Clinilabs, the US-based contract research organisation (CRO) focused on early-phase and speciality drug development services, has joined forces with Verified Clinical Trials (VCT) to launch a subject-authentication initiative at its Phase 1 trial sites in New York and New Jersey.

VCT was set up in the US to combat dual enrolment in clinical trials by maintaining a fully web-based registry of research subjects. More recently, VCT has expanded its offering to include subject-recruitment and medication-adherence tools.

Clinilabs is implementing VCT’s clinical-trials database registry system, which is designed to stop professional research subjects from enrolling in multiple clinical trials simultaneously.

The joint initiative includes authenticating subject identity and medical history, background checks, and tracking prior study participation to eliminate ineligible subjects from clinical trials.

Explosive issue

According to Dr Mitchell Efros, chief executive officer of Verified Clinical Trials, recognition of dual enrolment in clinical research and use of the VCT system have “exploded” of late.  

“Clinilabs has joined the largest clinical-research database network across North America and only strengthens this co-operative registry,” Efros commented.

Failure to document the identity of study volunteers, inaccuracies in subjects’ medical histories and multiple concurrent enrolments are now a “serious problem” in the clinical research arena, Clinilabs pointed out.

Professional research volunteers place “everyone at risk including the drug manufacturer, the research site, and most importantly, themselves, potentially jeopardising their health”, the CRO said. Dual enrolment may also compromise data quality, it noted.