MedVector has started rolling out its Prime-Control Technology, a tool designed to help contract research organizations (CROs) and sponsors access to a larger pool of patients, without the need to start new clinical trial sites. It helps study teams reach point-of-care providers, non-participating doctors, specialists, and potential patients in far-flung areas, to increase the potential patient population.
MedVector CEO Scott Stout spoke with Outsourcing-Pharma about Prime-Control Technology, how the tool works, and the importance of broadening patient populations for clinical studies.
OSP: Could you please tell us a bit about the challenges trials typically face with patient ID and enrollment?
SS: Clinical trials hit roadblocks because they often lack access to qualified subjects and as a result, new medications can take up to 10 years to get through all phases. The problem we’re addressing is that many patients who are eligible for clinical trials are prevented from participating because their point of care doctor is not a research physician.
While most doctors and specialists believe in the importance of advanced medicine, they typically don’t refer to clinical trial sites nor are unwilling to go through the effort and complications of acting as a Principal Investigator. To make matters worse, even the doctors willing to participate have a less than 40% chance of being selected to participate in the study; this shows that access to the patient data used to identify subjects is worthless without the access to the subjects themselves.
Another problem MedVector will be able to address is the ability to access participants in rural communities and inner-city hospitals which combats the current diversify imbalance.
OSP: Then, could you please explain some of the benefits of trials expanding their reach beyond their existing sites?
SS: Volumes at selected clinical trial sites are very low, which means unless a location is a dedicated clinical trial site, it becomes a financial burden on the participating practice. Pharma has been looking for ways to better incentivize participating doctors, but Stark laws prevent further greasing the wheels.
MedVector enables subjects to participate from their local doctor’s office, which allows that physician to offer advanced medicine without acting as the principal investigator and creates larger volumes at participating sites. This simple solution unlocks access to millions of patients that CROs already have identified but cannot access.
Our system now gives CROs and patient recruitment companies access to the vast majority of patients identified without building or triggering new sites. Setting up a site is costly, and each new site is an additional expense and risk. It requires a principal investigator to travel from site to site, which during COVID has been challenging.
OSP: Could you please provide some detail about how Prime-Control technology works? How does it ‘free up’ some of these untapped sources?
SS: Most studies have four types of data: labs, scans, verbal, and visual. Verbal and visual data is the perfect use case for telemedicine and labs and scans are becoming more and more centralized, meaning blood draws can be sent directly to central labs and scans can be digitally sent to central radiology.
MedVector’s Prime-Control Technology enables principal investigators (PIs) to virtually monitor subjects face to face while subjects remain at their local provider’s office, data is entered by the PI exactly the same way as if the patient were physically in the room.
Working in partnership with the CRO, prior to an appointment, MedVector ships a shoebox-sized device to the subject’s local healthcare provider. The plug-and play-unit automatically connects to the appropriate clinical trial site, and the PI controls the entire live-session as if the PI and subject are in the same room.
At the subject’s location, the local nurse assists the PI -- drawing blood, measuring vital signs, and performing other generic procedures under the “supervision” and “delegated authority” of the PI. The PI enters all clinical data, adhering precisely to the same protocols for all appointments, and maintaining the same good clinical practice (GCP) as a traditional clinical trial appointment.
OSP: Why do you think non-participating organizations (hospitals, private practices, etc.) tend to be protective of their current patients?
SS: Doctors are very protective of their patients. Not only are their patients their clients, but more importantly doctors are also driven to provide quality care.
Referring to a specialist is usually at the request of the patient but referring to a clinical trial is mostly the doctor’s responsibility. MedVector now allows doctors to enhance their quality of care by offering access to advanced medicine while keeping the patient within the practice.
OSP: How can trial teams reassure them they’re partners, not competitors?
SS: MedVector reassures point-of-care providers by keeping the patients within the practice. No referring away, no competition.
OSP: Do you have anything to add about MedVector, Prime-Control or anything else?
SS: MedVector is the only company that partners with CROs, sponsors, and patient recruitment companies to expand subject participation beyond existing clinical trial sites. The industry spends billions of dollars annually on patient recruitment for new patients.
Most of the time, the industry knows where to find subjects but doesn’t have access to them. It is driving up the cost of medical innovation, drug development, and in the long run, risking lives. With MedVector, no patient is too far away or left behind.