PPT-Predicting subgroup treatment effects for a new study: Organization, results and learnings

Björn Bornkamp PSI Conference 2022 Göteborg June 13 2022 Global Drug Development Analytics AMDS Organizing team amp coauthors C arsten Müller Conor Moloney Giulia Capestro Jana Starkova. Internal Assessment. Criterion A: . Introduction, 5 marks, 3.6% of IB Grade . Criterion B: . Method: Design, 2 marks, 1.4% of IB Grade . Criterion C: . Method: Participants, 2 marks, 1.4% of IB Grade . What Can Go Wrong?. Skeptic’s Toolbox. 2012. Harriet Hall, MD. The . SkepDoc. Overview. What constitutes evidence in medicine?. What can go wrong in clinical studies?. Why even “evidence-based medicine” is flawed.. Christopher . Jennison. , University of Bath. Robert A. Beckman, Daiichi Sankyo Pharmaceutical Development and University of California at San Francisco. Agenda. TOPIC 1: Where do subgroups come from? Empirical data or basic science? How does this vary as a function of developmental stage? . . Christopher . H . Schmid. Brown University. Christopher_schmid@brown.edu. Rutgers. University. 16 . May 2013. New Brunswick, NJ. 1. 2. Outline. Meta-Analysis. Indirect Comparisons. Network . Meta-Analysis. Susan . Ellenberg. , Ph.D.. Perelman School of Medicine. University of Pennsylvania . School of Medicine. FDA Clinical Investigator Course. Silver Spring. , . MD. November . 9. , 2016. OVERVIEW. Bias and random error present obstacles to obtaining accurate information from clinical trials. A Look at Cognition and Depressive Symptomatology. Cognitive Performance in Patients With MDD Treated With Vortioxetine Compared With Escitalopram and Venlafaxine. Study Design and Participants. Cognitive Performance in Patients With MDD Treated With Vortioxetine Compared With Escitalopram and Venlafaxine. DerSimonian and Nan Laird paper examines eight published reviews each reporting results from several related trials. Each review pools the results from the relevant trials in order to evaluate the ef Clinical trials . are required in the development of . new . medicines and improved treatments . for . patients. . The . information that clinical trials generate on the efficacy and safety of . treatments . Prepared for:. Agency for Healthcare Research and Quality (AHRQ). www.ahrq.gov. This presentation will:. Summarize prior knowledge on treatment-effect modifiers and reference sources. Prespecify subgroups to be evaluated. to . Subgroup Analyses . in Clinical Trials. Marius Thomas, . Björn. Bornkamp. JSM 2016. Chicago, July 31. st. . 2016. Outline. 2. Motivation. The common . approach in exploratory subgroup analyses. Protocol Training. Ava Puccio, RN, PhD; Anita Fetzick, RN, MSN; Lori Shutter, MD. University of Pittsburgh / UPMC. Subject Identification: Helpful Hints for Screening. Screening for Enrollment. A screening log should be maintained by each site. Conducting a Clinical Trial. Wendy M Kohrt, PhD. Nancy Anschutz Chair in Women’s Health Research. Distinguished Professor of Medicine, Division of Geriatric Medicine. University of Colorado – Anschutz Medical Campus. Anthony Sena. Objectives. Characterize treatment patterns in newly diagnosed RA population from 2000-2018. Compare treatment patterns observed in real-world data to international guidelines (ACR, EULAR). Willy Buys a car. Team Members. Agenda. Outline of the presentation topics to be discussed. (Basically the headlines from the rest of this template.). Problem Statement. The problem statement should be a clear, concise statement of exactly what...