Clinical Trial Design

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1 March 16-17, 2015 Loews Philadelphia Hotel Philadelphia, PA Missing Data in Clinical Trials Discover the most effective strategies to identify, reduce and avoid the pitfalls of incomplete data in your clinical trials. Forum Missing data can seriously compromise the outcome of a clinical trial, possibly affecting regulatory compliance Recent studies have shown that data reanalysis changes 35% of trial conclusions More robust clinical trials can significantly improve your drug s safety and efficacy Overcome critical challenges to ensure a successful clinical trial: 3 Minimize the impact of missing data through better clinical trial design 3 Monitor and reduce incomplete data points during the conduct of your study 3 Take proactive steps to reduce patient dropouts and optimize protocols 3 Develop an effective pre-enrollment plan for collecting and cleaning interim data Missing Data Mitigation Clinical Trial Design Clinical Trial Management Statistical Analysis Learning Objectives: 3 Identify the impact that missing data points have on study conclusions and inferences 3 Learn how your trial results are viewed within the current regulatory climate 3 Employ trial-specific analytical techniques to handle missing data 3 Explore best practices for increasing participant retention and compliance Featured Speakers: Co Chaired by: Terry Katz, Director, Global Management and Statistics, Carol Robertson- Plouch, LRL Strategic R&D Innovations, ELI LILLY AND COMPANY Celestine Hicks, Associate Director, Clinical Data Management, ASTRAZENECA Dr. Roderick Little, Richard D. Remington Distinguished University Professor of Biostatistics, UNIVERSITY OF MICHIGAN, SCHOOL OF PUBLIC HEALTH Dr. Craig Mallinckrodt, Research Fellow, Strategy and Decision Sciences, ELI LILLY Maria Minasian, Principle Sample Strategy Analyst, BRISTOL-MYERS SQUIBB Dr. Lori Post, Center for Medical Informatics, Yale University School of Medicine Bill Potter, Senior Advisor to the Director, NIH, NATIONAL INSTITUTE OF MENTAL HEALTH Patrick Zbyszweski, Senior Director, Clinical Data Management, ONCONOVA THERAPEUTICS exlevents.com/missingdata

2 Missing Data in Clinical Trials Forum Dear Colleague, As you know, a successful clinical trial greatly depends on high-quality, accurate data. However, incomplete data points do occur. This can significantly compromise all areas of the research, from key inferences made to regulatory compliance. Regulatory bodies have provided relatively little guidance on how to deal with the setbacks caused by this problem, and many companies compensate by means of a single set of statistical analysis techniques for every study. This is usually not a comprehensive solution, and needs to be utilized in conjunction with other methods to ensure that a trial s datasets are as robust as possible. The Missing Data in Clinical Trials Forum was designed in response to direct feedback from your colleagues to help you implement the most effective methods to mitigate the dangers of missing data in your company s trials. This conference is designed for professionals in the pharmaceutical, medical device or biotechnology industries involved with the following: Clinical Operations Data/Document Management Clinical Quality Management Compliance Clinical Statistics Clinical Trial Monitoring Patient Recruitment Clinical Data Science Medical Research Project Management Data Analysis Strategic R&D Innovations This event is also of interest to: Contract Research Organizations Clinical Trial Management Software Providers Data Concurrency Service Providers Over these two days, our key areas of focus will be: Identifying the impact of missing data on study results Minimizing the impact of missing data through better clinical trial design Employing the most appropriate analytical techniques specific to your study s design Learning best practices for increasing patient participation and compliance This forum is the first of its kind in the clinical trial conference landscape. It is the only event to help you identify and address weak points during all stages of a study, including trial design, operations, monitoring and analysis. Our faculty represents an incredible spectrum of expertise. You are sure to leave this conference with innovative, readily employable techniques to vastly improve the quality of your trials. We look forward to welcoming you to Philadelphia this March! Sincerely, Sponsorship and Exhibiting Opportunities Do you want to spread the word about your organization s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event or distribute promotional items to attendees. ExL works closely with you to customize a package that suits all of your needs. To learn more about these opportunities, contact Andrew Ferguson, Business Development Manager, by calling or ing Stephen Grosso, M.S. Conference Production Director Venue: Loews Philadelphia Hotel 1200 Market Street Philadelphia, PA If you require overnight accommodations, please contact the hotel to book your room. ExL Pharma has reserved a block of rooms at a discounted rate for conference participants. We encourage participants to make reservations by February 23, To make reservations guests can call and request the negotiated rate for ExL s March Meetings. Please book your room early as rooms available at this rate are limited.

