We applaud NIDA for utilizing our service in order to help reduce the issue of dual enrollment in clinical trials.
Garden City, New York (PRWEB) August 13, 2015
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. These actions by the research subject place the research site, CRO, pharmaceutical sponsor, and most importantly the research subject at increased risk. Substance abuse clinical trials are especially prone to these issues and therefore the Verified Clinical Trials research subject database registry will be utilized in this upcoming trial with NIDA.
Verified Clinical Trials (VCT) will work with NIDA to use the VCT proprietary software technology to provide access to the research subject clinical trials database registry. Verified Clinical Trials technology provides a platform to enhance safety across trials sponsored by many pharmaceutical companies and CROs verifying screening and enrollment status of the research subject to prevent dual enrollment in clinical trials. The Verified Clinical Trials system will also provide the necessary tools to reduce the risk of several other important protocol violations that might never have been prevented. By making available a global database of current research subjects the technology will enable all clinical trials stakeholders the opportunity to screen and enroll only those research subjects that are qualified to do so based on their research study history and washout status.
Mitchell D. Efros, MD FACS and CEO of Verified Clinical Trials, noted "The clinical trials industry as a whole has been slow to recognize and act upon dual enrollment in clinical trials. The industry needs to protect the safety of the research subjects and the data quality from the trials we conduct. Prior to Verified Clinical Trials, the industry did not have the necessary tool and solution to satisfy many of the exclusionary criteria that are listed in every protocol. The criteria state a research subject may not be simultaneously enrolled in another clinical trial or must have a washout for a specified period of time from their previous trial. Furthermore, other important protocol violations could not be prevented. These include proper washout from past investigational compounds or prior use of the same investigational compound or compound class exposure to name just a few. Verified Clinical Trials is unique with regards to preventing numerous additional protocol violations.”
Kerri Weingard, ANP and COO, stated “We applaud NIDA for utilizing our service in order to help reduce the issue of dual enrollment in clinical trials.” Ms. Weingard further explained, “Use of an IVRS or EDC system to attempt to catch suspected dual enrollees is not truly effective and has many limitations when crossing Sponsors and disease entities. Unless one is using a research subject database registry, such as Verified Clinical Trials, the information will not detect activity across other sponsors, CROs, and CPUs. The staggering metrics of dual enrollment and protocol violations based on prior enrollment status in clinical trials has been staggering to witness with the use of VCT. Verified Clinical Trials will prevent these common yet avoidable protocol violations everyday and the issue is particularly pronounced in CNS, pain, and substance abuse clinical trials.”
The National Institute on Drug Abuse (NIDA) supports most of the world’s research on the health aspects of drug abuse and addiction and is a component of the National Institutes of Health, U.S. Department of Health and Human Services. The Institute carries out a large variety of programs to inform policy and improve practice.
About Verified Clinical Trials:
Verified Clinical Trials is the world's leader in the field of research subject clinical trial database registries. Verified Clinical Trials proactively improves research subject safety and data quality in clinical research trials by halting dual enrollment in clinical trials. Utilizing an entirely 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. The database includes multiple pharmaceutical sponsors, CROs, and research facilities.