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Challenges and Recommendations Related to the Use of ePRO Instruments in Clinical Trials
Program Code:
309
Date:
Wednesday, June 26, 2013
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
J. Jason Lundy, PhD (SCHNON), Assistant Director, Patient-Reported Outcome Consortium, Critical Path Institute, United States
SPEAKER
(S):
Elektra is dermatologist by training has been a medical officer at the FDA since 2001 and with SEALD since 2007. Elektra works in clinical outcome assessment review and qualification and has participated in the development of the FDA PRO guidance as well as the DDT qualification guidance.
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David S. Reasner,
PhD (SPKNON), President and Founder,
Albemarle Scientific Consulting LLC, United States
David Reasner is President and Founder at Albemarle Scientific Consulting LLC which offers management, scientific, and statistical consulting services to a broad array of clients from virtual start-up companies to fully-integrated commercial organizations.
|
Keith W. Wenzel,
(SPKNON), Senior Director, Global Alliances,
Perceptive Informatics, United States
Responsible for advising clinical trial sponsors and consults with regulatory authorities and industry organizations to advance the knowledge of eClinical and patient reported outcomes. A member of the core committee for the DIA’s Study Endpoints SIAC and the DIA Annual Meeting Program Committee.
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Description
Panelists will discuss the rationale for using electronic data capture and provide methodological recommendations for preparing for the use of ePRO instruments in clinical trials. Challenges to the use of ePRO instruments in clinical trials will be discussed, and recommendations for overcoming these challenges will be provided. Real-world examples of the use of ePRO instruments in clinical trials will be used to illustrate the recommendations.