Biostatistics Symposium: Challenges and Opportunities in the Choice of Outcome Measures in Clinical Research

April 5, 2024 | 9:00am-3:00pm
Harvard School of Public Health, Kresge G1

This year’s symposium will focus on the current challenges in choosing outcomes for clinical studies that evaluate treatments for disease and provide the necessary evidence to inform decision-making in clinical practice. Speakers from academia, the pharmaceutical industry, and the FDA will discuss the issues around creating a composite patient outcome that provides a more clinically relevant and informative evaluation and synthesis of treatment benefit, safety, and patient quality of life. The symposium is geared towards the interests of biostatisticians, epidemiologists, quantitative scientists, and clinical researchers.

Check back for the symposium agenda.

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Abstracts and Bios 

Scott Evans: Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: Opening the DOOR to Patient-Centric Clinical Research Based on Benefit: Risk

Scott Evans, PhD, MS, is a professor and founding chair of the Department of Biostatistics and Bioinformatics and the director of the Biostatistics Center at Milken Institute School of Public Health at the George Washington University. He is the director of the Statistical and Data Management Center for the Antibacterial Resistance Leadership Group (ARLG) funded by National Institute of Allergy and Infectious Diseases (NIAID)/ National Institutes of Health (NIH); principal investigator of the Coordinating Center for the Exercise and Nutrition Interventions to Improve Cancer Treatment-Related Outcomes (ENICTO) in Cancer Survivors Consortium, funded by the National Cancer Institute (NCI)/NIH, and the co-PI of the Data Coordinating Center of the Clamp OR Delay among neonates with Congenital Heart Disease (CORD-CHD) clinical trial, funded by the National Heart, Lung, and Blood Institute (NHLBI)/NIH. He is the co-chair of the Benefit-Risk Balance for Medicinal Products Working Group of the Council for International Organizations of Medical Sciences (CIOMS); editor of a mini-series on data and safety monitoring boards for NEJM Evidence; and the president-elect of the Society for Clinical Trials (SCT). He is a recipient of the Mosteller Statistician Award, the Zackin Distinguished Collaborative Statistician Award, the Founders Award from the American Statistical Association (ASA), an elected member of the International Statistical Institute (ISI), and is a fellow of the ASA, SCT, and the Infectious Disease Society of America (IDSA).

Abstract coming soon. 

Darren McGuire: Composite Outcomes in Cardiovascular Trials: Lessons Learned and Where Might We Go?

Darren McGuire, MD, is a general cardiologist in the division of cardiology at the University of Texas Southwestern Medical Center, and a clinical trialist with expertise in large-scale CV outcomes trial design and execution, and drug registration/regulation, with a focus on diabetes and cardiovascular disease. He is a distinguished teaching professor of medicine with tenure, is the Jere H. Mitchell MD Distinguished Chair in Cardiovascular Science and is the lead physician of the Parkland Health Cardiology Clinics. McGuire has participated in numerous international cardiovascular clinical outcomes trials, including T2DM, obesity, and lipid trials. He is a previous member of the FDA Cardiovascular and Renal Drugs Advisory Committee. Additionally, he is deputy editor of Circulation, senior editor of Diabetes and Vascular Disease Research, and co-editor of the textbook: “Diabetes in Cardiovascular Disease: A Companion to Braunwald’s Heart Disease.” McGuire has authored/co-authored more than 480 peer-reviewed manuscripts, reviews, editorials, and book chapters, and is recognized as a “Clarivate Highly Cited Researcher.”

Abstract coming soon. 

