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 ...

Emulation, simulation, and synthesis represent distinct synthetic-patient paradigms, ranging from reweighted external controls to mechanistic/statistical disease ...

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 ...

Note: This is the third article of a three-part series. Real-world evidence (RWE) plays a crucial role in supporting the benefits of one drug over another in debates that play out on the boards and ...

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 ...

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 ...

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 ...

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 ...