A new U.S. Food and Drug Administration (FDA) guidance is designed to help practitioners conduct clinical trials that often feature relatively delicate young patient populations struggling with attention deficit hyperactivity […]
Clinical trial professionals are muddling through when it comes to grappling with technology day-to-day on the job, with about one-third of those responding to an in-depth survey saying the systems […]
A new draft guidance from the Food and Drug Administration (FDA) beefs up some of the recommendations in the International Council for Harmonization (ICH) E9 Statistical Principle for Clinical Trials […]
Clinical Researcher—April 2019 (Volume 33, Issue 4) PEER REVIEWED Geoffrey Gill, MS Drug development costs today have spiraled out of control. A report from Tufts in 2016{1} estimated the cost […]
Clinical Researcher—April 2019 (Volume 33, Issue 4) PEER REVIEWED The U.S. Food and Drug Administration’s (FDA’s) Form FDA 1572 is one of the many important regulatory documents submitted to the […]