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 ...

Biomarkers are redefining how oncology trials are designed, shifting from single-mutation targeting to comprehensive genomic ...

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 ...

Felicione is an independent clinical research scientist and principal investigator. Walk into any drugstore, natural market, or Costco and you’ll find a dazzling array of supplements promising ...

The US Food and Drug Administration (FDA) on Wednesday finalized guidance for sponsors on interacting with the agency on complex innovative trial designs (CID) for drugs and biologics. The nine-page ...

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 ...

With the launch of the National Cancer Institute’s Precision Medicine Initiative in 2015, there has been a shift to trial designs that tailor health care solutions to individual patients by using a ...

Design Therapeutics, Inc. announced the initiation of a Phase 1 clinical trial for its gene-targeted treatment DT-216P2 in healthy volunteers, with patient dosing for Friedreich Ataxia (FA) set to ...