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Stockreport

FDA Announces Major Steps to Implement Real-Time Clinical Trials [Yahoo! Finance]

Amgen Inc. (AMGN)  More Company Research Source: Yahoo! Finance
Last amgen inc. earnings: 4/30 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: investors.amgen.com
Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT). First, the agency unveiled the successful initiation of two proof-of-concept clinical trials that will report endpoints and data signals to the agency in real time. Second, the agency released a Request for Information (RFI) regarding a proposed pilot program for RTCT that will launch this summer. Early-phase clinical trials are a bottleneck in drug development, often characterized by high uncertainty, limited patient populations, and inefficient decision-making processes. Data is typically reported from sites to sponsors, who analyze and subsequently submit data to the FDA. With improvements in AI and data science, sponsors and trial sites have the opportunity to conduct real-time trials in a way that enhances safety monitoring and radically increases efficiency. “For 60 years, we've been conducting clinical trials in the same wa [Read more]
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Stockreport

FDA Announces Major Steps to Implement Real-Time Clinical Trials [Yahoo! Finance]

Amgen Inc.  (AMGN) 
More Company Research Source: Yahoo! Finance
Last amgen inc. earnings: 4/30 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: investors.amgen.com
Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT). First, the agency unveiled the successful initiation of two proof-of-concept clinical trials that will report endpoints and data signals to the agency in real time. Second, the agency released a Request for Information (RFI) regarding a proposed pilot program for RTCT that will launch this summer. Early-phase clinical trials are a bottleneck in drug development, often characterized by high uncertainty, limited patient populations, and inefficient decision-making processes. Data is typically reported from sites to sponsors, who analyze and subsequently submit data to the FDA. With improvements in AI and data science, sponsors and trial sites have the opportunity to conduct real-time trials in a way that enhances safety monitoring and radically increases efficiency. “For 60 years, we've been conducting clinical trials in the same wa [Read more]
IMPACT SNAPSHOT
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AMGN
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Multi-day stock performance from the time of the news release
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