Navigating Budget Constraints: A Quantitative Framework for Effective & Patient-Centric Trial Design in Capital Key Takeaways

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.

Register for this webinar today to gain insights into a study design and authoring solution that can help in ensuring an effective and patient-centric trial design.

Speakers

Todd Georgieff, Digital Protocol Consultant

Todd Georgieff has been working in drug development for more than 30 years. He has extensive experience in global clinical operations and has also held leadership roles in many large process improvement, technology and organizational change initiatives. In the past few years, Todd has been working on projects relating to the digitization of clinical research, both at Roche and Genentech and in several cross-industry collaborations. These include TransCelerate’s Digital Data Flow initiative, leading the Precision Cancer Consortium Clinical Trial Patient Matching workstream, participating in the Decentralized Trials Research Alliance and several others. Many of these initiatives aim to make drug development more efficient and sustainable and to help our industry “break the document paradigm”.

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Scott Chetham, Co-Founder & CEO, Faro Health Inc.

Scott Chetham, PhD, is an experienced healthcare entrepreneur who is currently the CEO and Co-Founder of Faro Health. Scott leads the strategy for the Faro Health platform, which is designed to power clinical development by connecting data to decision-making in a fundamentally new way. Previously, he was the Head of Clinical Research Operations and Data Management at Verily Life Sciences, formerly known as Google Life Sciences. This multi-faceted strategic and operational role involved leading the clinical strategy, clinical teams, process development and operations for all clinical projects of the company, including Google and Google[x]. Scott has also served as a Venture Partner at Versant Ventures, CTO and Co-Founder of Intersection Medical (sold to ImpediMed) and VP of Clinical Affairs (ImpediMed). In these latter two roles, he was responsible for clinical research strategy and operations.

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Angie Maurer, Vice President of Product, Faro Health Inc.

Angie Maurer has over 20+ years of clinical research experience in the pharmaceutical, biotechnology, medical device and diagnostic industries worldwide. Prior to Faro Health, Angie worked with various companies from small start-ups to large companies providing expertise in Quality Risk Management (program and software development), GCP compliance, learning management, process development and improvement, management and oversight of drug/device development programs, clinical trial management and QA clinical audits. Angie is a highly regarded professional with progressive, successful experience in providing clinical quality and compliance solutions with a proven record of developing successful strategies and companies in the healthcare industry.

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