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Helping our clients find solutions to their challenges is our top priority. This library of case studies, journal articles and other publications are an excellent resource for your team.

Recent Publications

Key Publications
2020
2019
2018
2017
2016
2015
2014
2013
2012
PSE RELEVANT PUBLICATIONS
  • Zariffa, N., Haggstrom, J. & Rockhold, F. Open Science to Address COVID-19: Sharing Data to Make Our Research Investment Go Further. Ther Innov Regul Sci (2020). https://doi.org/10.1007/s43441-020-00250-z
  • Harari O, Hsu G, Dron L, Park JJH, Mills EJ, Thorlund K. Utilizing Bayesian Predictive Power in Clinical Trial Design. Pharmaceutical Statistics. 2020; 1– 16. https://doi.org/10.1002/pst.2073
  • Forrest JI, Rayner CR, Park JJH, Mills EJ. Early Treatment of COVID-19 Disease: A Missed Opportunity. Infectious Diseases and Therapy. 2020; DOI: 10.1007/s40121-020-00349-8
  • Dillman A, Park JJH, Zannat NE, Lee Z, Dron L, Hsu G, Smith G, Khakabimamaghani S, Harari O, Thorlund K, Mills EJ. Reporting and Design of Randomized Clinical Trials for COVID-19: A Systematic Review. Contemporary Clinical Trials. 2021;101:106239.
  • Dillman A, Zorratti M, Park JJH, Hsu G, Dron L, Smith G, Harari O, Rayner CR, Zannat NE, Gupta A, Mackay E, Arora P, Lee Z, Mills EJ. The landscape of emerging randomized clinical trial evidence for COVID-19 disease stages: A systematic review of global trial registries. Infection and Drug Resistance. 2020. Accepted
  • Accelerating Clinical Evaluation of Repurposed Combination Therapies for COVID-19 Craig R. Rayner, Louis Dron, Jay J. H. Park, Eric H. Decloedt, Mark F. Cotton, Vis Niranjan, Patrick F. Smith, Michael G. Dodds, Fran Brown, Gilmar Reis, David Wesche, Edward J. Mills
  • Lancet Global Health 4 series on “Series in Clinical Trials in Global Health” – Forthcoming: 
Park JJH, Grais R, Taljard M, Nakimuli-Mpungu E, Jehan F, Nachega J, Ford N, Xavier D, Kengne A, Ashorn P, Socias ME, Bhutta ZA, Mills EJ. Global health clinical trials: Urgently seeking efficiency and sustainability. Lancet Global Health, 2020. Accepted
 
Park JJH, Ford N, Xavier D, Ashorn P, Grais R, Bhutta ZA, Goossens H, Thorlund T, Socias ME, Mills EJ. Global health clinical trials: Randomised trials at the level of individual. Lancet Global Health, 2020. Accepted

 

Dron L, Taljard M, Cheung YB, Grais R, Ford N, Thorlund K, Jahan F, Nakimuli-Mpungu E, Xavier D, Bhutta ZA, Park JJH, Mills EJ. Global health clinical trials: Role and challenges of cluster randomized trials for global health. Lancet Global Health, 2020. Accepted
 
Park JJH, Mogg R, Smith GE, Nakimuli-Mpungu E, Jehan F, Rayner CR, Condo J, Decloedt EH, Nachega J, Reis G, Mills EJ. How COVID-19 fundamentally changed clinical research in global health. Lancet Global Health, 2020. Accepted

  • Chen, Xianwen MD; Ren, Cuiping MD; Li, Juan MD; Wang, Shangpei MD; Dron, Louis MSc; Harari, Ofir PhD; Whittington, Craig PhD The Efficacy and Safety of Piribedil Relative to Pramipexole for the Treatment of Early Parkinson Disease: A Systematic Literature Review and Network Meta-Analysis, Clinical Neuropharmacology: 7/8 2020 - Volume 43 - Issue 4 - p 100-106 doi: 10.1097/WNF.0000000000000400
  • Ghosh P, Liu L, Mehta CR. Adaptive Multiarm Multistage Clinical Trials. Statistics in Medicine, 2020; 39:1084-1102.
  • Ferreira JP, Mehta CR, Sharma A, Nissen SE, Rossignol P, Zannad F. Alogliptin after acute coronary syndrome in patients with type 2 diabetes: a renal function stratified analysis of the EXAMINE trial. BMC Medicine, 2020; 18:165.
  • Elharram M, Sharma A, White W, Bakris G, Rossignol P, Mehta CR, Ferreira JP, Zannad, F. Timing of Randomization after an Acute Coronary Syndrome in Patients with Type-2 Diabetes Mellitus. American Heart Journal, 2020 (in Press).
  • Ferreira JP, Rossignol P, Sharma, A, White WB, Mehta CR, Bakris G, Zannad, F. Multi-proteomic approach to predict specific cardiovascular events in patients with diabetes and myocardial infarction: findings from the EXAMINE trial. Clinical Research in Cardiology, 2020. Published on-line, DOI 10.1007/s00392-020-01729-3.
  • Ankolekar S., Mehta C., Mukherjee R., Hsiao S., Smith J., Haddad T. (2020) Monte Carlo Simulation for Trial Design Tool. In: Piantadosi S., Meinert C. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_251-1

