The US Food and Drug Administration (FDA) recently highlighted three case studies showing how sponsors can incorporate innovative study designs in their clinical trials using the agency’s Complex ...
Join the RAPS Twin Cities Chapter for an engaging and practical session focused on understanding clinical study design and statistics as they apply to medical device regulatory strategy. This session ...
SAN DIEGO, CA—Does the use of a primary composite endpoint help or harm when it comes to interpreting modern-day clinical trials? Do softer clinical endpoints, such as recurrent angina, restenosis, or ...
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Mastering study designs for better health research
Understanding epidemiological and clinical study designs is key to producing reliable health evidence. From descriptive reports to randomized trials, each design has unique strengths and limitations.
Clinical trials are well-controlled and designed experiments that aim to prove that an Investigational Medicinal Product (IMP) is effective. Clinical trial data is submitted to the national health ...
As biomarker studies employ increasingly complex and expensive genomics and other correlative methods, it is increasingly important to rigorously design these studies and analyze the downstream ...
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