Featuring: Steven R. Cummings, MD, Emeritus Professor of Medicine, Epidemiology, and Biostatistics, University of California, San Francisco and Scott Chetham, PhD, CEO, Faro Health Inc.
Abstract: Sponsors and study teams must navigate considerable uncertainty to ensure safety and efficacy endpoints meet the approval of health authorities, regulatory agencies and payers. They must achieve this while also ensuring studies are patient-centric and that key risks are mitigated while collecting complete data to support approval.Regulatory guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other authorities urge sponsors to focus their efforts on efficacy and safety objectives and minimize the collection of data that do not contribute to data assessment but may add to trial cost, burden and risk. But, it is unclear how to leverage operational strategies, adaptive or innovative study designs or other tactics for this purpose.
This webinar will provide a clear framework and methodology to optimize the design of clinical trials to achieve key outcomes in resource-constrained environments. The expert speakers will demonstrate how a study design and authoring solution can be invaluable. By sharing clear examples, they will illustrate ways to ensure that critical study aspects are not only accounted for, but balanced against patient burden, site burden and cost.They will also show how the Faro Health solution can help study teams navigate these competing considerations with the benefit of metrics and analytics presented in real time to make informed study design decisions. Furthermore, they will show how the use of a digital protocol design and authoring tool allows users to understand the criticality of study design variables and weigh those against cost and complexity to support decisions as development programs are implemented.
What You Will Learn:
- Strategic budget allocation: Learn strategies for optimizing the allocation of limited resources to maximize the impact of the clinical trial
- Risk mitigation: Explore techniques to identify and mitigate risks associated with financial constraints, thus enhancing the feasibility and success of the trial
- Adaptability in trial design: Gain insights into crafting trials that can adapt to financial challenges while maintaining scientific rigor