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The design, enrollment criteria, tissue acquisition protocols, and determination of gene expression values for patients enrolled in the MIMS trial are described in more detail in a separate publication [ 33].
Patient-centered approaches may also be important to ensure adequate intervention design, enrollment, retention, and evaluation of outcomes important to children and their families.
These clinical insights suggest that simulation might offer similar improvements in the design, enrollment, and execution of complex phase 3 clinical research trials.
This article highlights current questions in clinical trial design, enrollment strategies and patient focused drug development, with particular emphasis on unique issues in trials of targeted therapy and immunotherapy.
Study design, enrollment, and collection of data and biospecimens have been described in detail previously [ 23].
ZO participated in the study design, enrollment of subjects and performed the biological exams.
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The REMARK guidelines, consisting of 20 detailed items, assess several aspects of the enrolled studies, such as study aim, study design, patient enrollment, biomarker detection, statistical analysis method, and report of results.
In this design, patient enrollment does not need to stop when transitioning from the evaluation of the dose safety and tolerability to the assessment of its efficacy.
This paper describes the rationale, design, participant enrollment, and implementation of a 3-arm randomized, parallel-group clinical trial comparing LAUNCH to a motivational-interviewing intervention (MI) and standard care (STC), respectively.
In 2012, a group of experts met to review recent experience with case-control studies evaluating the effectiveness of several vaccines; here we summarize the recommendations of that group regarding best practices for planning, design and enrollment of cases and controls.
The study design and enrollment are shown in Supplementary Fig. 1.
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