The Patient Direct service is designed to enable sites and sponsors to continue trials in the face of disruptive events, such as the current COVID-19 pandemic. It enables ‘clean’ transport for needed medications, medical equipment and staff for treatment and monitoring.
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) both have issued guidelines for conducting clinical trials during the spread of the virus. The guidelines empower sponsors to explore alternative methods and ways to ensure the continued safety of participants and staff.
Continuing trials
Jim Murphy, Greenphire CEO, told Outsourcing-Pharma that the existing ConneX patient travel service served trials well, in enabling transport of patients to a clinic for trial activity, then safely back home. The COVID-19 pandemic, however, disrupted the typical flow of participants.
“As the pandemic spread, it became very clear that medically fragile patients were unable to go to clinical trial sites,” he told us. "Through conversations with sponsors and sites, as well as in our 1,800+ person site survey and recent FDA/EMA guidance, it was clear that new stresses have emerged, and that existing travel patterns and services don’t meet the needs of today’s challenging environment.”
Site survey
The company developed the Patient Direct service in response to the survey, which polled site personnel across the globe on the impact of COVID-19. Findings of the survey include:
- 69% of survey respondents are using technology to support at-home patient care.
- 60% would use a service that would transport medical equipment and/or medicine to the patient’s home.
- Almost 48% would find a service that would facilitate the travel of site personnel to patients’ homes to conduct regularly scheduled visits useful.
- Nearly 55% are open to patients going to an alternative, closer facility for tests or visits in an effort to keep the patients in the trial.
Additionally, one respondent, when asked what their site was doing to help meet patient needs, indicated staff were conducting telephone monitoring, medical accompaniment of the research subjects, and traveling to participant homes to collect samples and deliver medication.
“I live nearby an elder patient and did not want them to travel by bus because of potential contact with infected commuters,” the respondent indicated. “I transported the patient in my car.”
Addressing concerns
Murphy told us the ConneX Patient Direct service helps address the needs and concerns expressed by site personnel by making it possible to safely send medicines, equipment and site team members to participants’ residences.
“This globally available service can also support traditional visit flows involving patients traveling to the clinic but does so using medical grade clean ground transportation,” he said. “This new flow of travel keeps the patient, site and study on-track by ensuring treatments are available to the patients who depend on them.”
Murphy indicated Patient Direct is a permanent addition to the ConneX service suite. He added such direct-to-patient services can serve as an effective addition to decentralized trials and telemedicine trial programs.
