India, April 29 -- In what is said to be a "bold modernization of clinical research," the U.S. FDA has taken two major steps toward implementing real-time clinical trials- an approach that could allow regulators to view safety signals and key endpoints as they happen.
Early-phase clinical trials are often slowed by fragmented data reporting, limited patient populations, and long delays between data collection and FDA review. Traditionally, trial sites send data to sponsors, who analyze and later submit findings to the agency- a process that can take months or even years. The FDA has now launched two proof-of-concept real-time clinical trials (RTCTs) with AstraZeneca and Amgen.
AstraZeneca's Phase 2 TRAVERSE study in treatment-naive mantle...