march 16-17, 2015 • loews philadelphia hotel...

Missing Data in Clinical Trials

Discover the most effective strategies to identify, reduce and avoid the pitfalls of incomplete data in your clinical trials.

Missing DaTa MiTigaTiOn

exlevents.com/missingdata

March 16-17, 2015 • Loews Philadelphia Hotel • Philadelphia, PA

• 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

Forum

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

Terry Katz, Director, Global Management and Statistics, MeRCK

Carol Robertson-Plouch, LRL Strategic R&D Innovations, eLi LiLLy anD COMPany

Co–Chaired by:

FeaTuReD sPeaKeRs:

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

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

Clinical Trial Managemen

t s

tatistical analysis

Clin

ical Trial Design

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.

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,

Stephen Grosso, M.S.Conference Production [email protected]

Missing Data in Clinical TrialsForum


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

Venue: Loews Philadelphia Hotel1200 Market Street Philadelphia, PA 19107

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, 2015. To make reservations guests can call 888-575-6397 and request the negotiated rate for “ExL’s March Meetings.” Please book your room early as rooms available at this rate are limited.

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 917-258-5150 or emailing [email protected] .

Monday, March 16, 2015 Day 1


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8:00 Registration and Continental Breakfast

9:00 Conference Co-Chairpersons’ Opening RemarksTerry Katz, Director, Global Data Management and Statistics, MeRCK


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 analysesBill 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 outcomesColin 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 successCarol Robertson-Plouch, LRL Strategic R&D Innovations, eLi LiLLy anD COMPany

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 criteriaDeborah Rittenhouse, Senior Manager, Clinical Data Management, CSL BEHRING

12:45 Luncheon

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 trackingMaria 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

datasetsGerson Peltz, Senior Medical Director, Head of Clinical Trial Safety, BIOGEN IdEC


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

completionDr. Lori Post, Associate Professor, Center for Medical Informatics, YALE UNIVERSITY SCHOOL OF MEdICINE

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 collectionTerry Katz, Director, Global Data Management and Statistics, MeRCK

5:00 Conference Co-Chairpersons’ Day One RemarksTerry Katz, Director, Global Data Management and Statistics, MeRCK


5:15 Conclusion of Day One

tuesday, March 17, 2015 Day 2


8:00 Continental Breakfast

9:00 Conference Co-Chairpersons’ Recap of Day OneTerry Katz, Director, Global Data Management and Statistics, MeRCK


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 viewpointCelestine 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 designsPatrick Zbyszewski, Senior Director, Clinical Data Management, ONCONOVA THERAPEUTICS


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 accuracyRaj 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 typeDr. Craig Mallinckrodt, Research Fellow, Strategy and Decision Sciences, eLi LiLLy anD COMPany

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 analysesDr. 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 RemarksTerry Katz, Director, Global Data Management and Statistics, MeRCK


3:30 Conclusion of Conference

CAS

E St

UD

y

“”

“ ”

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

“”

gROuP DisCOunT PROgRaMs:*Offers may not be combined. Early Bird rates do not apply.*

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Phone:866-207-6528

Online:http://exlevents.com/

missingdata/registration

email:[email protected]

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Questions? Comments?Do you have a question or comment you would like to beaddressed at this event? Would you like to get involved as aspeaker or discussion leader?Please email the Program Director, Stephen Grosso, at [email protected] .


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

Five Ways TO RegisTeR Fax: 888-221-6750

Mail: ExL Events, Inc.

494 8th Avenue, 4th Floor

New York, NY 10001

Phone: 866-207-6528

email: [email protected]

Online:

http://exlevents.com/missingdata/registration

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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

Missing Data in Clinical Trials

Discover the most effective strategies to identify, reduce and avoid the pitfalls of incomplete data in your clinical trials.

March 16-17, 2015 • Loews Philadelphia Hotel • Philadelphia, PA

Forum

march 16-17, 2015 • loews philadelphia hotel...

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