Pray, E Wong, J F Colombel, J Marshall, M Daperno, W Reinisch, P Dulai. DOP16 Categorizing endoscopic severity of Crohn’s Disease using the Modified Multiplier SES-CD (MM-SES-CD). Journal of Crohn's and Colitis, Volume 16, Issue Supplement_1, January 2022, Pages i065–i066.

doi: 10.1093/ecco-jcc/jjab232.055
AbbVie, Johnson & Johnson
7077Neeraj NarulaHamilton Health SciencesDominant Patient Reported Outcomes on Predicting Mucosal Healing in Crohn’s DiseaseNeeraj Narula, Cara Pray, Emily C L Wong, Jean-Frederic Colombel, John K Marshall, Marco Daperno, Walter Reinisch, Parambir S Dulai. Categorising Endoscopic Severity of Crohn’s Disease Using the Modified Multiplier SES-CD [MM-SES-CD]. Journal of Crohn's and Colitis, 2022;, jjac018,.

doi: 10.1093/ecco-jcc/jjac018
AbbVie, Johnson & Johnson
7126Alessio CortelliniImperial College LondonThe predictive role of inflammation indices in patients treated with immunotherapy or chemotherapy for advanced non-small cell lung cancerDifferential prognostic effect of systemic inflammation in patients with NSCLC treated with immunotherapy or chemotherapy: A post hoc analysis of the phase III OAK trial. Alessio Cortellini, Biagio Ricciuti, Hossein Borghaei, Abdul Rafeh Naqash, Antonio D'Alessio, Claudia A.M. Fulgenzi, Alfredo Addeo, Giuseppe Luigi L. Banna, and David J. James Pinato. Journal of Clinical Oncology 2022 40:16_suppl,

9056-9056. doi:10.1200/JCO.2022.40.16_suppl.9056
Roche
7126Alessio CortelliniImperial College LondonThe predictive role of inflammation indices in patients treated with immunotherapy or chemotherapy for advanced non-small cell lung cancerCortellini, A., Ricciuti, B., Borghaei, H., Naqash, A.R., D'Alessio, A., Fulgenzi, C.A.M., Addeo, A., Banna, G.L. and Pinato, D.J. (2022), Differential prognostic effect of systemic inflammation in patients with non–small cell lung cancer treated with immunotherapy or chemotherapy: A post hoc analysis of the phase 3 OAK trial. Cancer.

doi: 10.1002/cncr.34348
Roche
7158Neeraj NarulaHamilton Health SciencesPatient Reported Symptoms as Predictors of Endoscopic Improvement in Ulcerative ColitisEmily Chu Lee Wong, Badar Hasan, Parambir S. Dulai, John K. Marshall, Walter Reinisch & Neeraj Narula. (2022). End of induction patient reported outcomes predict clinical remission and endoscopic improvement with vedolizumab and adalimumab in ulcerative colitis. Scandinavian Journal of Gastroenterology.

DOI: 10.1080/00365521.2022.2105169
Takeda
7159James SignorovitchAnalysis GroupAssociations between steroid treatment, functional outcomes and disease milestones among non-ambulatory patients with Duchenne muscular dystrophy (DMD)Associations Between Steroid Treatment and Clinical Outcomes Among Non-ambulatory Patients with Duchenne Muscular Dystrophy (DMD) (P1-1.Virtual). Craig McDonald, Oscar Mayer, Kan Hor, Jessica Marden, Jonathan Freimark, Henry Lane, Adina Zhang, Molly Frean, Claudio Santos, Richard Able, James Signorovitch. Neurology May 2022, 98 (18 Supplement) 1348

