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 […]
Comments submitted regarding Scientific guidance on post-authorisation efficacy studies. (Identifier: EMA/PDCO/CAT/CMDh/PRAC/CHMP/261500/2015). Click here to read the comments and impact on ACRP Members.
Assessing risk in advance is the key to running a safe, successful clinical trial, says Peggy Fay, PhD, RN, CCRC, a clinical research consultant with Clinical Research Facilitators in Buford, Ga. The stakes are high. She recently worked on a trial where the sponsor and team did everything right—except consider the possibility the product wouldn't […]