Dear colleagues,
As statisticians we should all take an interest in how data are collected
and increasingly patient outcome (ePRO) data are being collected over the
phone or web. How are such data collected and validated may be of interest
to some of you
Please find details below of two free webinars on innovative ePRO trials.
Mon 12th Dec 2005: 3:00 pm UK time (10:00 am US East Coast time)
Tue 13th Dec 2005: 7:00 pm UK time (2:00 pm US East Coast time)
Our educational webinars are free, non-commercial and interactive. If
interested please register at the link below and there is no need to reply
direct to me.
www.clinphone.com/webinars
Further details can be found below or by following the link.
KR
Malcolm Morrissey
Statistician
Clinphone Group Ltd
www.clinphone.com
ePro: Innovative ePro Trials and the FDA: The Age of Electronic Patient
Diaries
In this era of innovation, there is a plethora of electronic collection
methods for Patient Reported Outcomes (PRO) including IVR, hand-held
devices, the World Wide Web and others. Well documented is the fact that
electronic collection of PRO data results in much improved data integrity,
assured timelines of PRO data records; superior, cleaner data requiring less
data management when compared to paper.
The FDA has recently approved several drugs on the strength of
patient-reported outcomes collected electronically. The agency has also
stated that they would accept electronic versions of several specific
clinical assessments as primary efficacy endpoints in trials. What are the
latest regulatory considerations that face sponsors using ePRO?
Technologies also offer new opportunities to collect onset of action data
and new methods to orient study subjects and elicit data from them. Dr. John
Greist of HealthCare Technology Systems will discuss new assessments and the
associated validation methods used.
While emerging technologies offer significant benefits, they also present
new challenges. This webinar will review these key issues and will present
case studies to illustrate how sponsors and vendors are addressing them.
At the conclusion of this webinar, attendees will understand:
Regulatory considerations in the use of ePRO
Models for use for ePRO systems
Newly developed ePRO assessments and data collection methods and the
associated validation data
Full agenda and registration details can be found at
www.clinphone.com/webinars
Mon 12th Dec 2005: 3:00 pm UK time (10:00 am US East Coast time)
Tue 13th Dec 2005: 7:00 pm UK time (2:00 pm US East Coast time)
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