https://n.neurology.org/content/98/18_Supplement/1348
CureDuchenne
7159James SignorovitchAnalysis GroupAssociations between steroid treatment, functional outcomes and disease milestones among non-ambulatory patients with Duchenne muscular dystrophy (DMD)Associations Between Deflazacort Versus Prednisone/Prednisolone and Markers of Disease Progression in Clinically Important Subgroups of Patients with Duchenne Muscular Dystrophy (P1-1.Virtual). Craig McDonald, Jessica Marden, Henry Lane, Adina Zhang, Ha Nguyen, Claudio Santos, Richard Able, James Signorovitch. Neurology May 2022, 98 (18 Supplement) 1437

https://n.neurology.org/content/98/18_Supplement/1437
CureDuchenne
7164Jörg EllingerUniversity Hospital BonnEvaluation of CRP (c-reactive protein) flare phenomena as an early predictor of response to the Atezolizumab + Bevacizumab therapy in renal cell carcinomaSaal J, Bald T, Hölzel M, Ritter M, Brossart P, Ellinger J, Klümper N. In the phase 3 IMmotion151 trial of metastatic renal cell carcinoma the easy-to-implement modified Glasgow prognostic score predicts outcome more accurately than the IMDC score. Ann Oncol. 2022 Jun 15:S0923-7534(22)01730-6.


doi: 10.1016/j.annonc.2022.06.003
Roche
7241Frederick ReimherrPsychiatric and Behavioral Solutions, LLCRetrospective Analysis of Emotional Symptoms in Adults with ADHD and Improvement Produced by BrexpiprazoleReimherr, Frederick W.; Gift, Thomas E.; Steans, Tammy A.; Reimherr, Matthew L.; Rosenberg, Leon I.; Wilson, Melissa; Marchant, Barrie K. The Use of Brexpiprazole Combined With a Stimulant in Adults With Treatment-Resistant Attention-Deficit/Hyperactivity Disorder. Journal of Clinical Psychopharmacology: August 17, 2022 - Volume - Issue - 10.1097/JCP.0000000000001592.

doi : 10.1097/JCP.0000000000001592.
Otsuka
7245Manabu TakakiOkayama UniversityClinical moderators of response to nalmefene in alcohol dependence: Results from a randomized controlled trial in JapanNozomu Hashimoto, Hiroshi Habu, Soshi Takao, Shinji Sakamoto, Yuko Okahisa, Keitaro Matsuo, Manabu Takaki, Yoshiki Kishi, Norihito Yamada. Clinical moderators of response to nalmefene in a randomized-controlled trial for alcohol dependence: an exploratory analysis. Drug and Alcohol Dependence, 2022, 109365, ISSN 0376-8716.

doi: 10.1016/j.drugalcdep.2022.109365
Otsuka
7387Neeraj NarulaHamilton Health SciencesComparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn’s DiseaseNarula, Neeraj; Wong, Emily C.L.; Dulai, Parambir S.; Marshall, John K.; Jairath, Vipul; Reinisch, Walter. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn’s Disease. The American Journal of Gastroenterology: April 15, 2022 - Volume - Issue - 10.14309/ajg.0000000000001795.

doi: 10.14309/ajg.0000000000001795
AbbVie, Johnson & Johnson, Takeda
7388Byeongzu GhangJeju National University HospitalReanalysis of CARES study to investigate the changes of estimated glomerular filtration rate after long-term febuxostat or allopurinol treatment in gout patientsGhang B, Kim J, Yoo. BPOS0284 CHANGES OF ESTIMATED GLOMERULAR FILTRATION RATE AFTER LONG-TERM FEBUXOSTAT OR ALLOPURINOL TREATMENT IN GOUT PATIENTS. Annals of the Rheumatic Diseases 2022;81:386 .

https://ard.bmj.com/content/81/Suppl_1/386.1.full
Takeda
7388Byeongzu GhangJeju National University HospitalReanalysis of CARES study to investigate the changes of estimated glomerular filtration rate after long-term febuxostat or allopurinol treatment in gout patientsByeongzu Ghang, Jinseok Kim. Effects of long-term febuxostat or allopurinol on the progression of chronic kidney disease. Journal of Rheumatic Diseases Vol. 29, Suppl. 1, May, 2022 p271 O-54.

