PPT-Critical Issues in the Exploration of Endpoints for Pivotal Clinical Trials to Treat AUD
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Daniel Falk PhD Discussant Division of Treatment and Recovery Research National Institute on Alcohol Abuse and Alcoholism Presented at the Measures of Outcome for
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Critical Issues in the Exploration of Endpoints for Pivotal Clinical Trials to Treat AUD: Transcript
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. 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. 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. 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. CLINICAL TRIALS IN THE TWENTY-FIRST CENTURY: ONGOING CHALLENGES AND EMERGING ISSUES Susan S. Ellenberg , Ph.D. University of Pennsylvania SCT/ICTMC Joint Meeting Liverpool, UK May 8, 2017 CLINICAL TRIALS TIMELINE 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. Page 53 of 60 Ralf‐Dieter Hilgers*, Franz KönigDepartment of Medical Statistics, RWTH Universit Aachen, Pauwelstr 30, D‐ 52074 Aachen, Germany Dr. RalfDieter Hilgers, Department of Medical Statis 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.. 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.
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