Improving Safety and Preventing Failure in Clinical Trials by Detecting and Preventing Duplicate and Professional Research Subjects: The Case for Use of a Research Subject Database Registry

Abstract

Objective: Annually, billions of dollars are spent worldwide on drug development and the associated clinical trials conducted. Therefore, it is vital that pharmaceutical companies who sponsor clinical trials ensure that their data is accurate and timely. Numerous challenges for clinical trials exist and include recruitment and enrollment of appropriate research subject. Potential candidates for these studies are recruited and incentivized to participate in trials. While a great number of people participate in clinical trials solely for altruistic reasons, compensation for time and travel does motivate many potential research subjects. For others without adequate health insurance, the impetus is the evaluation and treatment with investigational products at no charge for their own potential health conditions. For both safety reasons and purposes of data integrity, it has long been held that research subjects should not volunteer in more than one study at a time. Also, there is typically a minimum 30-day waiting period or “washout period” between studies. These criteria are difficult to verify and thus we explored the development of a global regulatory compliant database that collects information on the exact research subject’s study history to detect multiple potential pitfalls and protocol violations that would be of immeasurable benefit to strengthen clinical trial data. Our study shows that subjects are neither always compliant nor forthcoming. There are attempts to screen more than once; there are age violations, washout period violations, and other violations that might cause poor quality data in a trial. Verified Clinical Trials (VCT) is the world’s largest and most comprehensive research subject database. By utilizing VCT, a sponsor can ensure that their subjects are verified and are not either enrolled in another clinical trial, still in their washout period, or in violation of any other protocol criterion.