PPT-Blinded Sample Size Re-estimation in a Phase III Study Inve

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. –. 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. November 17, . 2015. Allen Kunselman, MA. Division of Biostatistics and Bioinformatics. Department of Public . H. ealth Sciences. Quotes. An approximate answer to the right question is worth a good deal more than an exact answer to the wrong question.. Review of Type I & Type II Errors. When we conduct a test of any hypothesis regardless of the test used we make one of two possible decisions:. Reject the null (H. o. ) in favor of the alternative (H. Confidence Intervals on . and. An interval estimator is a formula that tells us how to use sample data to calculate an interval that estimates a population parameter.. The confidence coefficient is the probability that an interval estimator encloses the population parameter.. Consider taking a sample of size n from a large population of seeds of the princess bean (. Phaseotus. . vulgaris. ) and record the seed weights.. If our sample size is 20 and found the mean = 475 mg and s = 75 mg. What is SE?. 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. 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.