Session (CTI)

PURPOSE: Evaluations of multiple clinical-study data quantity and quality routinely are used to assess weight of evidence. The maturation of health-preference research is indicated by the number of published studies that have accumulated in some therapeutic areas. It is possible to begin thinking of preference data in terms of evidence bases, similar to clinical data. However, combining data from multiple preference studies poses several challenges, including differences in definitions of common attributes, inclusion criteria, sample sizes, and analytical techniques. This workshop will focus on how to access both published and primary study data and how to use meta-analytical and data-fusion methods to obtain consensus values for benefit-risk tradeoff preferences. Participants will learn how to assess the robustness of preference evidence bases to support regulatory, product-development, and clinical decision-making. DESCRIPTION: Workshop attendees will obtain a working knowledge of available methods for combining and applying data from multiple preference studies. The workshop will review a) how evidence bases are used for clinical data, b) how familiar methods can be adapted for preference applications, and c) how an evidence base was developed for a recent health application. Dr. Janssen will chair the session and introduce the topic in the context of clinical evidence-base construction and applications (10 min.), Dr. Ozdemir will discuss methods for harmonizing differences in study designs for different uses (15 min.), and Dr. Gonzalez Sepulveda will illustrate how these methods were applied to combine primary inflammatory-bowel-disease preference data in a fusion model to estimate consensus maximum acceptable risk. (15 min.). Audience participation will include identifying problems and solutions for a case study in diabetes (20 min). This interactive and informative workshop will help patient-centered researchers make patient-preference evidence available for a wider range of decision-making applications.