EPro : Electronic Solutions for Patient-Reported Data

EPro : Electronic Solutions for Patient-Reported Data

Author
Brian TipladyBill Byrom
Publisher
Taylor & Francis Group
Language
English
Edition
1
Year
2010
Page
294
ISBN
9781409412427,9780566087714
File Type
pdf
File Size
7.5 MiB

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. Bill Byrom and Brian Tiplady's ePro addresses these questions, reviews the new FDA guidance, and provides a very contemporary view on this important subject.

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