FDA Guidance on Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments: Old Wine in a New Bottle?

IF 3.4 3区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Patient-Patient Centered Outcomes Research Pub Date : 2023-01-01 DOI:10.1007/s40271-022-00607-6

Ari Gnanasakthy, Shanshan Qin, Lindsey Norcross

引用次数: 1

查看原文本刊更多论文

FDA关于选择、发展或修改符合目的临床结果评估的指南:新瓶装旧酒?

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Patient-Patient Centered Outcomes Research HEALTH CARE SCIENCES & SERVICES-

CiteScore

6.60

自引率

8.30%

发文量

审稿时长

>12 weeks

期刊介绍： The Patient provides a venue for scientifically rigorous, timely, and relevant research to promote the development, evaluation and implementation of therapies, technologies, and innovations that will enhance the patient experience. It is an international forum for research that advances and/or applies qualitative or quantitative methods to promote the generation, synthesis, or interpretation of evidence. The journal has specific interest in receiving original research, reviews and commentaries related to qualitative and mixed methods research, stated-preference methods, patient reported outcomes, and shared decision making. Advances in regulatory science, patient-focused drug development, patient-centered benefit-risk and health technology assessment will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in The Patient may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances. All manuscripts are subject to peer review by international experts.