Clinical trialExternal control armDecentralized clinical trialsReal-world dataReal-world evidenceRecord linkagePatient diversityConducting clinical trials (CTs) has become increasingly costly and complex in terms of designing and operationalizing. These challenges exist in running CTs on novel therapies, ...
For clinical trial simulation, the median of overall knowledge score increased from 2.11 to 4.00 with a pre-post correlation of 0.35 (P = 0.002) and a change of 1.60 (95% CI, 1.48, 1.80, P < 0.001), seen in Fig. 2A. When comparing with external control, both pre-interventio...
The FDA expects sponsors to have a finalized protocol before initiating an external control trial.The FDA is looking to dissuade sponsors from adding the external controls after the completion of a single-arm trial, and instead, proposes upfront planning to allow inclusion of the ...
For the assessment of clinical effectiveness, the preventive study included 67 patients, of which 34 were in the intervention group (IG) and 33 in the control group (CG) [15]. Of the 67 patients, 91% were women and eight (11.9%) patients were lost to follow-up. The acute treatment st...
Clinical and experimental research has converged to indicate the fractionation of frontal subprocesses and the initial mapping of these subprocesses to discrete frontal regions (Stuss & Levine, 2002). Factor analysis has also supported that executive functions include several subcomponents (Mantyla, ...
For this, the development, functions, interactions with the microenvironment, and clinical importance of B cells should be well understood. In this review, we summarize the main events during B cell activation. From the viewpoint of mechanobiology we discuss the translation of external cues such ...
OBJECTIVES :We examined the impact of brachytherapy boost (BB) and external beam radiotherapy (EBRT) dose-escalation on overall survival (OS) for women wit... BJ Ager,A Torgeson,SR Francis,... - 《American Journal of Clinical Oncology》 被引量: 0发表: 2019年 加载更多来源...
In this randomized, double-blind, placebo-controlled trial, women with a singleton fetus in breech presentation and a gestational age of 36 weeks or more were eligible for enrollment. Participating women received two doses of either nifedipine 10 mg or placebo, 30 and 15 minutes before the ...
There is a growing interest to the use of externally derived real-world data as a proxy for control group to aid in interpreting the findings from single arm trial. In the case of Maziarz et al., the investigators had access to the IPD of both JULIET and historical control arm, enabling...
Prediction models and prognostic scores have been increasingly popular in both clinical practice and clinical research settings, for example to aid in risk-based decision making or control for confounding. In many medical fields, a large number of prognostic scores are available, but practitioners may...