3 Monday, March 16, 2015 Day 1 8:00 Registration and Continental Breakfast 9:00 Conference Co-Chairpersons Opening Remarks Keynote 9:15 Overview of the Current State of Missing Data Mitigation and Its Impact on Life Science Companies Review innovations in mitigation techniques Learn how incomplete data affects conclusions and inferences of trials Discover how statisticians can partner with clinical teams to achieve better analyses Bill Potter, Senior Advisor to the Director, NIH, NATIONAL INSTITUTE OF MENTAL HEALTH 10:00 Develop an Operational Strategy to Ensure Effective Trial Practices and Quality Decision-Making Hear best practices regarding project management, budgeting, resources and developing SOPs Ensure that study teams meet all data quality deliverables and metrics Implement effective documentation and communication for improved outcomes Colin Scott, Clinical Project Leader, NOVARTIS CONSUMER HEALTH 10:45 Networking Break 11:15 Optimize Trial Design and Conduct to Minimize the Occurrence of Missing Data Explore study site selection criteria for a better trial Discuss informed consent and distinguishing the difference between withdrawing from the treatment and withdrawing from the study Utilize simulations to identify the probability of success 1:45 Use Emerging Technology to Improve Clinical Sample Tracking Identify the need to increase collaboration and transparency between all parties involved Learn how to streamline processes and take a proactive approach to clinical sample tracking Leverage technology to optimize clinical sample tracking Maria Minasian, Principle Sample Strategy Analyst, BRISTOL-MYERS SQUIBB 2:15 Best Practices for Improving the Quality of Safety Data Reporting in Your Study Reduce dropout rates by improving awareness and training for study site personnel Optimize adverse event reporting and reduce follow-up questions for site and sponsor Improve reporting of safety events for more comprehensive datasets Gerson Peltz, Senior Medical Director, Head of Clinical Trial Safety, BIOGEN IDEC 3:00 Networking Break 3:30 Proven Insights to Increase Patient Recruitment and Retention Identify populations most likely to remain in the study Re-evaluate study endpoints so they are disease-specific Learn how to effectively overhaul data collection methods Discover how budget allocations for patients can increase data completion Dr. Lori Post, Associate Professor, Center for Medical Informatics, YALE UNIVERSITY SCHOOL OF MEDICINE PANEL DISCUSSION 4:15 Monitor and Reduce Missing Data During the Conduct of Your Clinical Trial Utilize remote EDC monitoring methods Harness information extracted from electronic health records Learn how to take a proactive approach to minimize or reduce data being excluded from analyses at the point of collection 12:00 Best Practices for Efficient Data Entry/Management to Mitigate the Effects of Missing Data Learn how to tailor treatment selection appropriately for your trial Manage the challenges associated with esource datasets Learn how to adjust inclusion/exclusion criteria Deborah Rittenhouse, Senior Manager, Clinical Data Management, CSL BEHRING 5:00 Conference Co-Chairpersons Day One Remarks 5:15 Conclusion of Day One 12:45 Luncheon