https://kcr2022.com/download/KCR2022_Abstract%20Book.pdf?ver=8
Takeda
7591, 7392Neeraj NarulaHamilton Health SciencesPredictors of Placebo Response and Remission in Ulcerative Colitis and Crohn’s DiseaseWong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W, Narula N. Predictors of Placebo Induction Response and Remission in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug 24:S1542-3565(22)00811-4.

doi : 10.1016/j.cgh.2022.08.015
AbbVie, Johnson & Johnson, Pfizer, Takeda
7609Joao Pedro FerreiraPorto UniversityThe impact of albiglutide on heart failure outcomes among patients with type 2 diabetes with and without heart failure at baselineFerreira JP, Sharma A, Vasques-Nóvoa F, Angélico-Gonçalves A, Leite AR, Borges-Canha M, Carvalho D, Packer M, Zannad F, Leite-Moreira A, Neves JS. Albiglutide in patients with type 2 diabetes and heart failure: a post-hoc analysis from Harmony Outcomes. Eur J Heart Fail. 2022 Aug 23.

doi: 10.1002/ejhf.2660
GSK

2021

Data Request IDLead InvestigatorInstitutionResearch Proposal TitlePublic DisclosureData Contributor(s)
3288Marc-Antoine SparfelTours HospitalMIDRA: influence of demographic and environmental factors on anti-tumor necrosis factor efficacy in rheumatoid arthritis a systematic review and meta-analysis of randomized controlled trialsLaw-Wan J, Sparfel M, Derolez S, et al. Predictors of response to TNF inhibitors in rheumatoid arthritis: an individual patient data pooled analysis of randomised controlled trials. RMD Open 2021;7:e001882.

doi: 10.1136/rmdopen-2021-001882
AbbVie, Pfizer, UCB
3320John FrewRockefeller UniversityAnalysis of Outcome Measures in Hidradenitis SuppurativaFrew, 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.

doi: 10.3389/fmed.2021.603281
AbbVie
3762Lin WangJohns 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,

doi: 10.1093/jnci/djab071
Pfizer, Project Data Sphere
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 trialsAkira 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,

doi: 10.1016/j.jjcc.2020.12.010
Boehringer Ingelheim
4043Janneke van der WoudeErasmus Medical CenterEffect of treatment on lipid profiles in patients with inflammatory bowel disease a systematic review and meta-analysisJ 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.

doi: 10.1093/ecco-jcc/jjab076.416
Pfizer
4043Janneke van der WoudeErasmus Medical CenterEffect of treatment on lipid profiles in patients with inflammatory bowel disease a systematic review and meta-analysisSleutjes, 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.

doi: 10.1111/apt.16580
Pfizer
4316Martin OkunFort HealthcareGeospatial 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

doi: 10.1016/j.jid.2021.02.290
AbbVie
4330Laure GossecSorbonne UniversitéDomains 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
Pfizer
4918Nina HilkensRadboudumc NijmegenAssociation between blood pressure, blood pressure variability and the risk of post-stroke dementiaHilkens, 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
Boehringer Ingelheim
5073Philip RobinsonUniversity of QueenslandAssessment of treatment outcome using ASAS40 with etanercept in non-radiographic axSpA by baseline CRP - a re-analysis of trial dataTam, 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.

doi: 10.1002/acr2.11312
Pfizer
5074Sebastian ZundlerUniversity Hospital ErlangenEvaluation of the relationship between vedolizumab peripheral blood serum level at week 6 and binary clinical outcomes at week 10/14 - a meta-analysisBecker E, Dedden M, Gall C, et al. Residual homing of α4β7-expressing β1+PI16+ regulatory T cells with potent suppressive activity correlates with exposure-efficacy of vedolizumab. Gut Published Online First: 30 August 2021.

