Held on Thursday, October 20th, 2011 at the Wyndham in Glenview, IL.
The 2011 Fall Workshop of the Northeastern Illinois Chapter of the American Statistical Association presents:
Clinical Trial Methodology
presented by: Karl E. Peace , Ph.D., Professor of Biostatistics in the Jiann-Ping Hsu College of Public Health (JPHCOPH) at Georgia Southern University.
Abstract
A clinical trial is a research study conducted to assess the utility of an intervention in volunteers. Interventions may be diagnostic, preventative or treatment in nature and may include drugs, biologics, medical devices or methods of screening. Interventions may also include procedures whose aim is to improve quality of life or to better understand how the intervention works in volunteers. Clinical trial methodology (CTM) comprises all methods required for the protection of participants in a clinical trial and all methods necessary to provide a valid inference about the objective of the trial. In short, CTM consists of all methods necessary to develop and conduct a quality clinical trial protocol and to provide quality data collection, biostatistical analyses and a clinical study report while maintaining the highest standards of ethics and excellence. Several landmark clinical trials from the presenter’s own experience that led to regulatory approval of drugs (e.g. reducing CHD risk, optimal treatment of DU, prevention of GU, and a parallel bioequivalence trial) will be reviewed from a case study approach with attention to CTM utilized. The presentation is based on: Peace KE, Chen D (2010): Clinical Trial Methodology; Chapman & Hall/CRC, Taylor and Francis Group; ISBN 978-1-5848-8917-5.
Speaker Bio
Dr. Karl E. Peace is the Georgia Cancer Coalition Distinguished Cancer Scholar (GCCDCS), Senior Research Scientist and Professor of Biostatistics in the Jiann-Ping Hsu College of Public Health (JPHCOPH) at Georgia Southern University. He is the architect of the MPH in Biostatistics and Founding Director of the Center for Biostatistics in the JPHCOPH. Dr. Peace holds the Ph.D. in Biostatistics from the Medical College of Virginia, the M.S. in Mathematics from Clemson University, the B.S. in Chemistry from Georgia Southern College, and a Health Science Certificate from Vanderbilt University.
Dr. Peace also had a lengthy career in research, technical support and management in the pharmaceutical industry. He held the positions of Senior Statistician at Burroughs-Wellcome, Manager of Clinical Statistics at A.H. Robins, Director of Research Statistics at SmithKline and French Labs, Senior Director of GI Clinical Studies, Data Management and Analysis, at G.D. Searle, and Vice President of World-Wide Technical Operations at Warner Lambert/Parke-Davis. He then founded Biopharmaceutical Research Consultants, Inc. (BRCI), where he held the positions of President, Chief Executive Officer, and Chief Scientific Officer. Dr. Peace has made pivotal contributions in the development and approval of drugs to treat Alzheimer’s disease, to prevent and treat gastrointestinal ulcers, to reduce the risk of myocardial infarction, to treat anxiety, depression and panic attacks, to treat hypertension and arthritis, and several antibiotics.
Dr. Peace is a member of several professional societies and is the recipient of numerous citations and awards: (1) Georgia Cancer Coalition Distinguished Cancer Scholar, (2) Fellow of the ASA, (3) the Distinguished Service Award of the DIA, (4) Star and Featured Alumnus, School of Basic Sciences, and Founder’s Society Medal from the Medical College of Virginia, (5) College of Science and Technology Alumnus of the year, Alumnus of the year in private enterprise, Presidential Fellowship Award, Researcher of the year awards, and the First Recipient of the prestigious President’s Medal for outstanding service and extraordinary contributions, all from Georgia Southern University, (6) 2007 APHA Statistics Section Award, (7) 2008 Shining Star and HR #2118 recognition by GA House of Representatives, (8) US Congress Citation for contributions to drug research and development and to Public Health, (9) the Tito Mijares Lifetime Achievement Award, (10) the Deen Day Smith Humanitarian Award and (11) several meritorious service awards from the ASQC, BASS and the Georgia Cancer Coalition. He is or has been Chair of: the Biostatistics Subsection of the Pharmaceutical Manufacturers Association (BSPMA), the Training Committee of the BSPMA, the Biopharmaceutical Section of the ASA, the Statistics Section of the APHA, and is Founder of the Biopharmaceutical Applied Statistics Symposium (BASS), now in its 18th year.
Dr. Peace is the author or editor of 10 books and the author or co-author of 200 articles. His primary research interests are: Drug research and development, clinical trial methodology, time-to-event methodology, and public health applications of biostatistics.
Dr. Peace is a renowned philanthropist having created 21 scholarship endowments across 5 educational and public health institutions. Further details of Dr. Peace's accomplishments and contributions may be found in his autobiography: Paid In Full, available at: www.plowboy-press.com.