A new draft guidance from the Food and Drug Administration (FDA) beefs up some of the recommendations in the International Council for Harmonization (ICH) E9 Statistical Principle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 […]
Clinical Researcher—April 2019 (Volume 33, Issue 4) CLIN OPS INSIGHTS Priti Sahai, MBBS, MS The clinical research protocol is the blueprint that determines a study’s downstream activities, and it has […]
Clinical Researcher—April 2019 (Volume 33, Issue 4) PI CORNER Elizabeth Weeks-Rowe, LVN, CCRA There are fundamental steps a physician who is interested in conducting clinical research can take to best […]