Welcome! May , 2014 Sheraton Philadelphia Downtown Hotel Philadelphia, PA USA

The Society for Clinical Trials 2014 Corporate Sponsors

35 th Annual Meeting First annual meeting: 1980, Philadelphia Keynote speaker: Donald Fredickson, NIH Director International participation Topics – Ethics – Subgroup analysis – Experimental Design – Meta-Analysis – Data Quality – Recruitment and Adherence The more things change, the more they stay the same

The Society for Clinical Trials 2014 Attendees 479 Attendees – US – Saudi Arabia – Japan – Australia – Germany – France – United Kingdom – Canada – Belgium – Italy – Denmark – Switzerland – Korea – Thailand – Netherlands

The Society for Clinical Trials 2014 Program Committee Vladimir Dragalin Valerie Durkalski William E. Elgie Mike Hale Gordon Hughes James Kaufman Marianne Kearney Beverly Koski Ellen Long Leslie Ain McClure William J. Meurer Oscar Moreno Kristine M. Nelson Vlado Perkovic Paul A. Thompson Marc Walton Chair: Christopher CoffeyCo-Chair: Domenic J. Reda

The Society for Clinical Trials 2014 Pre-Conference Workshops 11 workshops 156 Workshop registrations Hot topics: – IDMCs for trials with adaptive designs – Enrichment strategies for clinical trials

The Society for Clinical Trials 2014 Education Committee Kousick Biswas Li Chen Suzanne Firrell Virginia J. Howard Tassos Kyriakides Oscar Moreno Wendy R. Parulekar Domenic J. Reda Yves D. Rosenberg Emily Van Meter Chair: Stan ShapiroCo-Chair: Paul Wakim

SCT Social/Mobile SCT 2014 Mobile App by Grupio - Available for download on the following devices: iPhone/iPad Android Blackberry Storm and Torch - Agenda (with real-time updates), maps, speakers, more Twitter: #SCT2014

The Society for Clinical Trials SCT Webinars: Live & Interactive Free to Members 3/18/ REGISTRANTS!! Available at SCTweb.org Presenter: Steve Goodman, MD, MHS, PhD Why Sharing Clinical Trial Data is So Hard, and Why the IOM Needs your Help 6/17/14 (12 – 1 PM Eastern) Presenter: Marc Buyse, ScD Risk Based Monitoring for Clinical Trials 8/12/14 (12 – 1 PM Eastern) Presenter: Debra Steinberg Web-based Event Ascertainment and Outcomes Tracking in a Multi-center Clinical Trial 10/14/14 (12 – 1 PM Eastern) Presenter: Janet Wittes, PhD On data for DMCs: Clean or speedy? Complete or limited? 12/9/14 (12 – 1 PM Eastern) Presenter: Ken Cheung, PhD Sample Size Determination for Phase 1 Clinical Trials

The Society for Clinical Trials Meeting Highlights Lunches – Included in meeting registration! Reception tonight (6:30) – Included in meeting registration! 24 Invited, 25 contributed paper sessions – New Topic Contributed Sessions: Tuesday 2:15-3:45 4:00 PM Tuesday: SCT Trial of the Year 11:00 AM Wednesday: Founders Lecture – Christopher P. Austin, MD, Director, National Center for Advancing Translational Sciences

Class of 2014 Fellows May 19, 2014 Sheraton Philadelphia Downtown Hotel Philadelphia, PA USA

The Society for Clinical Trials Ivan S. F. Chan Mary A. Foulkes Joseph F. Collins Theodore Karrison Janet Darbyshire Eleanor McFadden Mark Espeland O. Dale Williams Chair: Peter Peduzzi 2014 Fellows Committee

Qualifications for Fellowship Candidates must have been an SCT member for a total of 10 years, or five of the last 10 years. Each nominee was evaluated by the Committee on the basis of contributions to the advancement of clinical trials in one or more of the following areas: Methodologic development Coordination, conduct, or leadership of individual clinical trials Education Ethics Promotion of a better understanding by the general public of the importance of randomized clinical trials Service to the Society

Rick Chappell, PhD Professor Departments of Statistics and of Biostatistics and Medical Informatics University of Wisconsin - Madison 2014 Fellows

The Society for Clinical Trials 2014 Fellows Rick Chappell, PhD: For important contributions to the statistical methodology for the design and analysis of clinical trials, particularly in cancer and aging; for leadership in clinical trial coordination and conduct at the University of Wisconsin Comprehensive Cancer Center; for national leadership on numerous DSMBs and advisory committees, including NIH and FDA; and for distinguished service to the Society.

2014 Fellows Patricia A. Cleary, M.S. Co-Principal Investigator/Director The Biostatistics Center, EDIC The George Washington University

The Society for Clinical Trials 2014 Fellows Patricia A. Cleary, M.S.: For outstanding leadership over the past 30 years as Director of the Data Coordinating Center for the landmark Diabetes Control and Complications Trial (DCCT), and its long-term follow-up study of the Epidemiology of Diabetes Interventions and its Complications (EDIC); for leadership of other important studies including the Optic Neuritis Treatment Trial; for service as an advisor to the National Institutes of Health, particularly the National Eye Institute; and for service to the Society.

2014 Fellows Jonas H. Ellenberg, PhD Professor of Biostatistics Department of Biostatistics and Epidemiology University of Pennsylvania Perelman School of Medicine

The Society for Clinical Trials 2014 Fellows Jonas H. Ellenberg, PhD: For major contributions to the science and practice of clinical trials, including his advocacy for and design, conduct and analysis of a trial that changed clinical practice for children with febrile seizures; for his publications supporting the principles of randomized trials; for his development of a highly successful conference series on statistical methods in clinical trials; and for long service to the Society.

