Center for Clinical Trials, Berman Institute of Bioethics and The Institute for Clinical and Translational Research at Johns Hopkins present Data and Safety Monitoring Boards: Skills Building Workshop Thursday, October 22, 2009 West Lecture Hall • Pre-Clinical Teaching Building The Johns Hopkins University School of Medicine Dear Prospective Participant: The Data Safety Monitoring Board (DSMB) plays a critical role in augmenting clinical research, by providing specialized and objective oversight of study data that is attentive of human subject safety and data integrity. Moreover, it is the DSMB’s often exclusive access to study data that engenders a unique perspective to gauge study progress, conduct, and outcomes. DSMBs are increasingly seen as indispensible mechanisms to improving clinical research. At The Johns Hopkins University, we are seeking to address this demand, by offering the Data Safety Monitoring Boards: Skills Building Workshop. Further, because the course’s faculty represents the highest level of expertise and experience with DSMB formulation and operation, the Workshop is an incomparable resource. In addition to learning about the fundamentals of DSMBs, it is my hope that you will feel prepared and confident to accept membership into a DSMB or convene your own. So, on behalf of The Johns Hopkins University School of Medicine, Center for Clinical Trials, Berman Institute of Bioethics and The Institute for Clinical and Translational Research at Johns Hopkins, I encourage you to take advantage of this unique workshop. Sincerely, Daniel E. Ford, MD, MPH Vice Dean for Clinical Investigation Description Clinical trials are subject to many types of oversight, including careful monitoring and evaluation of the study protocol, study progress and safety. Further, federal policies require that many clinical trials have data and safety monitoring plans, which often involve data and safety monitoring boards (DSMBs) or data and safety monitoring committees. However, given the lack of established standards, variable policies and general inexperience with data and safety monitoring, investigators are faced with difficulties in designing, initiating and conducting effective data and safety monitoring plans or serving on DSMBs. Similarly, those assembling DSMBs face substantial challenges in identifying persons with expertise and experience to serve on them. To address these needs, The Johns Hopkins University Center for Clinical Trials, Berman Institute of Bioethics and The Institute for Clinical Translational Research present a one-day workshop designed to address key concepts in data and safety monitoring of clinical trials. Topics include the ethical and historical bases for data and safety monitoring, the key components of monitoring plans and the structure and functions of DSMBs. This workshop should benefit those designing and sponsoring clinical trials as well as those interested in serving on DSMBs. Who Should Attend This activity is intended for clinical investigators engaged in clinical research and individuals serving or planning to serve on data and safety monitoring boards. Objectives After attending this activity, the participant should be able to: • Recognize the historical foundations and need for data and safety monitoring in the context of research ethics • Differentiate the roles and responsibilities of the members of the data and safety monitoring board • Describe the key components of data and safety monitoring plans concerning the analysis on study and safety data and their respective impacts of scientific integrity and human subject safety • Identify the main considerations in assembling a data and safety monitoring board and designing and implementing a comprehensive charter. Policy on Speaker and Provider Disclosure It is the policy of The Johns Hopkins University School of Medicine that the speaker and provider disclose real or apparent conflicts of interest relating to the topics of this educational activity, and also disclose discussions of unlabeled/unapproved uses of drugs or devices during their presentation(s). The Johns Hopkins University School of Medicine OCME has established policies in place that will identify and resolve all conflicts of interest prior to this educational activity. Detailed disclosure will be made in the activity handout materials. General Information Registration Thursday, October 22, 2009 • 8:00 - 8:30 am Location West Lecture Hall Pre-Clinical Teaching Building The Johns Hopkins University School of Medicine 725 N. Wolfe Street Baltimore, Maryland 21205 The Pre-Clinical Teaching Building is located on Wolfe Street at Monument Street. Directions and campus parking information are available on our website under the contact and travel section at www.HopkinsCME.edu. Handicapped parking is available in the nearby Washington Street Garage. Johns Hopkins is smoke-free. Fees REGISTRATION CUT-OFF DATE: October 17, 2009 Methods of Payment: Payment by check or credit card only must accompany registration form prior to the activity. On-site payments by credit card only. Foreign payments must be by credit card or with a U.S. Dollar World Money Order. The registration fee includes instructional materials, continental breakfast, refreshment breaks and lunch. Registration $450 You will receive a confirmation by e-mail if you have provided your e-mail address. Otherwise, confirmation will be sent by mail. If you have not received it by October 17, 2009, call (410) 502-9634 to confirm that you are registered. Certificates of attendance will be mailed by December 6, 2009 The Johns Hopkins University reserves the right to