Clinical Research

To win the fight against COVID-19, there is an urgent need for studies to develop vaccines, drugs, devices and reused drugs. Randomized clinical trials will be used to provide evidence of...

"Conflicts aren't always bad," says Dr. Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, Manager of Kelly Willenberg & Associates. She is a big advocate of what she calls “conflict literacy,” or...

The US Food and Drug Administration has just published a call for applications for the next cohort of the Patient Engagement Collaborative (PEC). Founded in 2018 in collaboration with the Clinical...

Researchers are using computer models to simulate COVID-19 infections at the cellular level - the fundamental structural level of the human body. The models enable virtual studies of drugs and vaccines...

Developing new formulations and therapeutic targets for approved drugs can help treat cancer and other diseases. This is the concept behind the South Dakota State University-run Center for Drug, Disease and...

If we as an industry learn from fighting the COVID-19 pandemic, David Burrow, PharmD, JD, Director of the Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research...

An Effective Corrective and Preventive Action Plan (CAPA) for practitioners in clinical trials focuses like a laser on the root cause of a protocol deviation by adamantly asking, "Why did something...

US Food and Drug Administration (FDA) regulators "like to see a focus on Corrective and Preventive Action" (CAPA) after submitting a Form 483 to a study center manager or manager at...

Scientists at St. Jude Children's Research Hospital have proposed a new method for designing phase II clinical trials and developed software to implement the approach. The work was recently described in...

Letter in the July 12 online edition of Nature communication, Researchers at the University of California's San Diego School of Medicine (UC) describe a new approach that uses machine learning to...