Andrew Smith | Authors

Articles

Unique Immunotherapy Combinations Provide an Optimistic Outlook in Early Urothelial Carcinoma Trials

March 11, 2019

Ongoing research seeks to boost objective response rates in urothelial cancer by developing biomarkers to predict which immune checkpoint inhibitors a patient is most likely to respond to and by testing these in combination with each other and other treatment types to increase both the number and duration of responses.

Expansion Cohorts Guidance Balances Drug Development With Safety, Rigor

December 26, 2018

New draft guidelines from the FDA endorse the use of multiple expansion cohorts in first-in-human clinical trials as a means of speeding lifesaving medications to market, but the document warns that the difficulties and dangers of using such complex studies so early in the testing process necessitate unusually careful design and oversight.

Trial Investigators Discuss FDA Draft Guidance on Master Protocols

December 01, 2018

Complex drug trials that use a single protocol to test either 1 agent against multiple cancers or multiple agents against 1 cancer can make drug testing faster, cheaper, and more informative, particularly when those trials use the data to constantly improve protocols.