During the regional lock-downs of the COVID-19 pandemic, telemedicine became a popular option for patients to see and interact with healthcare providers without visiting their offices. The initial motivation to move to telemedicine was to prevent the spread of COVID-19 and enhance patient safety. Since then, telemedicine and other tools have gained popularity and provided exceptional support for patients in a remote setting.
In a parallel track, the conduct of virtual clinical trials has also become extremely popular. Before the pandemic, there was interest in exploring the possibility of virtual trials. However, the pandemic is what truly pushed research teams to “think outside the box” and make significant progress toward complete virtual trials. Site closures, quarantines, travel limitations, and supply chain issues for investigational products made it difficult for clinical trial teams to meet protocol-specified procedures such as protocol-mandated lab or diagnostic tests or healthcare visits.
Academic institutions and clinical researchers around the world quickly pivoted and designed new ways to interact with clinical trial participants. New technologies emerged, and existing technologies were enhanced or used in new ways. The result was a renewed interest in improving the patient experience and helping research teams engage patients remotely. In March 2020, the US FDA released “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards.” The guidance was updated numerous times throughout the pandemic, with August 30, 2021, as the most recent update.
Virtual Clinical Trials Today
Today, electronic data capture (EDC), wearables, and other devices for electronic patient-reported outcomes (ePRO), remote eConsent, and telehealth enable remote patient participation. However, some clinical trials in therapeutic areas such as oncology require periodic patient visits for imaging, biopsies, and other medical procedures that require specialized equipment or expertise. These clinical trials are typically designed as hybrid trials where some patient visits are conducted at a site facility, and some are via telehealth. A recent Science 37 Survey suggests that 77% of research executives expect to conduct clinical trials using remote patient monitoring, eConsent, ePros, telemedicine, wearable devices, and mobile nurses in the next 12 months.
Clinical researchers hope that virtual trials will reduce the patient burden and potentially lead to the acquisition and retention of expanded trial populations that are more diverse. To ensure that clinical trial participants represent the patients that will use a medical product, many clinical trial teams seek participants from more diverse and inclusive populations. Virtual clinical trials may provide a mechanism to connect with previously underrepresented groups, including racial and ethnic minorities and people of different ages.
The potential benefits of conducting virtual and hybrid trials for patients are significant. That doesn’t mean there aren’t challenges, especially for site teams who must learn new procedures and technologies used within the clinical trial ecosystem.
Let Vitalief Help You Move Towards Virtual and Hybrid Clinical Trials
The pandemic truly motivated the clinical research industry to make significant strides in virtual clinical research. There is still a great deal to learn. But the industry has proven that open-mindedness, creative thinking, enabling technologies, and commitment, have enabled researchers and health authorities to pivot quickly and deliver innovative medicines to patients with unmet needs.
Not sure how to navigate your organization towards a virtual or hybrid clinical trial? Let Vitalief offer support and guidance to help your organization shift towards future clinical trials. Contact us today to learn more about our solutions and how we can assist with hiring the right staff, clinical trial support, processes, and more.