Informed consent errors have fallen to sixth from first place as cited in most common clinical investigator findings by the U.S. Food and Drug Administration (FDA) over the past five years. While that suggests clinical researchers and sites have gotten better at handling this critically important set of tasks, it may not tell the whole […]
Ensuring individuals are able to make an informed decision when deciding whether or not to enroll in a research study is a cornerstone of conducting ethical research. How do we ensure that the consent is valid, and that the signature on the document represents a truly informed study participant? This article addresses the rational for […]
While clinical research is often ethically challenging, clinical trials in oncology can bring uniquely difficult ethical considerations. Researchers and study teams have long struggled with the difficulties of conducting research and obtaining truly informed consent in patients who may be driven by understandable, but irrational, desperation for an intervention that has promise to be a […]
Let’s face it: clinical research coordinators (CRCs) can make or break any trial. Beginning with the site selection visit, the coordinator is carrying a large load. Tasked to learn new trial procedures, vendors, and schedules, they must also explain these details to patients and their team. Tight timelines and pressure from all sides wreak havoc […]
As we head into 2016, clearly there are some significant issues and changes pending and under review regarding the conduct of clinical research following the tenets of good clinical practice. As we begin another year and not too many questions have been coming in to answer in the usual Q&A format of this column, I […]
