Improving Stem Cell Clinical Trial Design and Conduct: Development of a Quality Assessment Tool for Stem Cell Clinical Trials
المؤلفون المشاركون
Qian, Ying
Zhang, Weituo
Li, Yixuan
He, Jinghang
Qian, Biyun
Wang, Jie
Xie, Li
Wu, Zhaohui
المصدر
العدد
المجلد 2020، العدد 2020 (31 ديسمبر/كانون الأول 2020)، ص ص. 1-9، 9ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2020-11-10
دولة النشر
مصر
عدد الصفحات
9
الملخص EN
Background.
Clinical trials are at the cornerstone of evidence-based stem cell therapies, but the quality assessment for designing and conduct these sometimes-complex studies are scarce of evidence.
This study is aimed at developing a handy quality assessment tool for stem cell clinical trials, enhancing capacity of the self-regulate overall quality, and participating protection.
Methods.
The framework of quality assessment tool was based on the PQRS (progress-quality-regulation-scientific) quality assessment tool, and detailed quality indicators were developed by leader group discussion, expert consulting, and literature review.
Stem cell clinical trials were retrieved from the International Clinical Trials Registry Platform, and corresponding quality indicators were assessed and extracted.
The validity and feasibility of conceptual quality assessment tool were further evaluated by using structural equation modeling.
Results.
The quality assessment tool for stem cell clinical trials contains four critical quality attributes, including participant protection, scientific value, quality control, and stem cell products, and 9 observed quality indicators.
From 11 primary clinical trial registries in the International Clinical Trials Registry Platform, 9410 stem cell trial registrations were identified, and 1036 studies were eligible for publications and protocols screening.
After reviewed full text, 37 studies were included in the validity and feasibility evaluation: 32 studies were completed, and 3 studies terminated early.
Most of the studies (83.79%) were in the early phase, and 63.16% of the studies were investigator-initiated trial.
To further tested for validity, the critical quality attributes and quality indicators (QIs) between expertise further validated by the SEM method, which showed a good fit for the model (chi−square=26.008; P=0.353; TLI=0.967; CFI=0.978; RMSEA=0.048).
Compared with exploratory trials, evaluating using the quality assessment tool, confirmatory trials performed similarly in participant protection, scientific value, and quality control, but lower in stem cell products.
Conclusions.
The results of critical quality attributes and quality indicators between expertise and confirmatory validation analysis are basically consistent, indicating the feasibility and validity of applying this quality assessment tool for overall quality evaluation of stem cell trials.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Li, Yixuan& Xie, Li& Wang, Jie& He, Jinghang& Qian, Ying& Zhang, Weituo…[et al.]. 2020. Improving Stem Cell Clinical Trial Design and Conduct: Development of a Quality Assessment Tool for Stem Cell Clinical Trials. Stem Cells International،Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1207944
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Li, Yixuan…[et al.]. Improving Stem Cell Clinical Trial Design and Conduct: Development of a Quality Assessment Tool for Stem Cell Clinical Trials. Stem Cells International No. 2020 (2020), pp.1-9.
https://search.emarefa.net/detail/BIM-1207944
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Li, Yixuan& Xie, Li& Wang, Jie& He, Jinghang& Qian, Ying& Zhang, Weituo…[et al.]. Improving Stem Cell Clinical Trial Design and Conduct: Development of a Quality Assessment Tool for Stem Cell Clinical Trials. Stem Cells International. 2020. Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1207944
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1207944
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر