ByMoe Alsumidaie - February 20, 2024
ByThe prevalence of duplicate participants in clinical trials poses significant risks, compromising the integrity of data and the safety of the patients involved. To delve into this matter, we spoke with Kerri Weingard, a seasoned veteran in the field and the co-founder of Verified Clinical Trials (VCT), who brings a wealth of knowledge and experience. In this interview, she elaborates on the cutting-edge technology VCT developed to tackle the complex issue of duplicate participant enrollment in clinical trials. Her insights offer a window into the innovative strategies employed to enhance clinical research’s reliability and safety in today’s clinical research environment.
Moe: How Does VCT Address the Challenge of Duplicate Participants in Clinical Trials?
Kerri Weingard: The inception of VCT was driven by our direct experiences in clinical research, where we frequently encountered the issue of participants enrolling in multiple trials concurrently. These issues of duplicate enrollment most often go undetected. Our solution, a comprehensive database and technology system, is initiated after a participant’s consent. It allows the research team to input participant data into the VCT database and then compare this information against the current trial’s inclusion and exclusion criteria. This system can instantly identify if a participant is already enrolled in another trial, has been part of a previous trial, is attempting to enroll in multiple trials simultaneously, or is violating other protocol criteria like washout periods. It’s a straightforward yet highly effective tool that tackles the problem of dual enrollment head-on.
Traditional methods cannot efficiently track participants across different trials and sponsors. VCT’s approach, in contrast, offers early detection at the time of screening and prevention of duplicate participation within the same trial and across other trials. This proactive approach is crucial for conserving resources and ensuring that each trial maintains its integrity and that participants remain safe by adhering to one trial at a time.
Moe: How Can VCT’s Methodology Enhance Patient Safety and Data Quality in Clinical Trials?
Kerri Weingard: One of the key aspects of clinical trials, especially in early phases, is determining the safe dosage levels and understanding the side effects of investigational products. When participants enroll in multiple trials, they risk unknown drug interactions, which can lead to serious adverse events. VCT’s technology mitigates such risks by preventing duplicate dosing and enrollment. This strict adherence to trial protocols upholds patient safety and ensures that the data collected is of the highest quality. When participants are honest and compliant, the data reflects the true efficacy and safety of the investigational product.
Moe: How Does VCT Maintain Data Privacy Regulations in Different Countries?
Kerri Weingard: While VCT operates independently of FDA regulations, we are deeply committed to patient privacy and adhere to regional regulations, including the GDPR and localized privacy laws and regulations across the globe. Our system’s design primarily focuses on collecting the minimal necessary participant identifiers while maintaining the highest data protection and privacy standards. This task involves more than mere compliance; it requires a meticulous approach to handling sensitive data. To ensure clarity and transparency, we utilize detailed, localized, country-specific authorization forms. These are not standard templates but carefully crafted documents that respect each region’s unique legal and cultural nuances. This level of detail in our data handling practices is paramount for ensuring comprehensive understanding and trust among participants globally.
Moe: What are the Future Plans for VCT in Evolving Clinical Trial Management?
Kerri Weingard: Looking forward, VCT is not just focusing on the present issues but also anticipating future needs in clinical trial management. We are developing a facial recognition app to enhance exacting participant verification, which is particularly useful in decentralized and remote trials. Our upcoming recruitment app aims to connect eligible participants with new trials more efficiently, ensuring adherence to protocol criteria. Another exciting and significant innovation for 2024 is patient tokenization, which will allow us to give back to the patient community by sharing study results, safety information, and even trial arm allocation post-study. This initiative is designed to acknowledge the value of participants in the research process and keep them engaged for future studies.
Summary
The implications of VCT’s advancements extend beyond mere operational improvements; They signify a crucial shift towards heightened safety and integrity within clinical trials. By effectively identifying and preventing duplicate enrollments, VCT’s solutions ensure that each participant’s data is unique and reliable.
Moe Alsumidaie
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
