Clinical Trials 2025: Enhancing Clarity and Precision to Successfully Meet Study Objectives
The gaps left by traditional ways of thinking about statistical analyses require that we adopt and integrate more effective strategies into trial designs. Defining specific treatment effects to account for complex events like rescue medication or treatment discontinuation many times leads to errors, missteps in interpretation or execution, and inconsistencies in reporting standards for trial sponsors.
Join our 60-minute panel discussion as our expert panel of medical directors, biostatisticians, and medical strategy experts address the above challenges, sharing their views on new strategies that help enhance clarity in clinical trial processes.
In this session we will discuss the role of estimands in enhancing precision to successfully meet study objectives, share examples of their application in specific trials, and analyze case studies where their misspecification has been problematic from the regulatory point of view.
Learning Objectives:
- Discussing ways to improve clarity and precision in clinical trial outcomes.
- Understanding the historical evolution of clinical trial methodologies in relation to new evolving methodologies.
- Addressing the statistical and clinical challenges of traditional trial methods.
- Investigating the role of estimands in clinical trials and how they help enhance clarity and precision.
- Analyzing case studies to identify challenges, regulatory concerns, and best practices for effective estimand application.
Speakers:
Niti Goel, Fractional Chief Medical Officer and President, Caduceus Biomedical Consulting
Niti Goel, MD, FACR is a physician-scientist who brings to light the clinical and market potential of new molecules and products, focused on getting them approved, prescribed, and in the hands of the people who need them. She has over 25 years of academic, clinical development, and medical affairs experience. Dr. Goel is currently a fractional Chief Medical Officer (CMO) and President of Caduceus Biomedical Consulting. She has held senior leadership roles at Trial Spark (now Formation Bio; Senior Vice President [VP]), Abcuro (CMO), Kezar Life Sciences (CMO), and IQVIA (VP), as well as various roles at Array BioPharma, Inc., UCB Pharma, and Procter & Gamble Pharmaceuticals and as rheumatology faculty at University of Texas Medical Branch. She currently is at Duke University School of Medicine as an Adjunct Assistant Professor and precepts trainees in the rheumatology clinic at the Durham Veterans Administration Hospital. Niti has an interest in novel trial design; diversity, equity, and inclusion in clinical trials; and the inclusion of the patient perspective in clinical research endeavors. She graduated with her B.S. degree with honors from Pennsylvania State University and summa cum laude with her M.D. degree from Jefferson Medical College of Thomas Jefferson University. She completed her internal medicine and rheumatology training at Duke University Medical Center.
Natasa Rajicic, Biostatistics/Strategy Expert
Natasa Rajicic has been a practicing biostatistician for over 20 years. As a consultant, she helps clients explore and apply appropriate study designs and address difficult clinical development problems. Her experiences range from early oncology studies employing recent methods of dose-escalation to late-stage product development issues. She has provided statistical expertise and input on adaptive study designs and implementation, including as aDSMB statistician member/chair or as an independent reviewer. Natasa also represented clients in regulatory interactions and Advisory Committee meetings. Earlier in her career, Natasa was a biostatistician at Arrowhead Pharmaceuticals, Cytel, Pfizer, Massachusetts General Hospital, and The Center for Biostatistics in AIDS Research in Boston, and she taught Research Design inthe Applied Analytics graduate programat Columbia University in New York.
Kalyan Ghosh, Founder and CEO, Inference Inc
Moderator.
