Decentralized Clinical Trials Enable Participation for Immobile Patients
Clinical trials require a significant commitment from patients, particularly in regard to travel time to research sites for regular visits. Consider the additional patient burden involved in clinical trials for patients with paralysis, dementia, or other conditions that make travel difficult or impossible. Their immobility typically prevents them from participating in traditional on-site trials. If the trial protocol includes an option for decentralized clinical trial (DCT) visits via telemedicine, however, their ability to participate can become a reality.
Decentralized trial visits limit the demand for all visits to be done in-person, eliminating barriers to entry and increasing participant diversity. By incorporating DCTs, sponsors can be more flexible in developing protocols. DCTs enable PIs to maintain patient engagement and conduct remote safety check-ins, electronic questionnaires, and medication compliance via video, text, and email.
Combining DCTs with Home Healthcare
DCTs can also be combined with home healthcare professionals to safely conduct more involved visits. For instance, a registered nurse might visit a patient in their home and in conjunction with the physician, who is connected via the telehealth platform, conduct a physical exam. Once the physician gives the approval, the RN could administer an infusion or draw blood in the patient’s home.
Some trials may require a combination of on-site and decentralized trial visits. VirTrial’s Virtual Care Management (VCM) Program supports that requirement and enables sponsors to run hybrid decentralized trials using their preferred clinical site partners vs. a limited choice of sites. The platform is available for use at any site, adding flexibility for pharmaceutical companies, patients, and research sites.
In a study focused on the treatment of spinal cord injury/disorder, the sponsor shared the following comment:
“VirTrial’s partnership in our trial has opened doors for patients who would otherwise be unable to participate due to health and lack of mobility. Together, we are able to safely deliver and monitor our therapies for patients in the comfort of their homes. What this means for the world of cell therapy is nothing short of groundbreaking!” ~ Donna Chang, President and CEO of Hope Biosciences
To learn more about how VirTrial can add flexibility to your next clinical trial, contact us today.