doi: 10.1136/gutjnl-2021-324868
Takeda
5086Junko TakeshitaUniversity of Pennsylvania A Systematic Review to Describe the Demographic Diversity of Dermatologic Clinical Trial Participants for Common Dermatologic Diseases560 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

doi: 10.1016/j.jid.2021.02.587
AbbVie, Lilly, Regeneron
5095Mathilde NijkeuterUniversity Medical Center UtrechtAssessing 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.
Daiichi Sankyo
5096Joo Sang LeeSamsung Medical Center, South KoreaHarnessing genetic interactions to advance precision cancer medicineSynthetic lethality-mediated precision oncology via the tumor transcriptome. Lee, Joo Sang et al.
Cell, Volume 184, Issue 9, 2487 - 2502.e13.

doi: 10.1016/j.cell.2021.03.030
Tempus Labs
5163Susan BatesColumbia University Medical CenterAssessing the tumor growth and decay rates in patients with pancreatic cancer treated with Gemcitabine/Abraxane: Comparing real world data with clinical trial dataKeith 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.

doi: 10.1053/j.seminoncol.2021.02.001
Celgene Corporation
5165Byeongzu GhangJeju National University HospitalReanalysis of CARES study to investigate the incidence of cardiovascular events and death after initiation and discontinuation of allopurinol and febuxostatGhang B, Lee JS, Kim J, Yoo B. Increased risk of cardiovascular events and death in the initial phase after discontinuation of febuxostat or allopurinol: Another story of the CARES trial. J Rheum Dis 2021; 28(1):219.

Abstract
Takeda
5166Thomas MetkusJohns Hopkins University School of MedicineSevere sepsis in the cardiac intensive care unit: management strategies and outcomesDugan, 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
Lilly
5166Thomas MetkusJohns Hopkins University School of MedicineSevere sepsis in the cardiac intensive care unit: management strategies and outcomesFeldman, 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.

doi: 10.1016/j.ahjo.2021.100040
Lilly
5207Fasihul KhanUniversity of NottinghamA systematic review and individual patient data meta-analysis of physiological biomarkers in idiopathic pulmonary fibrosisKhan 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.

doi: 10.1183/13993003.01612-2021
BioLINCC, Boehringer Ingelheim, Johnson & Johnson, Roche
5207Fasihul KhanUniversity of NottinghamA systematic review and individual patient data meta-analysis of physiological biomarkers in idiopathic pulmonary fibrosisA systematic review and individual participant data meta-analysis of MMP-7 and outcomes in idiopathic pulmonary fibrosis. Fasihul Khan, Iain Stewart, Gauri Saini, Karen A Robinson, Gisli Jenkins. European Respiratory Journal Sep 2021, 58 (suppl 65) PA395;

doi: 10.1183/13993003.congress-2021.PA395
BioLINCC, Boehringer Ingelheim, Johnson & Johnson, Roche
5292Désirée van der HeijdeLeiden University Medical CenterMeasurement properties of the instruments used in the outcome assessment of axial spondyloarthritisBoel A, Navarro-Compán V, van der Heijde D. Test–retest reliability of outcome measures: data from three trials in radiographic and non-radiographic axial spondyloarthritis. RMD Open 2021;7:e001839.

doi: 10.1136/rmdopen-2021-001839
UCB
5352Elena MyasoedovaMayo ClinicIndividualized Prediction of Treatment Response to Methotrexate in Patients with Rheumatoid Arthritis: A Machine Learning ApproachDuong S, Crowson C, Atkinson E, Athreya A, Davis J, Matteson E, Weinshilboum R, Wang L, Myasoedova E. Clinical Predictors of Response to Methotrexate in Patients with Rheumatoid Arthritis: A Machine Learning Approach Using Clinical Trial Data [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10).

