Abstract：
INTRODUCTION:The increasing complexities of conducting multiregional trials and an evolving regulatory environment contribute to unprecedented new challenges for use of patient-reported outcome measures (PROMs)(1) within clinical trials. This paper presents these challenges and potential solutions. METHODS:Real-world examples and situations are reviewed from an industry and patient-reported outcome (PRO)(2) expert position. CONCLUSIONS:An increase in the pursuit of new therapeutic targets, changes to the regulatory environment, and business pressures to expand clinical trials to more countries have significantly increased the complexity of confirmatory clinical studies that incorporate PROMs. Decisions to participate in collaborative efforts for endpoint development or proceed independently are made in the context of competing priorities of drug development timelines, drug differentiation strategies, the need for patient-related value messages, and the depth of a sponsor pipeline within specific disease areas. Study logistics are critically important; factors such as concept cultural relevancy, respondent literacy level, and quality of cross-cultural adaptation of PROMs must be evaluated when integrating into confirmatory clinical trials. Awareness of the issues relating to PROs in multiregional studies will enable companies to better plan studies and interpret results.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Gnanasakthy A,DeMuro C,Boulton Cdoi
10.1016/j.cct.2013.02.006subject
Has Abstractpub_date
2013-05-01 00:00:00pages
62-9issue
1eissn
1551-7144issn
1559-2030pii
S1551-7144(13)00014-1journal_volume
35pub_type
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journal_title：Contemporary clinical trials
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pub_type： 杂志文章,多中心研究,随机对照试验
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pub_type： 杂志文章,多中心研究,随机对照试验
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