Fred Senatore: Composite Endpoints in Cardiovascular Clinical Trials: Challenges and Evolution

Fortunato (Fred) Senatore, MD, PhD, FACC, has been a medical officer in the division of cardiology and nephrology at the U.S. Food and Drug Administration (FDA) since 2012, and has served as team leader/lead physician since January 2020. He has published on shock, medication adherence/representative populations, benefit/risk assessment, heart failure, and clinical trial challenges during the COVID-19 pandemic. He co-edited a recently released textbook on basic and clinical research, published by Springer. Additionally, Senatore teaches a variety of courses on trial design and data analysis. Prior to his tenure at the FDA, he served in the pharmaceutical industry for 17 years and was a professor of chemical engineering at Texas Tech University, where he specialized in artificial organ technology, biocompatibility, hemodynamics, and modeling/simulation of biological processes. He received his BA in biochemistry and MS in bioengineering from Columbia University, his PhD in chemical engineering from Rutgers University, his MD degree from the Texas Tech University Health Sciences Center School of Medicine, his internal medicine training at the Mayo Clinic, and his cardiology training at Harvard Medical School/Massachusetts General Hospital.

Abstract coming soon. 

Shanthi Sethuraman: Opportunities and Challenges for Outcome Studies in Metabolic Disease Areas

Shanthi Sethuraman, PhD, has more than 25 years of experience in the pharmaceutical industry, spanning various cross-functional roles across global statistical sciences. These include regulatory, chemistry, control and manufacturing, and project management. Currently, she is senior vice president and chief analytics officer of global statistical sciences, research and development, at Eli Lilly and Company. There, she leads statisticians who are integral to driving innovation and supporting discovery research for pre-clinical; chemistry, manufacturing, and controls (CMC); clinical drug development; post- launch patient access; advanced analytics; and the statistical innovation center. Sethuraman has been active in driving leadership development internally and externally. She is an active member of the Leadership in Practice Committee and Biopharmaceutical Statistics Leadership Consortium.

Abstract coming soon. 

Rui (Sammi) Tang: Beyond Traditional Measures: Evolving Perspectives on Clinical Endpoints

Rui (Sammi) Tang, PhD, is a leading expert of biostatistics in the biotech/pharmaceutical industry. She is currently the vice president, global head of biometrics, at Servier Pharmaceuticals. Tang is also co-founder of DahShu, a 501(c)(3) non-profit organization, founded to promote research and education of its 5000 members. She is currently leading teams in the innovative design scientific working group of oncology drug development and the small population working group for rare disease statistical methodology development. Prior to joining Servier, Tang was the biostatistics therapeutic area head for multiple teams at Shire Pharmaceuticals including oncology, transplants, ophthalmology, and prematurity neonates. She has worked at several other organizations, including Vertex, Amgen, Mayo Clinical, and Merck. Her research interests are primarily in the area of adaptive clinical trial design and statistical issues in precision medicine. She has authored more than 50 articles in peer-reviewed scientific journals on methodology, study design, data analysis and reporting and is a co-inventor of several patents. Tang is also an active member in ASA (American Statistics Association) and ICSA (International Chinese Statistics Association).

Abstract coming soon. 

Lee-Jen (LJ) Wei: How to Combine Patient's Multiple Outcomes to Determine the Endpoint in Clinical Studies

Lee-Jen (LJ) Wei, PhD, is a professor of biostatistics at Harvard University. His research focus is on clinical trial methodology, specializing in design, monitoring, and analysis of studies. His recent research is concentrated on translational statistics and the personalization of medicine under the risk-benefit paradigm via biomarkers and the revitalizing of clinical trial methodology. He has extensive working experience in regulatory science for developing and evaluating new drugs/devices. Wei has developed numerous novel statistical methods which are often utilized in practice. He received the prestigious Wald Medal in 2009 from the American Statistical Association for his contribution to clinical trial methodology. He is a fellow of American Statistical Associating and Institute of Mathematical Statistics. In 2014, to honor his mentorship, Harvard T.H. Chan School of Public Health established a Wei-Family scholarship to support students who are studying biostatistics. He has more than 260 publications and served on numerous editorial and scientific advisory boards including data monitoring for governments and industry.

Abstract coming soon.