Organizations are seeking novel methods to carry out clinical research. The following article discusses a completed remote clinical trial that employed a number of methods to achieve significant improvements in a number of functional areas.
The VERKKO study was a fully remote trial that improved compliance by 18% and reduced timelines by 22%. The trial design utilized a remote clinical trial model where a single ‘virtual site’ was used to support the entire population of 76 registered patients. The study was a phase IV study where participants completed a complex glucose profiling protocol.
Some of the benefits measured in VERKKO
Some of the complexities of this virtual site research model included:
- Age of patients – average age of completers was 59 years old, with several participants aged 70+
- Use and integration of a smart, connected blood glucose meter and a novel profiling protocol
- Study / site staff resourcing
In addition to evaluating the patient’s experience in a remote research model, the VERKKO trial was also innovative from the virtual site’s perspective and worthy of taking a closer look at the site experience.
Virtual Site Definition
A Principal Investigator, a study coordinator and a diabetes nurse provided the site functions for the remote study. They operated as a ‘virtual site’ as they did not physically work in the same location. The investigator was located at a diabetes clinic in Helsinki. The study was designed so that it was possible for patients to physically visit the site, although no visits were needed during the study conduct. Other resources were provided by Mendor Oy, the diabetes technology partner in the study.
Site Staff Roles and Responsibilities in Virtual Research
The first difference to a traditional study was that the investigator and the study coordinator were in physically separate locations, and in fact, they were from completely different organizations. The VERKKO virtual site model demonstrates the flexibility of study resourcing.
- The investigator performed duties mainly from the diabetes clinic.
- The study coordinator role was performed from the Mendor office and key duties consisted of providing logistical and technical support for patients.
- The diabetes nurse role was covered by two individuals, one at the clinic and one at the Mendor office who provided coverage for each other during absences.
Remotely Managing Trial Site Activities
Through the use of Clinpal technology, the investigator in the VERKKO remote trial had access to patient data, including bi-directional messages sent between the patient and the coordinating study nurse. The investigator’s only day-to-day task was to electronically counter-sign the consent forms after the study patient reviewed and electronically signed the eConsent. In practice, the investigator’s workload for study activities was minimal and site burden was greatly reduced.
The diabetes nurse resources were provided virtually by the study site and Mendor. The main responsibility was to review patient registrations and to support patients during the process. This involved:
- Responding to patient messages
- Reviewing patient data to spot issues with compliance
- Overseeing the logistics of study materials once the eConsent process was complete
Glucose profiling report used in the VERKKO study
Clinpal facilitated the workflow between the different stakeholders and made sure each party was aware of their tasks and completed them in a timely manner.
You may notice that the site staff did not have the typical patient recruitment responsibilities in Verkko. This is because the patient recruitment effort was driven by an online outreach campaign managed by Langland – the digital health advertising partner in VERKKO. The site staff simply needed to review the study participant requests to join the Verkko study and accept the suitable study candidates. As a result of this all inclusive/all user platform, we saw an 81% conversion of study candidate to study participant. This is another significant site burden that is almost completely eliminated using a remote model with online recruitment. It is also one of the low-risk tactics that can be easily deployed into any trial to boost recruitment and to help sites. The efficient recruitment process, combined with the elimination of physical site visits resulted in the site reporting having spent only one third of the effort required to manage the patients in the previous comparator trial.
The facilitation of tasks between the different roles in Verkko allowed for flexibility in resourcing – an appropriately trained resource could be located in any location – an enabler for ‘virtual’ remote trial activities.
In addition, the use of a purpose built end-to-end platform, such as Clinpal, allows virtual studies to be flexible, easily resourced and in many cases, more economical.
How Technology Supports the Site Staff in a Remote Research:
- Real-time access to all patient data to facilitate and improve compliance management
- Ease of communication with secure and private site-patient messaging
- Electronic library for all study materials providing easy access for patients and study staff
These sorts of studies are only achievable because of the unique aspects of an ‘all inclusive / all user’ platform that drives the interaction through its technology.
While patient centricity and privacy are very important, the site’s positive experience with technology-enabled clinical trials remains critical. The fully remote VERKKO study demonstrated that the adoption of technology offers many advantages for sites including more efficient and flexible working practices, increased compliance, and reduced timelines. For the sponsor or CRO, it allows for a highly flexible resourcing model. It is clear that the technology available today, such as Clinpal, provokes important new thinking around remote research models.
The next article in the virtual research series will focus on operational matters, including online patient recruitment and remote patient management. Watch this space for more!