Gal Cohen
In his keynote, Gal Cohen, head of scientific affairs at North Carolina-based Rose Research Center (RRC), which specializes in tobacco dependence research, including research on smokers, addiction, smoking cessation, tobacco harm reduction and the use of other tobacco products, discussed the opportunities offered by e-research versus traditional in-lab clinical studies for clinical trials in the field of vaping as the technology for virtual trials is maturing.
One of the crucial issues in a clinical trial is recruitment. In a typical trial setting, Cohen concluded from a comparison of 100 recently completed e-cigarette randomized controlled trials, many studies are underpowered and thus limited in scope as the intended number of subjects is often not recruited. Eighty percent of clinical trials finish late, and 20 percent are delayed for more than six months. Cohen said that it was not unusual for recruitment to take up to four years. Costs for clinical procedures, administrative staff, site monitoring, recruitment and retention as well as a laboratory were named as the top cost drivers.
The virtualization of trials, on the other hand, offers an opportunity to reduce recruitment time and facilitate larger trials, improve data quality and trial execution. Several developments facilitate this trend, among them smart phones and improved connectivity. In the U.S., for example, there is one cell phone per individual; in Russia there are close to two per individual. Meanwhile, connected sensors can use modalities such as breath or heart rate to track biomarkers like exhaled carbon monoxide. GPS shows where a current use pattern takes place and allows for detailed analyses. Despite the obvious advantages of e-trials, though, there are still instances where you want to bring the subject into a lab, Cohen said. Abstinence or quitting, for example, are best studied in a controlled setting.
The RRC recently introduced eResearch, the first mobile clinical research platform for volunteers who want to advance research in nicotine, smoking cessation and harm reduction. Implementation takes place via a cloud-based platform, and participants have access through an app on their phones. On the other side, there is an administrator who is running the study and monitoring it. The system includes a secure database and offers the opportunity to bring in data from other apps and devices.
The phases of a clinical study are also represented in the virtual study. The setup is designed for easy use and features a web administration portal, customizable study design, volunteer profile management and role-based access and permissions. Recruitment, screening and verification of eligibility involve scanning a driver’s license, taking a picture and validating that a volunteer is the right participant, and a medical eligibility screening. Clinical study process management includes connectivity with PayPal or other payment portals so that participants can get immediate monetary rewards if they achieve certain goals. The platform is globally scalable. For the last phase, data management, there is a dashboard with data export and visualization, which is updated in real time.
The advantages of virtual trials, Cohen summarized, include scalable recruitment, ease of compliance for participants, ease of administration, real-world use patterns and connected diagnostics, devices and apps on top of a compliant quality system.