Telehealth platforms are gaining a strong foothold in primary care scenarios. Patients like the convenience and so do physicians. Virtual doctor visits are commonly taking the place of the traditional visit to the office and is saving both doctors and patients time and frustration. Of course there are still many instances when a video doesn’t cut it and a patient wants to connect with their doctor face to face or the doctor is required by law to see the patient in person before dispensing prescriptions or scheduling procedures. This same scenario holds true for virtual clinical trials.
As new virtual trial models emerge with assurances of streamlining the clinical trial process, it is crucial we stay vigilant of safety protocol. Clinical research staff have an important role to play and are critical for in-person visits when dictated by trial protocol.
Federal and State Regulations May Require In-Person Site Visits
Regulations from the Institutional Review Board (IRB) for Human Participants, as posted on the Cornell University Office of Research Integrity and Assurance website, state “In the planning and development of a research project, investigators must follow ethical principles for the protection of human participants involved in the research. Appropriate Federal and State regulations must also be followed in the conduct of the research. Additional guidance is provided from Cornell and other regulatory agencies to assist the investigators in developing and conducting the research projects.”
This means that certain types of visits, by law, must be conducted in person. Visits that include a physical examination or require certain medication to be dispensed are great examples.
Clinical Research Sites Play an Important Role
Virtual visits are an incredibly useful new solution to incorporate into traditional clinical trials. They are ideal for visits that require things like blood glucose level monitoring which can safely and easily be accomplished remotely. Yet, clinical research staff must continue to be a key element in the clinical trial process, necessary to answer questions during remote sessions and to meet patients in person for required on-site visits.
In addition, pharmaceutical companies often have a preferred network of research sites they like to work with for particular types of trials. It behooves all parties involved when Pharma works with sites that have conducted trials for them in the past and are already well-trained on specific procedures, thereby reducing the need for additional training on systems and processes.
VirTrial Works with Research Sites to Incorporate Virtual Options
With a long history in clinical research, the VirTrial team understands that a hybrid approach is more realistic than trying to transition to a 100% virtual trial. VirTrial works hand-in-hand with research sites to implement hybrid virtual clinical trials where 60 – 70 percent of visits are in person and 30 – 40 percent are virtual. This hybrid approach streamlines the process for sites, reduces the burden for patients, and results in improved patient retention and faster trial completions. Contact the VirTrial team for a one-on-one demo to see how the solution can benefit your site.