Clinical Researcher—May 2019 (Volume 33, Issue 5) EXECUTIVE DIRECTOR’S MESSAGE Jim Kremidas Two hundred and fifty years ago, when the British empire ruled the Atlantic Ocean, Scottish physician James Lind was tasked with finding out why scurvy was killing more sailors than Spanish and French enemies. Like a few others, he had a theory that […]
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 of introducing a new drug at $2.6 billion. On the other side, a 2018 report from Deloitte{2} estimated that the return on investment for new […]
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 agency in connection with clinical trials. Many common mistakes are made when filling out and maintaining the 1572 form, so the hope is that this […]
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 an impact on all stages of the study—from design and planning to analysis and submission. The protocol describes the rationale for the research and how […]
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 prepare for his or her new role as a principal investigator (PI). These tasks are integral to understanding such research tenets as patient safety, critical […]
