The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency ...

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 ...

Lung Cancer Master Protocol (Lung-MAP), a public-private partnership, established infrastructure for conducting a biomarker-driven master protocol in molecularly targeted therapies. We compared ...

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) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent ...

Clinical trials are evolving. Traditional study designs, testing one drug in one disease, can be slow and resource intensive. In fields like oncology or rare diseases, where efficiency and flexibility ...

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 ...

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 ...

The global Covid-19 pandemic has left families and communities around the globe grieving for lost loved ones, exhausted from prolonged social isolation, and anxious about their financial future as ...

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