 

  • Park, Jay JH, et al. "Association of early interventions with birth outcomes and child linear growth in low-income and middle-Income countries: Bayesian network meta-analyses of randomized clinical trials." JAMA network open 2.7 (2019): e197871-e197871.
  • Mehta, C. R., L. Liu, and C. Theuer. "An adaptive population enrichment phase III trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (TAPPAS trial)." Annals of Oncology 30.1 (2019): 103-108.
  • Hsiao, Samuel T., Lingyun Liu, and Cyrus R. Mehta. "Optimal promising zone designs." Biometrical Journal 61.5 (2019): 1175-1186.
  • Mehta, C. R., et al. “Exact Inference for Adaptive Group Sequential design,” in Liu, Ray, and Yi Tsong, eds. Pharmaceutical Statistics: MBSW 39, Muncie, Indiana, USA, May 16-18, 2016. Vol. 218. Springer, 2019.
  • Park JJH, Siden E, Zoratti MJ, et al. Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols. BMC Trials 2019; 20(1): 572.
  • Siden EG, Park JJ, Zoratti MJ, et al. Reporting of master protocols towards a standardized approach: A systematic review. Contemporary Clinical Trials Communications 2019; 15: 100406.
  • Park JJ, Harari O, Dron L, Mills EJ, Thorlund K. Effects of biomarker diagnostic accuracy on biomarker-guided phase 2 trials. Contemporary Clinical Trials Communications 2019; 15: 100396.
  • Mills EJ, Nsanzimana S. Have clinical trials in HIV finally matured? Lancet HIV 2019; 6 (9): 561-563.
  • Zhang K, Arora P, Sati N, Béliveau A, Troke N, Veroniki AA, Rodrigues M, Rios P, Zarin W, Tricco AC. Characteristics and methods of incorporating randomized and nonrandomized evidence in network meta-analyses: a scoping review. Journal of Clinical Epidemiology 2019; 113:1-10.
  • Welch VA, Hossain A, Ghogomu E, Riddle A, Cousens S, Gaffey M, Arora P, Black R, Bundy D, Castro MC, Chen L. Deworming children for soil-transmitted helminths in low and middle-income countries: systematic review and individual participant data network meta-analysis. Journal of Development Effectiveness. 2019 Dec 7:1-9.
  • Dron L, Golchi S, Hsu G, Thorlund K. Minimizing control group allocation in randomized trials using dynamic borrowing of external control data - An application to second line therapy for non-small cell lung cancer. Contemporary Clinical Trials Communications 2019; 16: 100446.
  • Gupta, A., Slater, J. J., Boyne, D., Mitsakakis, N., Béliveau, A., Druzdzel, M. J., … Arora, P. (2019). Probabilistic Graphical Modeling for Estimating Risk of Coronary Artery Disease: Applications of a Flexible Machine-Learning Method. Medical Decision Making 2019; 39(8):1032-1044. 
  • Arora P, Boyne D, Slater JJ, Gupta A, Brenner DR, Druzdzel MJ. Bayesian Networks for Risk Prediction Using Real-World Data: A Tool for Precision Medicine. Value Health 2019; 22(4):439-445.
  • Jafar R, Labrosse M, Weaver JD, Retta SM, Wu C, Duraiswamy N. A Computational Study on Deformed Bioprosthetic Valve Geometries: Clinically Relevant Valve Performance Metrics. J Biomech Eng 2019.
  • Khakabimamaghani S, Kelkar YD, Grande BM, Morin RD, Ester M, Ziemek D. SUBSTRA: Supervised Bayesian Patient Stratification. Bioinformatics 2019; 35(18):3263-3272.
  • Gupta A, Arora P, Brenner D, Edmonson-Jones M, Parkhomenko E, Stevens W, Wagner S, Borrill J, Wu E. Application of a Machine Learning Model to Predict Survival Outcomes for Patients with Advanced Renal Cell Carcinoma (aRCC) Treated with Nivolumab. In41st Annual Meeting of the Society for Medical Decision Making 2019 Oct 23. 
  • Zhang K, Arora P, Sati N, Béliveau A, Troke N, Veroniki AA, Rodrigues M, Rios P, Zarin W, Tricco AC. Characteristics and methods of incorporating randomized and nonrandomized evidence in network meta-analyses: a scoping review. Journal of Clinical Epidemiology 2019; 113:1-10.
  • Arora P, Thorlund K, Brenner DR, Andrews JR. Comparative accuracy of typhoid diagnostic tools: A Bayesian latent-class network analysis. PLoS Neglected Tropical Diseases 2019; 8;13(5):e0007303.
  • Park JJH, Fang ML, Harari O, et al. Association of Early Interventions With Birth Outcomes and Child Linear Growth in Low-Income and Middle-Income Countries: Bayesian Network Meta-analyses of Randomized Clinical Trials. JAMA Netw Open 2019; 2(7): e197871.
  • Gupta A, Brenner DR, Arora P. PMU12 Scalable Decision-Analytic Modelling with Influence Diagrams. Value in Health. 2019 May 1;22:S251.
 
