American early-phase CRO Clinilabs has collaborated with Verified Clinical Trials to develop a subject authentication initiative to prevent “professional research subject” from enrolling in multiple clinical trials simultaneously. The initiative includes the authentication of subject identity and medical history, background checks, and tracking of prior study participation in order to eliminate ineligible subjects from clinical trials. It has been launched at Clinilabs’ Phase 1 sites in New York and New Jersey.
Study volunteers interested in free care or compensation may present inaccurate information in order to gain entry to clinical trials, and some may jump from one study to another without waiting for enough time to lapse between treatments. This type of research volunteer places everyone at risk including the drug manufacturer, the research site, and most importantly, themselves, potentially jeopardizing their health. Furthermore, this may compromise data quality.
For readers in the UK, the system has similarities with The Over-volunteering Prevention System (TOPS), which was launched by Dr Malcolm Boyce and colleagues in 2002 and is now operated by the UK Health Research Authority. TOPS currently has over 95,000 registered volunteers.