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• W2945139022 endingPage "387" @default.
• W2945139022 startingPage "374" @default.
• W2945139022 abstract "Historically, patient experience, including symptomatic toxicities, physical function, and disease-related symptoms during treatment or their perspectives on clinical trials, has played a secondary role in cancer drug development. Regulatory criteria for drug approval require that drugs are safe and effective, and almost all drug approvals have been based only on efficacy endpoints rather than on quality-of-life (QoL) assessments. In contrast to Europe, information regarding the impact of drugs on patients’ QoL is rarely included in oncology drug labeling in the United States. Until recently, patient input and preferences have not been incorporated into the design and conduct of clinical trials. In recent years, a more in-depth understanding of cancer biology, as well as regulatory changes focused on expediting cancer drug development and approval, has allowed earlier access to novel therapeutic agents. Understanding the implications of these expedited programs is important for oncologists and patients, given the rapid expansion of these programs. In this article, we provide an overview of the role of QoL in the regulatory drug–approval process, key issues regarding trial participation from the patient perspective, and the implications of key expedited approval programs that are increasingly being used by regulatory bodies for cancer care." @default.
• W2945139022 created "2019-05-29" @default.
• W2945139022 creator A5022163984 @default.
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• W2945139022 creator A5064836775 @default.
• W2945139022 creator A5089899558 @default.
• W2945139022 date "2019-05-01" @default.
• W2945139022 modified "2023-09-24" @default.
• W2945139022 title "Patient-Centered Cancer Drug Development: Clinical Trials, Regulatory Approval, and Value Assessment" @default.
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• W2945139022 doi "https://doi.org/10.1200/edbk_242229" @default.
• W2945139022 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/31099613" @default.
• W2945139022 hasPublicationYear "2019" @default.
• W2945139022 type Work @default.
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