4 Tuesday, March 17, 2015 Day 2 8:00 Continental Breakfast 9:00 Conference Co-Chairpersons Recap of Day One 9:15 Overview of the Current Regulatory Landscape and Anticipating the Future Learn how incomplete data affects regulatory approval or denial Compile and present trial documentation to increase compliance Discuss clinical trial design from a regulatory viewpoint Celestine Hicks, Associate Director, Clinical Data Management, ASTRAZENECA 10:00 Develop an Effective Pre-Enrollment Plan for Collecting and Cleaning Interim Data Create a cross-functional quality-by-design approach to ensure that all critical data is prioritized and accounted for Discuss tools that can be used to aid in the process and highlight missing or unclean data Identify potential pitfalls or missteps due to CTMS, CRF or matrix designs Patrick Zbyszewski, Senior Director, Clinical Data Management, ONCONOVA THERAPEUTICS case study 10:45 Networking Break 11:15 Learn How to Utilize the Best Imputation Method for Your Application Explore techniques, including last observation carried forward (LCOF), baseline observation carried forward (BCOF), responder analysis and survival analysis, in order to accurately process your trial s datasets Learn how to utilize generalized estimating equations Discover how to use all available data to increase trial accuracy Raj Bandaru, Informatics Science Director, ASTRAZENECA 12:00 Characterize Missing Data Mechanisms to Optimize Primary Analyses Learn how to characterize missing data points as either missing completely at random (MCAR), missing at random (MAR) or missing not at random (MNAR) Identify the patterns of patient dropouts Discover acceptable and unacceptable analytic methods for each analysis type Dr. Craig Mallinckrodt, Research Fellow, Strategy and Decision Sciences, ELI 12:45 Luncheon 1:45 Modern Developments in Sensitivity Analyses Hear an overview of the different types of sensitivity analyses and learn how to use the most appropriate model for examining the robustness of your trial s conclusions Learn how to report the findings of a sensitivity analysis to add credibility to your trials Discuss emerging solutions that can enhance analyses Dr. Roderick Little, Richard D. Remington Distinguished University Professor of Biostatistics, UNIVERSITY OF MICHIGAN, SCHOOL OF PUBLIC HEALTH 2:30 Missing Data Mitigation Techniques from a CRO s Perspective Hear examples of how multiple imputation can minimize data loss Learn about control-based multiple imputation for primary and sensitivity analyses Use mixed models and learn how to view the generated results 3:15 Conference Co-Chairpersons Closing Remarks 3:30 Conclusion of Conference Great overview and sessions on key new areas for recruitment and risk management! - Executive Director, Clinical Operations, Acorda Therapeutics Surpassed my expectations Excellent conference! - Associate Director, Global Inspection Lead, Merck & Company Very useful to get together with others working in the same area and to see the vendors/services available. - Sr. Clinical Research Associate, Momenta Pharmaceuticals

5 Pricing BIRD PRICING Register by January 30, 2015 Conference: $1,795 REGISTRATION INFORMATION STANDARD PRICING Register After January 30, 2015 Conference: $1,995 ONSITE PRICING Conference: $2,195 q YES! Register me for this conference! Name: Title: Company: Dept: Address: City: State: Zip: Phone: Fax: Card Type: q MasterCard q Visa q AMEX Card Number: Exp. Date: Name on Card: Signature: Cancellation and Refund Policy If you need to cancel your registration for an upcoming ExL event, please note the following policies derived from the Start Date of the event: Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 12 months from the voucher issue date. Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date. If you cancel at any time after receiving the conference documentation, the voucher issued will be $395 less. Substitution Charges: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference. ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare hotel or any other costs incurred by registrants. GROUP DISCOUNT PROGRAMS: *Offers may not be combined. Early Bird rates do not apply.* BIRD Save 25% per person when registering SPECIAL SAVE four. 25% For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four at one time). ExL Events liability is limited BIRD to the conference registration fee in the event of a cancellation and does SPECIALnot include changes BIRD SPECIAL in program date content speakers or venue. * The opinions of ExL speakers do not necessarily reflect those of the companies they represent, nor ExL Events, Inc. BIRD Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, BIRD significant effort to find a SPECIAL suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL Events, Inc. s ( ExL s ) designated speakers and is designed for informational purposes for its attendees, and is NOT INTENDED for purposes of copywriting, or for redistribution to other outlets without the express written permission of ExL s designated speaking parties. Neither ExL nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS, INC. EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY THE CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of or endorse the views or opinions given by any third party content provider. ExL presentations may point to other Internet sites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites. BIRD Questions? Comments? Do Terms you and have Conditions a question or comment you would By registering like to be for addressed an ExL Events, at this Inc. event? ( ExL Pharma ) event, you agree Would to the following you like to set get of involved terms and as conditions a listed below: speaker Registration or discussion Fee: leader? Please The fee includes the Program the conference Director, all program materials and designated Stephen continental Grosso, breakfasts at lunches and refreshments.

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