AXIS Clinicals USA, a Dilworth, Minn.-based CRO, has partnered with the Verified Clinical Trials (VCT) national clinical trial database registry to stop attempts at dual enrollment in clinical trial research, thus preventing protocol deviations, improving data quality and promoting subject safety. Within the first seven days of use, the VCT system proved its worth by stopping a subject’s attempt at dual enrollment. VCT is the largest North American database registry in both early and late phase clinical trials.
Simultaneously enrolling in multiple clinical trials, also known as dual enrollment, has become a serious problem in the clinical research world as research volunteers attempt to jump from one study to another without waiting for the appropriate amount of time to lapse between studies. This is typically done in an effort to earn more money or receive free care. By doing this, others are placed at risk including the drug manufacturer, the research site, and, most importantly, the volunteer. Furthermore, this may result in issues with the data quality.
VCT also has partnered with the National Institute on Drug Abuse (NIDA) to use the VCT proprietary software technology to provide access to the research subject clinical trials database registry.
Mitchell D. Efros, M.D., FACS, and CEO of Verified Clinical Trials, said, “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 tools and solutions 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.”
NIDA supports most of the world’s research on the health aspects of drug abuse and addiction and is a component of the NIH of the HHS. The Institute carries out a large variety of programs to inform policy and improve practice.