This chapter introduces the concepts of phase I, II, and III clinical trials. The overall design of any clinical trial can be represented by a flow chart called the schema. This chapter provides a guided tour of a dozen different schema, ranging from simple to progressively more complex.Tom ...
The section on roles and responsibilities focuses on people responsible for delivering the qualitative element of trials and putting the SOP into practice, namely the CI, TQR, QL, trial manager/coordinator, and trial data manager. The section on procedures begins with a flow chart of qualitative ...
In other words, the clinical trials that do not meet these criteria were excluded. Fig. 1 presents the flow chart in details. Download: Download high-res image (193KB) Download: Download full-size image Fig. 1. The flow-chart summary of the searching process. CiteSpace software (Version ...
a meta-analysis of prospective comparative clinical trials (including 4 randomized controlled trials and 4 cohorts) was conducted. The defocus curves showed a better distance-corrected intermediate visual acuity (VA) for the trifocal group (MD −0.07; 95% CI, −0.10 ...
Versionnumber1.1 Projectname: ArthroscopicAssistedBalloonTibioplastyfortheTreatmentofSchatzkerII-IV TibialPlateauFractures Clinicaltrialprotocol Projectnumber:SAHoWMU-CR2017-08-105 ClinicalTrials.govIdentifier:NCT03327337 Versionnumber:1.1 Versiondate:2017.09.01 ...
There has been some eSource-related research progress in the field of clinical trials [2,3,4] and in relatively large projects, such as the OneSource project, EHR4CR project, European FP7 TRANSFoRm project, etc. [5,6,7]. However, the characteristics of real-world studies (RWSs) requires...
Drug Administration for the treatment of the common cold. A number of clinical trials have been conducted and published. However, there is no systematic review or meta-analysis on their efficacy and safety for the common cold to justify their clinical use. ...
Cluster trials in implementation research: estimation of intracluster correlation coefficients and sample size. Stat Med. 2001;20:391–9. Article CAS PubMed Google Scholar Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care. 1989;27:S178–89. ...
(ClinicalTrials.gov number: NCT00673491) was to determine whether CPs can improve quality of care. The main objective was to determine whether CPs are more effective than usual care in treating patients with stroke, and whether CPs reduce both patient mortality and improve patient outcomes. The ...
the findings of molecular testing may inform clinical expectations of disease progression according to the pathogenicity of the mutation and knowledge regarding the correlation of genotype with phenotype [30]. Molecular testing results may also impact the patient’s eligibility for clinical trials and fu...