27 Mar US FDA releases draft guidance for cancer clinical trials
The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving oncology clinical trials for accelerated approval....
The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving oncology clinical trials for accelerated approval....
The FDA approved leniolisib as the first treatment indicated for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare genetic disorder that causes progressive primary immunodeficiency....
While increased awareness of disparities has improved our understanding of differences in health outcomes related to race, ethnicity, language, and other demographic factors, there remains limited reduction in healthcare disparities....
The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year....
The U.S. health regulator on Friday proposed cancer drug developers in most cases conduct more rigorous trials to seek accelerated approval for their candidates....
Generating evidence by integrating research into patient care....
Many changes were made to the FDA's requirements for clinical research during the pandemic, including adoption of decentralized clinical trial elements. How will this affect future inspections....
A doctor who leads clinical trials explains the goals of this type of research and what questions you should ask before joining....
Researchers discovered race/ethnicity underrepresentation during an analysis of over 100 dermatology-focused clinical trials....
In addition to an expanding role as participants in trials, women are leaders at stakeholder organizations, skilled clinical research professionals, and passionate advocates for female representation in clinical research....