Tyson has 20 years of experience as a biostatistician working in clinical research. He is an expert in the design, conduct and analysis of randomized and observational studies of medical devices. In his 10 years with NAMSA, he has guided both large and small companies through the development and execution of clinical evidence plans to meet business, regulatory and reimbursement needs. He has supported research on medical devices in a wide variety of therapeutic and diagnostic areas, including heart failure, atrial fibrillation, minimally invasive treatments for benign prostate hyperplasia (BPH), traumatic brain injury (TBI), endovascular grafts for thoracic and abdominal aortic aneurysms and peripheral vascular devices for atherosclerosis. His statistical expertise focuses on trial design, strategy for interim analyses, adaptive sample size re-estimation and application of Bayesian statistics to clinical trials.

Prior to coming to NAMSA, Tyson was a biostatistician at Medtronic and the University of Minnesota. He received his Master’s Degree in Biostatistics from the University of California, Los Angeles (UCLA). He also draws on his undergraduate training as a biomedical engineer (BSE Arizona State University) to enhance collaboration with physicians and Sponsor personnel, ensuring that clinical trial design is informed by an understanding of the physiological mode of action of the medical devices being evaluated.

CORE COMPETENCIES 

• Advising on strategy for statistical design and analysis of clinical research studies
• Negotiating with the U.S. Food and Drug Administration (FDA) and other regulatory agencies regarding study design and statistical analyses, including those for the Breakthrough Devices Program
• Serving as a statistical member on Data Safety and Monitoring Boards (DSMBs) for a variety of medical devices
• Reviewing statistical analysis plans to ensure sound design and adherence to best practices
• Analyzing and reporting data from large, multi-center pivotal clinical trials, as well as small feasibility and pilot studies
• Working with DSMBs to establish charters and prepare monitoring and interim analysis reports
• Serving as an independent statistician for interim analyses, adaptive design calculations, or two-stage outcome-free propensity score designs
• Creating tables and graphs and providing statistical expertise for scientific conference presentations and journal publications, including co-authorship in the New England Journal of Medicine (NEJM) and Lancet
• Preparing written responses to the FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) regarding statistical design and analyses
• Calculating sample sizes and creating randomization schedules

RECENT PROJECTS 

• Led analysis of a completed pivotal trial resulting in a late-breaking clinical trial presentation at the annual Heart Rhythm Society meeting, manuscript publication and application for premarket approval to FDA
• Created a single-arm non-randomized study design synopsis for an FDA Q-submission (pre-submission), including a well-justified performance goal using synthesis of available publications
• Compared study designs using adaptive sample size re-estimation versus fixed sample size group sequential methods to help a Client understand key differences and pros/cons of how each approach uses information available at an interim analysis
• Developed a Bayesian predictive probability analysis to provide regulatory reviewers with an assessment, based on the available data at the time of submission, of the likelihood that long-term outcomes will be favorable at the conclusion of study follow-up

PUBLICATIONS

• Parikh SA, Schneider PA, Mullin CM, Rogers T, Gray WA. Mortality in randomised controlled trials using paclitaxel-coated devices for femoropopliteal interventional procedures: an updated patient-level meta-analysis. Lancet. 2023 Nov 18;402(10415):1848-1856. doi: 10.1016/S0140-6736(23)02189-X. Epub 2023 Oct 24. PMID: 37890499.
• Kirschen MP, Myers SR, Neuman MI, Grubenhoff JA, Mannix R, Stence N, Yang E, Woodford AL, Rogers T, Nordell A, Vossough A, Zonfrillo MR. Intracranial Traumatic Hematoma Detection in Children Using a Portable Near-infrared Spectroscopy Device. West J Emerg Med. 2021 Mar 24;22(3):782-791. doi: 10.5811/westjem.2020.11.47251. PMID: 34125061; PMCID: PMC8203002.
• Zile MR, Lindenfeld J, Weaver FA, Zannad F, Galle E, Rogers T, Abraham WT. Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2020 Jul 7;76(1):1-13. doi: 10.1016/j.jacc.2020.05.015. PMID: 32616150.
• McVary KT, Rogers T, Roehrborn CG. Rezūm Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. 2019 Apr;126:171-179. doi: 10.1016/j.urology.2018.12.041. Epub 2019 Jan 21. PMID: 30677455.
• Gupta N, Rogers T, Holland B, Helo S, Dynda D, McVary KT. Three-Year Treatment Outcomes of Water Vapor Thermal Therapy Compared to Doxazosin, Finasteride and Combination Drug Therapy in Men with Benign Prostatic Hyperplasia: Cohort Data from the MTOPS Trial. J Urol. 2018 Aug;200(2):405-413. doi: 10.1016/j.juro.2018.02.3088. Epub 2018 Mar 1. PMID: 29499208.
• Auricchio A, Hudnall JH, Schloss EJ, Sterns LD, Kurita T, Meijer A, Fagan DH, Rogers T. Inappropriate shocks in single-chamber and subcutaneous implantable cardioverter-defibrillators: a systematic review and meta-analysis. Europace. 2017 Dec 1;19(12):1973-1980. doi: 10.1093/europace/euw415. PMID: 28340005; PMCID: PMC5834016.
• Kramer DB, Jones PW, Rogers T, Mitchell SL, Reynolds MR. Patterns of physical activity and survival following cardiac resynchronization therapy implantation: the ALTITUDE activity study. Europace. 2017 Nov 1;19(11):1841-1847. doi: 10.1093/europace/euw267. PMID: 27702867; PMCID: PMC5834044.
• Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600. PMID: 24963567.
• Martin DO, Lemke B, Birnie D, Krum H, Lee KL, Aonuma K, Gasparini M, Starling RC, Milasinovic G, Rogers T, Sambelashvili A, Gorcsan J 3rd, Houmsse M; Adaptive CRT Study Investigators. Investigation of a novel algorithm for synchronized left-ventricular pacing and ambulatory optimization of cardiac resynchronization therapy: results of the adaptive CRT trial. Heart Rhythm. 2012 Nov;9(11):1807-14. doi: 10.1016/j.hrthm.2012.07.009. Epub 2012 Jul 14. PMID: 22796472.
• Krum H, Lemke B, Birnie D, Lee KL, Aonuma K, Starling RC, Gasparini M, Gorcsan J, Rogers T, Sambelashvili A, Kalmes A, Martin D. A novel algorithm for individualized cardiac resynchronization therapy: rationale and design of the adaptive cardiac resynchronization therapy trial. Am Heart J. 2012 May;163(5):747-752.e1. doi: 10.1016/j.ahj.2012.02.007. PMID: 22607850.