https://acrabstracts.org/abstract/clinical-predictors-of-response-to-methotrexate-in-patients-with-rheumatoid-arthritis-a-machine-learning-approach-using-clinical-trial-data/
Roche, UCB
5456Terina MartinezCritical Path InstituteValidation of a Model-based Clinical Trial Simulation Tool to Optimize Clinical Trial Design of Studies to Investigate Efficacy of Potential Therapies for Duchenne Muscular DystrophyModeling informative drop out in a disease progression model of Duchenne Muscular Dystrophy. Rhoda Muse, Jane Larkindale, Sarah Kim, Stephan Schmidt, Juan Francisco Morales, Sudhir Sivakumaran, Ramona Belfiore-Oshan, Varun Aggarwal, Klaus Romero, Jackson Burton and Diane Corey. Statistics and PMx e.g. MBMA, Bayesian application/method, trial design, optimal design, machine learning, data mining. ACoP12 (2021) STPM-198

www.go-acop.org/?abstract=198
CureDuchenne
5456Terina MartinezCritical Path InstituteValidation of a Model-based Clinical Trial Simulation Tool to Optimize Clinical Trial Design of Studies to Investigate Efficacy of Potential Therapies for Duchenne Muscular DystrophyRamona Belfiore-Oshan, Varun Aggarwal, Rhoda Muse, Sarah Kim, Stephan Schmidt, Juan Francisco Morales, Karthik Linganeni, Sudhir Sivakumaran, Diane Corey, Klaus Romero, Terina Martinez. Acceleration of clinical trial design in Duchenne Muscular Dystrophy building a model-based Clinical Trial Simulation Tool. The Muscular Dystrophy Association (MDA) Clinical & Scientific conference, March 13-16, 2022 (Abstract).

https://mdaconference.org/node/1556
CureDuchenne
5567Neeraj Narula Hamilton Health Sciences Impact of Ulcer Size and Extent of Inflammation On Ability To Achieve Endoscopic Healing In Crohn’s Disease: An EXTEND Post-Hoc AnalysisNarula 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
AbbVie
5567Neeraj Narula Hamilton Health Sciences Impact of Ulcer Size and Extent of Inflammation On Ability To Achieve Endoscopic Healing In Crohn’s Disease: An EXTEND Post-Hoc AnalysisSa467 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.

doi: 10.1016/S0016-5085(21)01923-5
AbbVie
5895, 6117Ashley HopkinsFlinders UniversityPredictors of exposure, therapeutic and adverse effects of atezolizumab used in the treatment of advanced cancersHopkins 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.

doi: 10.3390/cancers13051176
Roche
5895, 6117Ashley HopkinsFlinders UniversityPredictors of exposure, therapeutic and adverse effects of atezolizumab used in the treatment of advanced cancersAbuhelwa 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.

doi: 10.3390/cancers13092001
Roche
5895, 6117Ashley HopkinsFlinders UniversityPredictors of exposure, therapeutic and adverse effects of atezolizumab used in the treatment of advanced cancersConcomitant 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;

doi: 10.1158/1078-0432.CCR-20-1876
Roche
5895, 6117Ashley HopkinsFlinders UniversityPredictors of exposure, therapeutic and adverse effects of atezolizumab used in the treatment of advanced cancersHopkins, A.M., Kichenadasse, G., McKinnon, R.A. et al. Efficacy of first-line atezolizumab combination therapy in patients with non-small cell lung cancer receiving proton pump inhibitors: post hoc analysis of IMpower150. Br J Cancer (2021).

doi: 10.1038/s41416-021-01606-4
Roche
5895, 6117Ashley HopkinsFlinders UniversityPredictors of exposure, therapeutic and adverse effects of atezolizumab used in the treatment of advanced cancersHopkins, A. M., Abuhelwa, A. Y., McKinnon, R. A., Logan, J. M., Kichenadasse, G., Rowland, A., & Sorich, M. J. (2021). Smoking and immunotherapy efficacy in lung cancer by PDL1 subgroups: An individual participant data meta-analysis of atezolizumab clinical trials. European Journal of Cancer.

