Thursday, March 12, 2008
APPLICATION OF OTHER ELECTRONIC SYSTEMS IN CLINICAL TRIALS
8:30 am Chairperson’s Opening Remarks
8:40 Web Based Endpoint Adjudication; Overcoming Geographical and Language Barriers in Local and Global Morbidity/Mortality Studies
Drew Kilpatrick, Ph.D, Director, Global Safety and Pharmacovigilance, Kendle
Remote electronic adjudication offers an alternative to paper based adjudications of clinical endpoints arising in regulatory morbidity/mortality studies or in post-registration safety studies. Independent experts making the adjudication have access from their home or office to all available patient documents (physician reports/discharge summaries etc) and images (CT/MRI/ECG) via the internet. Linking the adjudication system to a Web-based portal allows integration of translation services as part of the adjudication “package”. Geography and language are no longer barriers to clinical endpoint adjudication alleviating the need for face-to-face meetings.
9:10 Case Study - Use of IVRS in the Assessment of Patient Compliance and Collection of Primary Endpoints
Bruce Bailey, Senior Director IVRS, Premier Research
The presentation will discuss the collection of subject diary data via an IVRS Diary System (ePRO). The presentation will focus on the actual imple-mentation in a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III, Efficacy & Safety Study in Patients with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee. In this trial, the IVRS (ePRO) was used for the capture of primary and secondary efficacy data. The system was also used to calculate the baseline pain intensity scores, the tracking of subject diary entry compliance percentages and used this information to determine eligibility criteria. The discussion will provide an overview of the system design, data collection process, implementation, data transfer process, and data reconciliation process.
9:40 Critical Features of Data Collection & Incorporation for Adaptive Design Trials Sponsored by 
Richard Young, B.Sc (Hon), Director, Business Development, Cmed Research
10:10 Networking Coffee Break
10:40 CDASH Initiative and CDISC Standardization Projects
Frank Newby, COO, CDISC
The CDASH initiative is an FDA Critical Path Opportunity that seeks to enable standardized collection of clinical research data at investigative sites. Through standardization of basic data collection, efficiencies can be achieved that will result in less confusion across sponsors and investigators as well as facilitate more efficient monitoring, audit, submission and review procedures. An update relative to the progress made on this initiative will be discussed.
11:10 FDA’s Perspective on the Use of Electronic Systems in Clinical Trials
Leonard Sacks, M.D., Deputy Director of FDA’s Office of Critical Path
| PANEL |
11:40 Panel with Speakers - Regulatory Issues Associated with Electronic Systems
Moderator: Leonard Sacks, M.D., Deputy Director of FDA's Office of Critical PathPanel Members:
• Jonathan Helfgott, Consumer Safety Officer, FDA, Center of Devices and
Radiological Health, Division of Bioresearch Monitoring
• Frank Newby, Chief Operating Officer, CDISC
• Burke T. Barrett, M.B.A., Vice President, Regulatory and Clinical Affairs, Cardio Focus
Discussion Topics:
- System validation
- Part 11 compliance
- Original source documentation
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12:10 pm Close of Conference