The US Food and Drug Administration (FDA) has released guidance about innovative trial designs for cell and gene therapy (CGT ...

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 ...

High-quality evidence is what we use to guide medical practice. The standard approach to generating this evidence — a series of clinical trials, each investigating one or two interventions in a single ...

Rather than mounting separate trials, an important paradigm shift to expedite clinical development is to establish the so-called master protocol or platform trial—a program of trial development and ...

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 ...

Adaptive clinical trial design represents a modern approach to evaluating healthcare interventions that allows pre‐specified modifications based on accumulating data. This flexible methodology ...

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 ...