cancel or postpone any activity due to unforeseen circumstances. In this event, the University will refund the registration fee but is not responsible for travel expenses. Additionally, we reserve the right to change the venue to a comparable venue. Under such circumstances registrants will be notified as soon as possible. Late Fee and Refund Policy A $50 late fee applies to registrations received after 5:00 p.m. EST on October 17, 2009. A handling fee of $50 is deducted for cancellation. Refund requests must be received by fax or mail by October 17, 2009. No refunds will be made thereafter. Transfer of registration to another Johns Hopkins conference in lieu of cancellation is not possible. Americans with Disabilities Act The Johns Hopkins University School of Medicine fully complies with the legal requirements of the ADA and the rules and regulations thereof. Please notify us if you have any special needs. To Register or for Further Information Register Online www.HopkinsCME.edu Register by Phone (410) 502-9634 Register by Fax (866) 510-7088 Confirmation/Certificates (410) 502-9634 General Information (410) 955-2959 E-mail the Office of CME cmenet@jhmi.edu Sponsoring Department Website: http://ictr.johnshopkins.edu/client/index.cfm For general information, the direct link for this CME activity web page is: www.hopkinscme.edu/CourseDetail.aspx/80022873 Data and Safety Monitoring Boards: Skills Building Workshop Thursday, October 22, 2009 Program 8:00 - 8:30 Registration and Continental Breakfast 8:30 - 9:00 Welcome and Conference Goals Kay Dickersin, PhD, MA, Steven Goodman, MD, MHS, PhD, Jeremy Sugarman, MA, MPH, MA 9:00 - 10:00 History and Ethics of Oversight of Clinical Trials Jeremy Sugarman, MD, MPH, MA 10:00 - 10:15 Refreshment Break 10:15 - 11:00 Basic Structure and Function of DSMBs Kay Dickersin, PhD, MA 11:00 - 11:45 Evaluating Interim Data Steven Goodman, MD, MHS, PhD 11:45 - 1:00 Lunch 1:00 - 1:45 Panel Discussion: Perspectives and Experience with DSMBs Moderator: Jeremy Sugarman, MD, MPH, MA Panelists: Joseph Collins, ScD, David Cornblath, MD, Kay Dickersin, PhD, MA, Steven Goodman, MD, MHS, PhD, Barbara Hawkins, PhD, Frederick Luthardt, MA, MA, CCRP, Rosemary Rosso, JD 1:45 - 3:15 Practical Group Exercise: Case Studies Moderator: Steven Goodman, MD, MHS, PhD Group Facilitators: Joseph Collins, ScD, David Cornblath, MD, Kay Dickersin, PhD, MA, Barbara Hawkins, PhD, Frederick Luthardt, MA, MA, CCRP, Rosemary Rosso, JD, Jeremy Sugarman, MD, MPH, MA 3:15 - 3:30 Refreshment Break 3:30 - 4:30 Questions and Program Summary Jeremy Sugarman, MD, MPH, MA 4:30 Adjourn – Please complete and return the Evaluation and Credit Report Form The Johns Hopkins University School of Medicine takes responsibility for the content, quality and scientific integrity of this CME activity. This schedule is subject to change. Speakers Activity Co-Directors Kay Dickersin, PhD, MA Professor of Epidemiology Director, Center for Clinical Trials Steven Goodman, MD, MHS, PhD Professor of Oncology, Pediatrics, Epidemiology and Biostatistics Acting Director, Oncology Biostatistics Editor, Clinical Trials Jeremy Sugarman, MD, MPH, MA Harvey M. Meyerhoff Professor of Bioethics and Medicine Johns Hopkins Faculty David Cornblath, MD Professor of Neurology Barbara Hawkins, PhD Professor Emeritus of Ophthalmology Frederick Luthardt, MA, MA, CCRP Research Subject Advocate Institute of Clinical Translation Research Compliance Specialist Office of Human Subject Research Guest Faculty Joseph Collins, ScD Professor of Epidemiology and Preventive Medicine University of Maryland at Baltimore Senior Associate, The Johns Hopkins University Director, Cooperative Studies Program Coordinating Center Veterans Administration Medical Center Perry Point, Maryland Rosemary Rosso, JD Representative, National Breast Cancer Coalition Washington, D.C. Registration Form Course Number 80022873 Data Safety and Monitoring Boards: Skills Building Workshop • October 22, 2009 To Register: Online: www.HopkinsCME.edu By fax: (866) 510-7088 By phone (credit card only): (410) 502-9634 Or mail this form to The Johns Hopkins University, Office of Continuing Medical Education, P.O. Box 64128, Baltimore, Maryland 21264-4128. Include check payable to HOPKINS/80022873, or include credit card information below. PAYMENT MUST ACCOMPANY FORM TO CONFIRM YOUR REGISTRATION. Please type or print clearly: last name first name middle initial primary degree (for name badge) primary specialty preferred mailing address city state ZIP + 4 code country daytime telephone fax number e-mail / / / / / / / / / / / / / / / / / / / / / / / / / / You will receive confirmation notice by e-mail if you provide your e-mail address. M Check here if you wish to receive e-mail and/or fax notices about upcoming CME activities. What do you hope to learn by attending this activity? Please notify us if you have any special needs. M Registration Fee $450 For registrations received after 5:00 p.m. EST on October 17, 2009, include a $50 late fee. On-site registrations are payable only by credit card. Total amount enclosed $ Payment Type: JHU Faculty/Staff Only: Complete registration form and return with appropriate form below to OCME, Turner 20. M Internal Order Number: The ION Data Request Form, can be found online at http://www.hopkinscme.edu/pdfs/IonRequest.pdf. M Tuition Remission: To apply for TR, go to http://benefits.jhu.edu/EduBenefits/tuitionRemission.cfm. This is a non-credit professional development activity. M Check (See instructions on top of form.) M Credit Card: M VISA M MASTERCARD M DISCOVER M AMEX Card # - - - Exp. Date Name on Card Signature and Date