Platform Trials: A Biostatistics Perspective

Learn how innovative study designs and proactive communication can enhance efficiency and cost-effectiveness in your trials.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/biostatistics

Event overview

In recent years, the prevalence of platform clinical trials has increased. These are randomized, adaptive trials designed to evaluate multiple therapies for the same indication, governed by one overarching master protocol. Treatment arms are continually added and discontinued according to preestablished rules. Each arm is compared to a shared control group.

Platform trials present a unique opportunity to accelerate assessment of drug candidates, to optimize patient enrollment, and to build an evidence base allowing evaluation of the holistic state of treatment options for an indication. They also offer improved efficiency and cost-effectiveness by assessing multiple therapies under one shared clinical trial infrastructure.

The biostatistics team is uniquely positioned to provide input on study data integrity throughout the life cycle of the trial. Effective and proactive communication is key to a biostatistics study management strategy that allows the team to navigate the needs of numerous stakeholders. Establishing a forward-thinking statistical analysis framework creates opportunities to capture efficiencies in the analysis of multiple arms. The complex infrastructure demanded by these adaptive trials requires a philosophy of continuous improvement to leverage lessons learned in the ever-changing landscape of your platform trial.

Key take-aways

• Innovative study design: shared platform infrastructure improves efficiency and cost-effectiveness
  
• Begin with the end in mind: establish a forward-thinking statistical analysis framework to capture efficiencies
  
• Communication is key: proactive and effective communication to manage multiple stakeholders
  
• Continuous improvement: leveraging lessons learned as the platform evolves
  
• Ultimate collaboration: accelerate availability of the most effective treatments for patients

Speakers:

Elise Covert, MS
Biostatistician II
IQVIA

Elise Covert, MS, has been a biostatistician with IQVIA since 2022. Her experience includes over two years as a statistical team lead responsible for planning and delivering statistical analyses for clinical trials in oncology, dermatology, and cardiology. Since April 2023, Covert has led the biostatistics team for a platform trial in oncology comprising six experimental treatment arms. Covert completed her undergraduate degree in applied mathematics at Bucknell University and her MS in biostatistics at the University of Michigan School of Public Health. She is based in Austin, Texas.

Kayla Williamson
Senior Biostatistician
IQVIA

Kayla Williamson is an experienced biostatistician with 7 years of statistical consulting experience in academic and CRO settings. She began working at IQVIA in January 2022, where her primary responsibilities include leading, planning, and delivering statistical analyses for studies pertaining to pediatric gastrointestinal disorders, oncology, and the adult central nervous system. Kayla completed her undergraduate degree in Statistics at the University of Wyoming and her M.S. in Biostatistics at the University of Colorado Denver. She is home-based in South Carolina.

Carol Udell
Senior Director, Biostatistics
IQVIA

Carol Udell has been a leader of the IQVIA Biostatistics department for more than 15 years, and in the industry for more than 30 years. Her prior experience includes positions in biostatistics, data management, and business development in both large pharma and CRO environments. Carol completed her undergraduate degree in Mathematics and Computer Science at Mansfield University and her M.S. in Biostatistics at the University of North Carolina School of Public Health. She is home-based in New Jersey.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/biostatistics