Single-Arm Studies Can Have Adaptive Designs, Industry Tells FDAVibha Sharma
摘要: Appendix B Excluded Studies; Appendix C Summary Tables and Figures; Appendix DComparative Studies: Full Evidence/Data Abstraction Tables; Appendix E Single-Arm Studies.Disable Glossary Links < PrevNext >. Samson DJ, Ratko TA, Rothenberg BM, et al....
The analysis of 17 studies included in this study suggests that PDT may be effective in achieving complete response (CR) [ES = 0.50, 95%CI: (0.33,0.66)], partial response (PR) [ES = 0.42, 95%CI: (0.27,0.56)], no response (NR) [ES = 0.19, 95%CI: (0.11,0.27)]...
Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice. Lancet Oncol. 2023;24(5):e197–206. Article PubMed Google Scholar Pe M, Alanya A, Falk RS, Amdal CD, Bjordal K, Chang J, et al. Setting International Standards in Analyzing ...
We did not calculate the sample size due to the nature of single-arm studies. To balance significant differences in baseline characteristics between the RUX group and the HC group, PSM was used to mitigate potential confounding factors (Additional file1: Table S2). Propensity scores were ...
24 Based on literature reports and animal experimental results, considering that the side effects of MSC infusion are mainly related to the single injection dose, the second stage mainly studies safety of different doses. Also, to compare efficacy, the total number of cells received by each ...
BackgroundInjectable poly-L-lactic acid (PLLA) is a synthetic polymer indicated for the correction of facial wrinkles and folds. Animal studies have shown that implantation of PLLA stimulates collagen synthesis; human studies have been limited. ObjectiveTo investigate human tissue response to injectable...
Safety and Efficacy of Low Molecular Weight Heparins in Children: A Systematic Review of the Literature and Meta-Analysis of Single-Arm Studies. et al: Safety and efficacy of low molecular weight heparins in children: A systematic review of the liter- ature and meta-analysis of single-arm st...
We would like to thank all of the patients, and the investigators and their teams, who participated in these studies. We also thank Biotrial (Rennes, France), which provided logistical support for this study, and Varinia Munoz, PhD, from Complete Medical Communications, who provided medical wr...
External comparator studies can vary in approach, not only by type of data source but also by method of the comparison. We analyzed whether companies where using a simple, non-statistically adjusted (or ‘naïve’) comparison approach or if statistical adjustment methods were used (either direct...