PPT-Blinded Sample Size Re-estimation in a Phase III Study Investigating Progression Free

David Morgan Kings College London Consultant formerly Ipsen Nilani Liyanage Ipsen Alison Langley Consultant formerly Ipsen PSI Scientific Meeting on Sample Size Reestimation London 2 November 2016. Study Design and Sample Size. Ideally we are involved in a study from the beginning. As statisticians (an epidemiologist) part of our role is to ensure the study is designed to address the primary hypothesis under consideration. Presented by :Dr. . Reshma.S. . Moderator : Dr. . Subodh. S Gupta. Why do we need sample size calculation?. When should we calculate sample size?. Basic principles for sample size calculation. Derivation of sample size formula. David Morgan (King’s College, London / Consultant – formerly Ipsen). Nilani. . Liyanage. (Ipsen). Alison Langley (Consultant – formerly Ipsen). PSI Scientific Meeting on Sample Size Re-estimation: London: 2 November 2016. –. some random observations. PSI, 2. nd. November 2016. Simon Day. s. imon.day@CTCT-Ltd.co.uk. The plan. …. I was an author on one of the very early papers on sample size re-estimation (Birkett and Day, . Designing your trial for success. Elizabeth Garrett-Mayer, PhD. Professor of Biostatistics. Hollings Cancer Center, Medical University of South Carolina. Golden rule of clinical trials. “Perform a study that will answer an important clinical question with reasonabl. ) - 2012. J. Jack Lee, Ph.D.. Department of Biostatistics. University of Texas . M. D. Anderson Cancer Center. How many patients are needed in a clinical trial?. It depends on what you want to achieve.. Ezra W Cohen University of California, San Diego RTP ON DEMAND: Thyroid Cancer Thyroid Cancer Newly Detected 2015 (n = 62,450) Cancer Facts & Figures 2015. Hürthle Five- and 10-Year Cumulative Incidences of Death Among Patients with Thyroid Cancer Richard S. Finn, MD. Professor of Clinical Medicine. Division of Hematology/ Oncology. Director, Signal Transduction and Therapeutics Program. Jonsson. Comprehensive Cancer Center at UCLA. Geffen School of Medicine at UCLA. Brad Rechtzigel Kohei Osterloth. "The gold standard for evaluating a new intervention" . -Allen Hackshaw. Main topics. What is Phase III?. What are the objectives?. What are the outcomes? . How large should the sample sizes be ?. Lead Researcher. FDA Guest Speaker. Guest Lecturer. Webinar Host. HOSTED BY: . Ronan Fitzpatrick. Webinar Overview. Introduction to Adaptiv. e Design. Adaptive Design Regulatory Context. Sample Size Re-estimation & Worked Example. nQuery. Lead Researcher. FDA Guest Speaker. Guest Lecturer. Webinar Host. HOSTED BY: . Ronan Fitzpatrick. Webinar Overview. Adaptive Designs and Sample Size Re-estimation (SSR). Blinded Sample Size Re-estimation . : . Grant . Writing for Cancer Studies . Masha Kocherginsky, PhD. Professor of Biostatistics, Departments of Preventive Medicine. Director, Quantitative Data Sciences Core, Lurie Cancer Center. Northwestern University. By: Harrison . Reeder. Mentor: Dr. Kathryn . Chaloner. Iowa Summer Institute in Biostatistics. Outline. What exactly does that title mean?. Basic Clinical Trial design. Interim Monitoring for Efficacy. Progression-Free Survival of Isa-. KRd. in High-Risk Newly Diagnosed Multiple Myeloma – Additional Data From Planned Interim Analysis of the GMMG-CONCEPT Trial. Lisa B. Leypoldt. , Diana Tichy, Britta .