  • An adaptive population enrichment phase III trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (TAPPAS trial)
    Annals of Oncology
    C R Mehta, L Liu, C Theuer
  • ADaM Intermediate Dataset: how to improve your analysis traceability
    PhUSE US Connect 2018, Paper SD16
    Tinazzi, A. Curto, T. and Aggarwal, A.
  • Confidence, credibility and prediction.
    METRON, 76(2), pp.251-268
    Aitkin, M. and Liu, C.
  • Liu L, Hsiao S, Mehta CR. Efficiency Considerations for Group Sequential Designs with Adaptive Unblinded Sample Size Re-assessment. Statistics in Biosciences, 2018; 10(2):405-419.
  • Hwang Y-C, Morrow DA, ..., Mehta CR, ..., White WB. High-sensitivity C-reactive protein, low-density lipoprotein cholesterol and cardiovascular outcomes in patients with type 2 diabetes in the EXAMNE trial. Diabetes, Obesity and Metabolism, 2018; 20(3):654-659.
  • Cavender M, White WB, ..., Cannon CP. Total Cardiovascular Events Analysis of the EXAMINE Trial in Patients with Type 2 Diabetes and Recent Acute Coronary Syndrome. Clinical Cardiology, 2018; vol 41, pages 1022-1027.
  • Green SJ, Mentz RJ, ..., Mehta CR, ...O'Connor CM. Reassessing the Role of Surrogate Endpoints in Drug Development for Heart Failure. Circulation, 2018; 138(10):1039-1053.
  • White WB, Jalil F, ..., Mehta CR, Zannad F. Average Clinician-Measured Blood Pressures and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Ischemic Heart Disease in the EXAMINE Trial. Journal of the American Heart Association, 2018; 7(20), e009114.
  • Menon V, Nichols SJ, ..., Mehta CR, ... Nissen SE. Fasiglifam-induced liver injury in patients with type-2 diabetes: results of a randomized controlled cardiovascular oucomes safety trial. Diabetes Care, 2018; 41:2608-2609.
  • Multiplicity: discussion points from the Statisticians in the Pharmaceutical Industry multiplicity expert group.
    Pharmaceut. Statist., 2013, 12 255–259
    Phillips, A., Fletcher, C., Atkinson, G., Channon, E., Douiri, A., Jaki, T., Maca, J., Morgan, D., Roger, JH. and Terrill, P.
  • PEARL I Study Group. Ulipristal acetate versus placebo for fibroid treatment before surgery.
    N Engl J Med., 2012; 366(5):409-20.
    Donnez J, Tatarchuk TF, Bouchard P, Puscasiu L, Zakharenko NF, Ivanova T, Ugocsai G, Mara M, Jilla MP, Bestel E, Terrill, P., Osterloh I and Loumaye E.
  • PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids.
    N Engl J Med., 2012; 366(5):421-32.
    Donnez J, Tomaszewski J, Vázquez F, Bouchard P, Lemieszczuk B, Baró F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill, P., Osterloh I and Loumaye E.

COST-EFFECTIVENESS ANALYSES

COST-CONSEQUENCE MODELS

BUDGET IMPACT MODELS

4 ITC/NMA/STC/MAIC

QOL/UTILITY

RWE

SYSTEMATIC LITERATURE REVIEW AND BURDEN OF ILLNESS

EARLY ECONOMIC MODELS AND VALUE FRAMEWORKS

HEALTH ECONOMICS METHODS

ENDPOINT VALIDATION

HEALTH TECHNOLOGY ASSESSMENTS