PPT-Exploration of Endpoints for Pivotal Clinical Trials to Tre

Raye Z Litten PhD Daniel Falk PhD Discussant Division of Treatment and Recovery Research National Institute on Alcohol Abuse and Alcoholism Presented at the Measures of Outcome for Stimulant Trials MOST meeting of the ACTTION Initiative. Big Data Suite. It’s More Than Just . Hadoop. Pivotal’s. Full Approach. How Pivotal Accelerates . Value Creation. 70% of data generated by customers. 80% of data being stored. 3% being prepared for analysis. Challenging Tradition. Chia-Chi (Josh) Lin, MD, PhD . 林家齊. Director of Phase I Center, Department of Oncology, National Taiwan University Hospital. Clinical Associate Professor, Graduate Institute of Oncology, National Taiwan University College of Medicine. Protocol=study plan which details what researchers will do in the study. It describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. . Susan S. . Ellenberg. , Ph.D.. University of Pennsylvania. SCT/ICTMC Joint Meeting. Liverpool, UK. May 8, 2017. CLINICAL TRIALS TIMELINE. 1948: First randomized clinical trials of modern era. 1962: Amendments to U.S. Food, Drug and Cosmetic Act requiring demonstration of efficacy as well as safety. Elaine M Pascoe, Darsy Darssan, Liza A Vergara. Australasian Kidney Trials Network. The University of Queensland. . Overview. Covariate adaptive randomization. Minimization example. Minimization issues. Stephanie Cook. Rachel Feldman. Noel Ramsey. Cody . Yager. Group 5 “The Fun Table”. ICARE TTI: May 1-4, 2017. Audience – PIs writing protocols for the . first . time. GOAL. Understand the concepts of pain, distress, and humane endpoints in animals. . ®. and How it Maps onto Discrete Trial Training. By Amelia . Mcclelland. Superheroes Social . S. kills . T. raining, Rethink Autism Internet . I. nterventions, Parent . T. raining, EBP Classroom . T. Susan S. . Ellenberg. , Ph.D.. University of Pennsylvania. SCT/ICTMC Joint Meeting. Liverpool, UK. May 8, 2017. CLINICAL TRIALS TIMELINE. 1948: First randomized clinical trials of modern era. 1962: Amendments to U.S. Food, Drug and Cosmetic Act requiring demonstration of efficacy as well as safety. Generated by Mobile Technology for . Use in Clinical Trials*. *The term “clinical trial” is used here to refer to studies done to support regulatory approval for marketing. . Source: Clinical Trials Transformation Initiative’s . . By . Trusha Patel and Sirisha . Davuluri. “An efficient method for accommodating potentially underpowered primary endpoints” . By . Jianjun. (David) Li. . and . Devan. V. . Mehrotra. ”. Article Details. History, Current Regulations , and Future Considerations by Kalindi Naik Project Submitted to the School of Health Sciences Eastern Michigan University in partial fulfillment of the requirements for Elektra Papadopoulos, . FDA/CDER. Lindsay Kehoe, . CTTI. Brian Perry, . CTTI. July 27, 2021. Digital health technology-derived clinical outcome assessments: considerations for regulatory decision-making. RWD. Frank W. Rockhold, PhD. Professor of Biostatistics and Bioinformatics. Duke University Medical Center. Duke/Stanford CEC Summit. September 26-27, 2018, Chicago, Il. Disclosure. Statement – . Raye Z. Litten, Ph.D.. Daniel Falk, Ph.D. (Discussant). Division of Treatment and Recovery Research. National Institute on Alcohol Abuse and Alcoholism. Presented at the Measures of Outcome for Stimulant Trials (MOST) meeting of the ACTTION Initiative.