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Books > Business & Economics > Economics
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ePro - Electronic Solutions for Patient-Reported Data (Hardcover, New Ed)
Loot Price: R4,582
Discovery Miles 45 820
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ePro - Electronic Solutions for Patient-Reported Data (Hardcover, New Ed)
Expected to ship within 12 - 17 working days
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Patient self-reported data has become increasingly important in
today's clinical trials. Trials in some disease indications rely
upon patient recorded diary data as the primary endpoint to
demonstrate drug efficacy - including, for example, indications
such as insomnia, migraine and pain. In addition, improvements in
quality of life measured using patient questionnaires can now be
included as claims on drug labelling. Traditionally these data have
been collected using paper questionnaires and diaries issued to
subjects. Regulators and the industry have become increasingly
aware of the limitations of recording patient reported outcomes
data on paper including data quality and integrity issues. As a
result there is a growing interest in collection of patient
reported outcomes data using electronic means (ePRO). Solutions
include handheld PDAs, Interactive Voice Response (IVR) systems,
and other site-based hardware such as touchscreen PCs. Recently,
there has been much open debate with the regulators around the use
of ePRO in clinical drug submissions. US and European agencies have
approved new drugs that have included ePRO data in the submission
dossier, but there are many questions around the adoption of the
technology that concern the community. These include: c How should
instruments developed on paper be adapted for electronic use, and
what degree of validation should be done between paper and
electronic forms? c How can researchers ensure they are complying
with regulatory requirements including the PRO guidance published
by FDA in 2009 when using ePRO solutions? c Can fewer patients be
exposed in a clinical trial as a result of improved data quality
obtained using electronic diaries? c What type of solution should
be used for certain patient populations and protocols, and how can
ePRO solutions be designed optimally to increase patient
acceptability and compliance? Bill Byrom and Brian Tiplady's ePro
addresses all these issues, reviews the new FDA guidance, and
provides a very contemporary view on this important subject.
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