Emulation, simulation, and synthesis represent distinct synthetic-patient paradigms, ranging from reweighted external controls to mechanistic/statistical disease ...
Health care is undergoing an important and well-needed shift from a one-size-fits-all approach to more personalized, precise, patient-focused care. A similar approach needs to be implemented at scale ...
In oncology drug development, using biomarkers to select a study population more likely to benefit from a therapeutic effect is critical to increase the efficiency of a clinical trial in demonstrating ...
Successful clinical trial conduct balances participant safety, treatment efficacy and operational feasibility. But slow patient identification and enrollment, cost overruns and missed deadlines pose a ...
Written agreement from FDA for single-arm, open-label, baseline-controlled registrational trial evaluating composite primary endpoint of improvement in CGI-I and gain of developmental milestone/skill ...
Diffuse cutaneous systemic sclerosis (“dcSSc”) is a rare, progressive autoimmune disease characterized by immune activation, vasculopathy and fibrosis affecting the skin and internal organs, including ...
Creating a Proxy for Baseline Eastern Cooperative Oncology Group Performance Status in Electronic Health Records for Comparative Effectiveness Research in Advanced Non–Small Cell Lung Cancer ...
Modifying Clinical Trial Designs to Test Treatments for Clinical Significance in Individual Patients
The aim of this article was to design clinical trials that test treatments for clinical significance in individual patients. In a repeated measures design a scalar summary statistic describes the ...
Digital patient profiles and real-world data enhance oncology trial design, patient recruitment, and reduce trial failure risks. Phesi's platform aligns trial designs with real-world data, minimizing ...
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