Beyond P-Values and Sample Size Calculations: Probability of Success for Indirect Comparative Efficacy Forecasting and Its Role in Industry Decision Making
Moderator
Claire L Simons, OPEN Health, Rotterdam, Netherlands
Speakers
Elizabeth Sigworth, PhD, OPEN Health Group, Rotterdam, Netherlands; Michael Hurst, BSc, MSc, Bristol Myers Squibb, Uxbridge, United Kingdom
Purpose
Probability of success (PoS) is frequently used in clinical trials as a metric to assess predictions of eventual trial success through defining significance thresholds of hazard ratio or effect estimates between trial arms. It enables a better understanding of risk-benefit within clinical trial strategy and is useful specifically in resource optimisation.
Alongside clinical trials, PoS has the potential to be a useful tool when assessing indirect treatment comparison (ITC) outputs. This approach can aid in forecasting comparative efficacy alongside therapeutic product profiles and support strategy planning and decision making.
Participants will be introduced to practical frameworks for generating estimates of anticipated effects (and uncertainty) for comparators within the network for various definitions of success. This educational workshop will be valuable to researchers, health economists, and industry analysts who are interested in new and innovative ways to inform prioritisation and decision-making.
Description
Workshop attendees will obtain a working knowledge of the application and benefits of PoS analyses in an ITC context. The workshop will cover A) introduction to PoS in its original context, B) extension of PoS to ITC and comparative efficacy forecasting, C) results of an example case study including a live interactive simulation, and D) discussion of the utility of the approach for industry.
CS will moderate the session and introduce PoS as it is currently applied in clinical trials (10 min). ES will show how this method can be extended to comparative efficacy forecasting, through a case study demonstration via Shiny app (20 min). MH will discuss the role of PoS in industry decision making, including insight into its value in cross-disciplinary stakeholder discussions (15 min). Audience participation will include polling for expected outcomes during the live simulation portion, as well as elicitation of inputs to test in the Shiny app and Q+A (15 min).
Code
121
Topic
Clinical Outcomes, Health Technology Assessment, Methodological & Statistical Research