As compared to conventional, stand-alone clinical trials in advanced non-small cell lung cancer (NSCLC), the biomarker-driven Lung Cancer Master Protocol (Lung-MAP) has enrolled higher percentages of ...
Clonal Hematopoiesis as a Molecular Risk Factor for Doxorubicin-Induced Cardiotoxicity: A Proof-of-Concept Study Lung Cancer Master Protocol (Lung-MAP), a public-private partnership, established ...
Biomarker-driven master protocols represent a new paradigm in oncology clinical trials, but their complex designs and wide-ranging genomic results returned can be difficult to communicate to ...
The US Food and Drug Administration (FDA) on Friday unveiled two draft guidances focused on adaptive clinical trial designs and master protocols for cancer treatment trials. The 32-page adaptive ...
The open-access paper, titled ‘An Overview of Precision Oncology Basket and Umbrella Trials for Clinicians,’ provides a valuable resource for increasing master protocol trial literacy among the many ...
Business as usual has not been the mantra for companies developing Covid-19 vaccines and drugs. Instead, biopharma companies and their partners pursued various transformational approaches to get ...
Adaptive clinical trial design represents a modern approach to evaluating healthcare interventions that allows pre‐specified modifications based on accumulating data. This flexible methodology ...
Developing treatments for rare diseases poses many unique challenges that cannot be addressed by traditional study designs. Small populations will result in prolonged enrolment periods and/or ...
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