Verified Clinical Trials (VCT), the research subject clinical trials database registry to stop dual enrollment in clinical trials to improve safety and data quality in clinical trials, and the Alliance for Clinical Research Excellence and Safety (ACRES), a Cambridge-based non-profit organization dedicated to enhancing quality, safety, integrity and operational effectiveness in drug development and health research through the building of a global system for clinical research, announce their strategic alliance.
Verified Clinical Trials is dedicated to promoting safety and data integrity by preventing research subjects from simultaneously screening and enrolling in multiple clinical trials. The implications of these actions include safety concerns when multiple investigational products are combined. Furthermore, there are altered efficacy and placebo rates when subjects do not actually take the study medication and provide false responses. This places the research site, CRO, pharmaceutical sponsor, and most importantly the research subject at increased risk.
Verified Clinical Trials has pledged use of their proprietary software technology and access to the research subject clinical trials database registry to ACRES member research sites. The Verified Clinical Trials technology provides a platform to enhance safety across all clinical trials by verifying screening and enrollment status of the research subject to prevent dual enrollment in clinical trials.
Promoting improved safety and data quality is one of ACRES’ global Foundation Initiatives. By making available a global database of current research subjects the partnership will enable all clinical trials stakeholders the opportunity to screen and enroll only those research subjects that are qualified to do so. Furthermore, the Verified Clinical Trials Direct Connect Program will allow sponsors and CROS for the first time to directly contact subjects, instantaneously disseminating new safety information if needed, as well as providing study-related results at the completion of study and recruitment for registry studies and future clinical trials while respecting the research subject’s privacy and with permission.
“I am excited and honored to be involved with ACRES’ innovative cause,” said Mitchell Efros MD FACS, CEO of Verified Clinical Trials. “Contributing Verified Clinical Trials’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 and the healthcare industry, and most importantly the public.”
Kerri Weingard, COO of Verified Clinical Trials, noted that “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 Verified Clinical Trials as a Strategic Ally to benefit sites, Sponsors, regulators, and ethics committees world-wide. 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 ACRES COO Dr. Matthew Whalen. “When it comes to patient recruitment, retention, and compliance,” he added, “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.”
About Verified Clinical Trials
Verified Clinical Trials is the world’s leader in the field of research subject clinical trial database registries, proactively improves research subject safety and data quality in clinical research trials by halting dual enrollment in clinical trials. With a web-based solution designed to enhance the quality of both early and late phase trials, VCT has the scalability to reach all sites nationally and globally.
ACRES, a global non-profit organization working in the public interest and based in Cambridge, Massachusetts, is building a comprehensive, sustainable and shareable system for clinical research worldwide. By bringing together experts, stakeholders, and like-minded organizations, ACRES’s goal is to collaboratively create and implement systems solutions that enhance safety, data quality and integrity, and operational excellence in an efficient and cost effective manner to improve the health and lives of people everywhere. For additional information on ACRES’ global Foundation Initiatives, please contact: Dr. Mary Tobin, Special Adviser to the CEO at firstname.lastname@example.org