International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials

Brady Keri J. S.; Peipert John Devin; Atkinson Thomas M.Pompili CeciliaPinto MonicaShaw James W.Roydhouse JessicaInt Soc Quality Life Res ClinicalInt Soc Quality Life Res RegulatorTechnol Assessment Engagement SpecInt Soc Quality Life Res Psychomet

首页> 外文期刊>Quality of life research: An international journal of quality of life aspects of treatment, care and rehabilitation >International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials

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International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials

机译：International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials

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In June 2021, the US Food and Drug Administration (FDA) released a draft guidance for industry on core patient-reported outcomes (PROs) and related considerations for instrument selection and trial design in registrational cancer clinical trials, building on prior communications about the use of PROs to assess efficacy and tolerability in oncology drug development. The International Society for Quality of Life Research (ISOQOL) Standards and Best Practices Committee led an initiative to draft a commentary about the guidance, focusing on its positive aspects and areas that would benefit from additional clarification and consideration. For comprehensiveness, the authors reviewed existing public comments on the draft guidance, and the commentary underwent a thorough review process through three ISOQOL Special Interest Groups (Psychometrics, Clinical Practice, and Regulatory and Health Technology Assessment Engagement) followed by the ISOQOL Board. The goal of this commentary is to situate this new and relevant guidance document within the context of recent regulatory efforts on PROs and highlight areas in which further work may ultimately benefit the field.

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《Quality of life research: An international journal of quality of life aspects of treatment, care and rehabilitation》 |2023年第8期|2155-2163|共9页
作者
Brady Keri J. S.; Peipert John Devin; Atkinson Thomas M.Pompili CeciliaPinto MonicaShaw James W.Roydhouse JessicaInt Soc Quality Life Res ClinicalInt Soc Quality Life Res RegulatorTechnol Assessment Engagement SpecInt Soc Quality Life Res Psychomet;
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作者单位

University of Tasmania,Univ Tasmania;

Dept Med Social Sci,Northwestern Univ;

Mem Sloan Kettering Canc CtrPCOR,Univ LeedsBristol Myers SquibbMenzies Inst Med Res,Univ TasmaniaRehabil Med Unit,Ist Nazl Tumori IRCCS Fdn G Pascale;

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原文格式 PDF
正文语种英语
中图分类医药、卫生;
关键词
Patient-reported outcomes; Clinical outcome assessment; Guidance; Oncology; Trial;

International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials

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