Compliance In Focus

In our recent blog , we discussed the backlog of clinical trial submissions the FDA now faces, which was caused by the temporary government shutdown.  The articles cited in that blog focused on the impact of new FDA submissions, and particularly on the detrimental effects to start-up companies.  However, how have ongoing clinical trials been affected during this time period?  More importantly, how have the lives of the patients on the other side of that experimental drug or device been affected?

According to the National Institute of Health (NIH), nearly 3,500 people participate in the Clinical Research Healthy Volunteer Program (CHVP). The program, started in 1954, provides an opportunity for healthy volunteers, locally, nationally, even internationally, to participate in medical research studies to provide researchers with important information for comparison with people who have specific illnesses.