doi: 10.1016/j.ejca.2021.10.020
Roche
5925Min Hwan KimYonsei University College of MedicineAnalysis of neutrophil to lymphocyte ratio (NLR) in ER+ breast cancer patients to predict palbociclib clinical responseOn-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.

doi: 10.1200/JCO.2021.39.15_suppl.1066
Pfizer
5931Youssef ZeidanAmerican University of Beirut Medical CenterEvaluation of Radiotherapy in Triple Negative Breast Cancer: Analysis of the BEATRICE trialKayali, M., Abi Jaoude, J., Mohammed, M. et al. Post-mastectomy Radiation Therapy in Triple-Negative Breast Cancer Patients: Analysis of the BEATRICE Trial. Ann Surg Oncol 29, 460–466 (2022).

doi: 10.1245/s10434-021-10511-2
Roche
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 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.

doi: 10.1177/1759720X211009020
Roche
5935Jian-Guo ZhouThe Second Affiliated Hospital of Zunyi Medical UniversityLongitudinal peripheral blood markers as dynamic predictors to identify efficacy and safety of patients treated with immune checkpoint inhibitors (ICIs)Zhou J, Wong AH, Wang H, et al. 329 Early blood cell count test (BCT) for survival prediction for non-small cell lung cancer patients treated with atezolizumab: integrated analysis of 4 multicenter clinical trials. Journal for ImmunoTherapy of Cancer 2021;9:

doi: 10.1136/jitc-2021-SITC2021.329
Roche
5945Neeraj Narula Hamilton Health SciencesPredictors of Mucosal Healing in Ulcerative Colitis: A Post-hoc Analysis of VARSITYNarula, 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.

doi: 10.1093/ecco-jcc/jjab073.042
Takeda
5951Mathilde NijkeuterUniversity Medical Center UtrechtIndividualized prediction of recurrence risk reduction and risk of bleeding with extended anticoagulation in patients with venous thromboembolismde 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.
Boehringer Ingelheim, Daiichi Sankyo
5959John DennisUniversity of Exeter Medical SchoolStratification of SGLT2 inhibitor glucose lowering therapy in Type 2 diabetesJ Dennis, K Young, A Mcgovern, B Mateen, S Vollmer, M Simpson, W Henley, R Holman, N Sattar, E Pearson, A Hattersley, A Jones, B Shields. (2021). Derivation and validation of a type 2 diabetes treatment selection algorithm for SGLT2-inhibitor and DPP4-inhibitor therapies based on glucose-lowering efficacy: cohort study using trial and routine clinical data.

doi: 10.1101/2021.11.11.21265959.
Boehringer Ingelheim, Takeda
5984David BakerQueen Mary University of LondonExploring possibilities to improve the risk benefit balance through analysis of the ocrelizumab phase II extension studyDavid Baker, Amy MacDougall, Angray S Kang, Klaus Schmierer, Gavin Giovannoni, Ruth Dobson. Seroconversion following COVID-19 vaccination: Can we optimize protective response in CD20-treated individuals?. Clinical and Experimental Immunology, 2021; uxab015.

doi: 10.1093/cei/uxab015
Roche
6062Alexander MeiselUniversity Hospital of ZurichNeutrophils, Neutrophil-to-Lymphocyte Ratio (NLR) and Neutropenia as Predictors of Treatment Efficacy of Atezolizumab Monotherapy and Atezolizumab-Chemotherapy-CombinationsMeisel, A., Mark, M., Haider, A., Holer, L., Hayoz, S., Gebhard, C., Bengs, S., Hochmair, M., Cappuzzo, F., Reck, M., von Moos, R., & Stenner-Liewen, F. (2021). 1279P The prognostic value of chemotherapy-induced neutropenia (CIN) in patients with advanced non-small cell lung cancer (NSCLC) in the era of chemoimmunotherapy (CIT). Annals of Oncology, 32, S996.

