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

Welcome!Welcome!May 18 - 21, 2014

Sheraton Philadelphia Downtown HotelPhiladelphia, PA USA

The Society for Clinical TrialsThe Society for Clinical Trials2014 Corporate Sponsors

35th 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 TrialsThe Society for Clinical Trials2014 Attendees

• 479 Attendees– US– Saudi Arabia– Japan– Australia– Germany– France– United Kingdom– Canada

– Belgium– Italy– Denmark– Switzerland– Korea– Thailand– Netherlands

The Society for Clinical TrialsThe Society for Clinical Trials2014 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 Coffey Co-Chair: Domenic J. Reda

The Society for Clinical TrialsThe Society for Clinical Trials2014 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 TrialsThe Society for Clinical Trials2014 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 Shapiro Co-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– @SCTPres– @SCTorg

The Society for Clinical TrialsThe Society for Clinical TrialsSCT Webinars: Live & Interactive

Free to Members

• 3/18/14 - 58 REGISTRANTS!! Available at SCTweb.orgPresenter: Steve Goodman, MD, MHS, PhDWhy Sharing Clinical Trial Data is So Hard, and Why the IOM Needs your Help

• 6/17/14 (12 – 1 PM Eastern)Presenter: Marc Buyse, ScDRisk Based Monitoring for Clinical Trials

• 8/12/14 (12 – 1 PM Eastern)Presenter: Debra SteinbergWeb-based Event Ascertainment and Outcomes Tracking in a Multi-center Clinical Trial

• 10/14/14 (12 – 1 PM Eastern)Presenter: Janet Wittes, PhDOn data for DMCs: Clean or speedy? Complete or limited?

• 12/9/14 (12 – 1 PM Eastern)Presenter: Ken Cheung, PhDSample Size Determination for Phase 1 Clinical Trials

The Society for Clinical TrialsThe Society for Clinical TrialsMeeting 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 FellowsClass of 2014 FellowsMay 19, 2014


The Society for Clinical TrialsThe Society for Clinical Trials

Ivan S. F. Chan Mary A. FoulkesJoseph F. Collins Theodore Karrison Janet Darbyshire Eleanor McFadden Mark Espeland O. Dale Williams

Chair: Peter Peduzzi

2014 Fellows Committee

Qualifications for FellowshipQualifications for FellowshipCandidates 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, PhDProfessor

Departments of Statistics and of Biostatistics and Medical Informatics

University of Wisconsin - Madison

2014 Fellows

The Society for The Society for Clinical TrialsClinical 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, EDICThe George Washington University


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, PhDProfessor of Biostatistics

Department of Biostatistics and EpidemiologyUniversity of Pennsylvania Perelman School of Medicine


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, PhDProfessor of Biostatistics and Bioinformatics

Duke University School of MedicineLead Faculty Statistician in Genitourinary Cancer

Alliance for Clinical Trials in Oncology


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, PhDPresident

BiostatHaven, Inc.Croton-on-Hudson, NY


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, PhDProfessor of Biostatistics and, by courtesy, of Statistics

Chair, Department of Health Research and PolicyStanford University School of Medicine


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, PHDChair, Department of Emergency Medicine, Harbor-UCLA Medical Center

Professor, David Geffen School of Medicine at UCLASenior Medical Scientist, Berry Consultants, LLC

Senior Investigator, Los Angeles Biomedical Research Institute


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 McDonaldSenior Trials Manager in the Centre for Healthcare Randomised

Trials (CHaRT), Health Services Research Unit (HSRU)University of Aberdeen, U.K.


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 MoritzRetired, formerly Senior Biostatistician

Cooperative Studies Program Coordinating Center (CSPCC)Hines VA Hospital

Hines, IL


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 RushingDirector, Research Information Systems

Division of Public Health SciencesWake Forest University Medical Center


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, PhDProfessor in the Department of Biostatistics

M.D. Anderson Cancer Center


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 FellowsClass of 2014 FellowsMay 19, 2014


Curtis Meinert LectureCurtis Meinert LectureMay 19, 2014


Curtis Meinert Lecture

• Professor, Johns Hopkins – Director, Center for Clinical Trials 1990-2005

• Clinical Trial leadership since 1960s• Founding member, SCT• Founding Editor of SCT Journal Controlled Clinical Trials

(now Clinical Trials), 1980-1993• Inaugural SCT Fellow: 2006• Website: TrialsMeinertsway.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 LectureCurtis Meinert LectureEzekiel J. Emanuel, MD, PhDEzekiel J. Emanuel, MD, PhD

Health Care Reform and the Future of Clinical Research

Welcome!Welcome!May 18 – 21, 2014


Documents

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