Verified Clinical Trials (VCT) and the Alliance for Clinical Research Excellence and Safety (ACRES) have launched a partnership.
VCT has pledged use of its proprietary software technology and access to the research subject clinical trials database registry to ACRES member research sites.
VCT, a clinical trials database registry to stop dual patient enrollment, promotes safety and data integrity by preventing research participants from simultaneously screening and enrolling in multiple clinical trials. The implications of dual enrollment include safety concerns when multiple investigational products are combined. Furthermore, there are altered efficacy and placebo rates when patients do not actually take the study medication and provide false responses. This places the research site, CRO, and, most importantly, the patient at increased risk.
ACRES, a Cambridge-based nonprofit dedicated to enhancing quality, safety, integrity and operational effectiveness in drug development and health research through building a global system for clinical research, promotes improved safety and data quality as one of its global foundation initiatives.
By making available a global database of current research participants, the partnership will enable all clinical trial stakeholders the ability to screen and enroll only qualified patients. The VCT Direct Connect Program will allow sponsors and CROS for the first time to directly contact patients, instantaneously disseminate new safety information if needed, provide study-related results at completion and recruit for registry studies and future clinical trials, with patients’ permission while respecting their privacy.
Mitchell Efros, M.D., FACS, CEO of Verified Clinical Trials, said, “Contributing VCT's time and resources to ACRES benefits the industry as a whole by using technology and new tools to dramatically improve safety and data quality. By allowing access to the research subject clinical trials database registry, the industry will build a collaborative system that serves everyone—investigators, sites, CROs, sponsors, regulatory agencies, the healthcare industry and, most importantly, the public."
Kerri Weingard, chief operating officer of VCT, said, "For too long, the industry has failed to recognize and act upon dual enrollment in clinical trials and the need to protect the safety of the research subjects and the data quality from the trials we conduct. We now have the tools and the solution to satisfy an exclusionary criterion that is listed in every protocol. The criterion states a research subject may not be simultaneously enrolled in another clinical trial or have a washout for a specified period of time from their previous trial."
“ACRES welcomes VCT as a strategic ally to benefit sites, sponsors, regulators and ethics committees worldwide. We share a dedication to promoting research subject safety first and foremost with evaluable data, beginning with recruitment, as both an ethical and scientific non-negotiable,” said Matthew Whalen, ACRES chief operating officer. “When it comes to patient recruitment, retention and compliance, we both operate from an understanding of the necessary integrity of safety and data quality… including from where it starts: to prevent simultaneous enrollment and the impact of the ‘professional subject’ in more than one trial at a time.”