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September 14, 2007 @ 1:00pm – 3:00pm EDT
Designing Adaptive Clinical Trials—Part 2 |
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SPEAKERS FOR THIS EVENT:
- Mark Chang, Director of Biostatistics, Millennium Pharmaceuticals
- Ken Light, Senior Vice President Professional Services, OmniComm Systems, Inc. |
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Improve Trial Design Efficiency
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An adaptive design is a design that allows for modifications to the on-going trial based on either the observed data from the trial or external information. It is recognized that adaptive designs can improve the efficiency of a trial design and increase the probability of success.
During this webinar participants will study different adaptive designs through trial examples including: (1) sample-size re-estimation, (2) drop-loser design, (3) response-adaptive randomization, (4) Biomarker-adaptive design, and (5) adaptive dose-escalation design.
Join Mark Chang from Millennium Pharmaceuticals to get introduced to the concept of adaptive designs; learn how to design adaptive trials; and explore the challenges in the implementations of adaptive designs.
Workshop:
EDC Tools and Integrated Technologies to Support Adaptive Trials
The widespread growth of Electronic Data Capture (EDC) technology is viewed as a fundamental enabler to allow agile trial execution and provide support for early data access, mid-study trial changes, security, traceability and proactive data analysis.o:p>
Ken Light, of OmniComm Systems, Inc will review how the correct implementation of EDC technology, along with integration to other technology enablers, is paramount to achieving and sustaining the adaptive trial paradigm shift that aims to increase the overall effectiveness of clinical trials.
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| THIS PROGRAM IS INTENDED FOR: |
VPs, Directors, Heads, and Managers of:
- Quantitative Clinical Pharmacology
- Strategic Modeling and Simulation
- Statistical Science
- Biostatistics
- Pharmacology Modeling and Simulation
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| SPONSORING PARTNER: |
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OmniComm Systems, Inc. (OTC Bulletin Board: OMCM) is an eClinical software and services company dedicated to helping the world’s pharmaceutical, biotechnology, research and medical device organizations to maximize the value of their clinical research investments through the use of innovative and progressive technologies. We are proud to be focused on customer-driven Internet solutions for those companies that conduct life changing clinical trial research.
Founded in 1998, with a systems integration focus and an EDC solution built for clinical research conducted at Mt. Sinai Hospital, we have continued to develop our product pipeline and services to meet the evolving needs of the drug development marketplace. Electronic data capture and management tools and the clinical trial industry’s use of them continue to evolve and OmniComm remains committed to delivering forward-thinking, customer focused products and solutions.
The heart of OmniComm’s unique product offering begins with TrialMaster®. The Internet-based software, allows clinical trial Sponsors and investigative sites to easily and securely collect, validate, transmit, and analyze clinical study data including patient histories, patient dosing, adverse events and other clinical trial related information. The 21 CFR compliant solution offers unrivaled freedom to conduct clinical trials your way, with unparalleled flexibility, ease-of-use and complete control over your data.
For more information visit http://www.omnicomm.com/ | |
| ABOUT OUR SPEAKERS: |
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Mark Chang, Director of Biostatistics, Millennium Pharmaceuticals
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Dr. Mark Chang has years of experience as a statistician in the field of clinical trials in addition to years of teaching experience. Chang's most recent publications are mainly on adaptive designs and he co-authored the book "Adaptive Design Methods in Clinical Trials" in 2006 and authored the upcoming book “Adaptive Design Theory and Implementation Using SAS and R” (Aug. 2007). As the director of Biostatistics, his involvements in drug development at Millennium include both strategic and methodological aspects. As a technical resource in the biostatistics department at Millennium, he has lead and conducted numerous computer simulations for both classic and adaptive clinical trials and provided quantitative assessments for clinical development programs to assist in decision making. |
Ken Light, Senior Vice President Professional Services, OmniComm Systems, Inc.
Ken Light is the Senior Vice President of Professional Services at OmniComm. Mr. Light is responsible for leading the delivery of technology transfer and implementation services for customers seeking on-site adoption of EDC technology. Prior to joining OmniComm, Mr. Light was a Solutions Partner at BusinessEdge Solutions, Inc. where he oversaw the delivery of technology, strategy and process improvement services for pharmaceutical and life sciences companies seeking to accelerate clinical development. Prior to that he was Practice Director, Life Sciences Consulting for Oracle Corporation where he oversaw clinical software implementation activities for major pharmaceutical and life sciences organizations including Abbott, Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Merck, National Cancer Institute, Schering-Plough, Roche, Pfizer and Wyeth, along with numerous small to mid-size organizations. Before joining Oracle, Ken was Practice Director, Clinical Technology for First Consulting Group where he established Centers of Excellence focused on clinical trial and adverse events IT solutions.
Mr. Light received an M.S., Computer Science from st1:place w:st="on">Fairleigh Dickinson University and has delivered a multitude of educational industry presentations at meetings such as the DIA, EDC and Beyond, ACRP and the Massachusetts Biotechnology Council.
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