doi: 10.1016/j.annonc.2021.08.1881.
Roche
6489Line UhrenholtAalborg University HospitalTapering strategies of biological and targeted synthetic disease-modifying antirheumatic drugs for patients with inflammatory arthritis: a systematic review of randomised controlled trialsLine Uhrenholt, Robin Christensen, Wilfred K H Dinesen, Caroline H Liboriussen, Stine S Andersen, Lene Dreyer, Annette Schlemmer, Ellen-Margrethe Hauge, Conni Skrubbeltrang, Peter C Taylor, Salome Kristensen. Risk of flare after tapering or withdrawal of biologic/targeted synthetic disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis or axial spondyloarthritis: a systematic review and meta-analysis. Rheumatology, 2021.

doi: 10.1093/rheumatology/keab902
AbbVie
6499, 5323, 5289Ashley HopkinsFlinders UniversityPredictors of therapeutic and adverse effects of medicines used in the treatment of breast cancerPrediction of severe neutropenia and diarrhoea in breast cancer patients treated with abemaciclib. Modi, Natansh D. et al. The Breast, Volume 58, 57 – 62.

doi: 10.1016/j.breast.2021.04.003
AstraZeneca, Boehringer Ingelheim, Lilly, Pfizer, Roche
6642Neeraj NarulaHamilton Health SciencesModified Multiplier SES-CD (MM-SES-CD) on Predicting Endoscopic Remission in Crohn’s DiseaseNeeraj Narula, Emily C L Wong, Jean-Frederic Colombel, William J Sandborn, Marc Ferrante, John K Marshall, Walter Reinisch, Parambir S Dulai, Early Reduction in MM-SES-CD Score After Initiation of Biologic Therapy is Highly Specific for 1-year Endoscopic Remission in Moderate to Severe Crohn’s Disease, Journal of Crohn's and Colitis, Volume 16, Issue 4, April 2022, Pages 616–624.

Doi:10.1093/ecco-jcc/jjab183
AbbVie, Johnson & Johnson, Takeda
6686Neeraj NarulaHamilton Health SciencesExtended Validation of an Ulcerative Colitis Vedolizumab Decision Support ToolParambir S Dulai, MD, Emily C L Wong, BS, Walter Reinisch, MD, Jean-Frederic Colombel, MD, John K Marshall, MD, MSc, Neeraj Narula, MD, Decision Support Tool Identifies Ulcerative Colitis Patients Most Likely to Achieve Remission With Vedolizumab vs Adalimumab. Inflammatory Bowel Diseases, 2021; izab310,

doi: 10.1093/ibd/izab310
Takeda

2020

Data Request IDLead InvestigatorInstitutionResearch Proposal TitlePublic DisclosureData Contributor(s)
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
AbbVie
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: 10.1016/j.jdin.2020.09.005

AbbVie
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/.
AbbVie, Pfizer
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.

doi: 10.1002/14651858.CD202001
AbbVie
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.

doi: 10.1111/ced.14264

AbbVie
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.

doi: 10.1016/j.annonc.2020.03.253
Lilly
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,

doi: 10.1093/jnci/djaa116
Lilly
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.

doi: 10.1016/j.jacc.2020.03.015
Pfizer
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).

doi: 10.1186/s12916-020-01870-w
Daiichi Sankyo
5095Mathilde NijkeuterUniversity Medical Center UtrechtAssessing bleeding risk in patients with cancer-associated thrombosisde 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.

doi: 10.1055/s-0041-1735251
Daiichi Sankyo
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
AbbVie, Pfizer, Roche, UCB
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).

doi: 10.1038/s41598-020-75673-7
Roche

2019

Data Request IDLead InvestigatorInstitutionResearch Proposal TitlePublic DisclosureData Contributor(s)
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

doi: 10.1016/j.jaad.2019.12.044
AbbVie
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)

doi: 10.1161/CIR.0000000000000742
Boehringer Ingelheim