2014 Fellows Susan Halabi, PhD Professor of Biostatistics and Bioinformatics Duke University School of Medicine Lead Faculty Statistician in Genitourinary Cancer Alliance for Clinical Trials in Oncology

The Society for Clinical Trials 2014 Fellows Susan Halabi, PhD: For her outstanding leadership in cancer clinical trials and prognostic development, particularly her work in the Cancer and Leukemia Group B (CALGB), now part of the Alliance for Clinical Trial in Oncology, that focused on genitourinary cancers in which she designed and analyzed dozens of clinical trials that have informed new treatment approaches for prostate cancer and other GU malignancies, identified important associations between biological factors and treatment outcomes and impacted the quality of life of cancer patients; for her educational activities; and for dedicated service on national review committees, DSMBs and scientific advisory committees and for the SCT.

2014 Fellows Ed Lakatos, PhD President BiostatHaven, Inc. Croton-on-Hudson, NY

The Society for Clinical Trials 2014 Fellows Ed Lakatos, PhD: For his participation and leadership on a number of pivotal clinical trials; for his mentorship and development of statistical departments within the pharmaceutical industry; for his methodological contributions, especially Markov methods and statistical software for sample size calculation in the presence of non- proportional hazards; and for his service to the Society.

2014 Fellows Philip William Lavori, PhD Professor of Biostatistics and, by courtesy, of Statistics Chair, Department of Health Research and Policy Stanford University School of Medicine

The Society for Clinical Trials 2014 Fellows Philip William Lavori, PhD: For seminal methodological contributions to the science of clinical trials, particularly in the area of dynamic treatment regimes; for outstanding leadership in clinical trials as the Director of the VA Cooperative Studies Program Coordinating Center, Palo Alto, CA and as Interim Director of the national VA Cooperative Studies Program; and for service to the Society.

2014 Fellows Roger J. Lewis, MD, PHD Chair, Department of Emergency Medicine, Harbor-UCLA Medical Center Professor, David Geffen School of Medicine at UCLA Senior Medical Scientist, Berry Consultants, LLC Senior Investigator, Los Angeles Biomedical Research Institute

The Society for Clinical Trials 2014 Fellows Roger J. Lewis, MD, PhD: For his contributions to the advancement of clinical trials as an ambassador to the emergency medicine scientific community; for methodology development; for trial coordination, conduct and leadership; for education; and for service to the Society.

2014 Fellows Alison McDonald Senior Trials Manager in the Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit (HSRU) University of Aberdeen, U.K.

The Society for Clinical Trials 2014 Fellows Alison McDonald: For leadership in the management and coordination of clinical trials; for training and education of trial managers, particularly in the UK; for contributions to research in trial management methodology, and for service to the Society.

2014 Fellows Tom Moritz Retired, formerly Senior Biostatistician Cooperative Studies Program Coordinating Center (CSPCC) Hines VA Hospital Hines, IL

The Society for Clinical Trials 2014 Fellows Tom Moritz: For his contributions to the conduct of clinical trials; for methodological development; for trial coordination and leadership through the national VA Cooperative Studies Program; and for his long and dedicated service to the Society.

2014 Fellows Scott Rushing Director, Research Information Systems Division of Public Health Sciences Wake Forest University Medical Center

The Society for Clinical Trials 2014 Fellows Scott Rushing: For leading the development of innovative computerized data management systems for many major clinical trials; for educating and mentoring generations of programmers and trialists; and for providing extensive and longstanding service to the Society, including membership on its Board of Directors and other Society committees and scientific panels.

2014 Fellows Peter F. Thall, PhD Professor in the Department of Biostatistics M.D. Anderson Cancer Center

The Society for Clinical Trials 2014 Fellows Peter F. Thall, PhD: For his outstanding statistical methodological contributions, including work on screening/testing designs and the development of Bayesian-adaptive designs for early-phase cancer clinical trials; for his in-depth collaboration on numerous oncology trials; for his teaching and mentorship of young statisticians; and for his contributions and service to the Society.

Class of 2014 Fellows May 19, 2014 Sheraton Philadelphia Downtown Hotel Philadelphia, PA USA

Curtis Meinert Lecture May 19, 2014 Sheraton Philadelphia Downtown Hotel Philadelphia, PA USA

Curtis Meinert Lecture Professor, Johns Hopkins – Director, Center for Clinical Trials Clinical Trial leadership since 1960s Founding member, SCT Founding Editor of SCT Journal Controlled Clinical Trials (now Clinical Trials), Inaugural SCT Fellow: 2006 Website: TrialsMeinertsway.comTrialsMeinertsway.com

Ezekiel J. Emanuel, MD PhD University of Pennsylvania – Vice Provost for Global Initiatives – Diane V.S. Levy and Robert M Levy University Professor – Chair: Department of Medical Ethics and Health Policy Founding Chair: Department of Bioethics, NIH Special Advisor on Health Policy to Director of the Office of Management and Budget and National Economic Council Contributor: New York Times

Curtis Meinert Lecture Ezekiel J. Emanuel, MD, PhD Health Care Reform and the Future of Clinical Research

Welcome! May 18 – 21, 2014 Sheraton Philadelphia Downtown Hotel Philadelphia, PA USA