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. Daniel J. Sargent, PhD. 1970-2016. Wore Many hats…. Section Head, Cancer Center Statistics, Mayo Clinic. Chair, Division of Biomedical Statistics and Informatics . Director, Biostatistics Shared Resource for the Mayo Clinic Cancer Center. End-points utilized in breast cancer clinical trials - Discussion Novartis Oncology Discussant - Arunava Chakravartty Stat4Onc Symposium , Hartford, CT Apr-26, 2019 Disclaimer All views expressed in the slide represent the individual views of the presenter and should not be seen as representing the views of Novartis, its board or its shareholders. 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. Ashley E. Ross MD PhD. Executive Medical Director. Mary Crowley Cancer Research Centers. NASPCC Annual Meeting 2019. Objectives. Define GCP (Good Clinical Practice) and its applications for patients and research.. FDA Perspective. Marco Cannella, PhD. Senior Lead Reviewer . Cardiac Electrophysiology Devices Branch. FDA – CDRH – Office of Device Evaluation. ISCTR Consensus Summit. San Diego, California. September 21, 2018. Professor Julia . Brown. Leeds Institute of Clinical Trials Research, University of Leeds. Introduction. First clinical trial in 1747, James Lind. Clinical trials are gold standard for the evaluation of new treatments/interventions in health care . 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. . Natalie Dimier and Sue Todd. University of Reading. Pharm Stat. 2017 Sep;16(5):322-333. Agenda. Context. Motivation for the research. Investigation. Set-up. Results. Conclusions. Remaining Questions. of EMA authorized . biosimilars. Session “Biosimilar Development”, 15 May. Johanna . Mielke, Bernd Jilma. , Franz Koenig, . Byron . Jones. Franz König. Medical University of Vienna. Section of Medical Statistics. 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 – . clinical . trials - Discussion. Novartis Oncology. Discussant - . Arunava. . Chakravartty. Stat4Onc Symposium , . Hartford, CT . Apr-26, 2019. Disclaimer. All views expressed in the slide represent the individual views of the presenter and should not be seen as representing the views of Novartis, its board or its shareholders.. 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. 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.