Virtual and digital solutions are mainstays of life now more than ever, thanks in large part to the COVID-19 pandemic. It’s how we make doctor’s appointments and shop for groceries. It’s how our children get an education. It’s even how we celebrate birthdays and holidays.
Virtual solutions are now also a part of clinical development. During the spring and summer of 2020, clinical trial staff, sponsors, and CROs were forced to adopt digital solutions like remote monitoring and telehealth visits in order to maintain or restart trials—and it worked. A series of surveys of clinical trial staff showed that the adoption of digital solutions may have contributed to the slight rebound in the number of active trials seen in the fall.
Operating without a playbook
Digital solutions offer relief from many of the challenges of clinical trials. The whitepaper New Ways to Conduct Clinical Trials: Gaining Confidence, reviews these benefits. Off-site visits lower the risk for disease transmission, offer study participants added convenience, can lead to faster enrollment, and can help assuage the mounting financial concerns of site staff. This support is much need by oncology trials, for example, that recent news and a study in JAMA Network Open reports have faced a 60% decline due to the COVID-19 pandemic.
But how do we get there? How do we change decades-long approaches to clinical development when the time to learn and adapt is as small as the room for error?
There are no best practices for virtual clinical trials. Study participants, site staff, CROs, and sponsors are learning as they go. But these virtually-enhanced trials are testing more than treatments and products and are producing more than clinical data. As such, those in clinical development need more than protocols and outcomes to guide the way and measure success.
Pretrial testing: the insights to adapt
One way to identify future obstacles to digital integration is to pretest trials with clinical site staff and potential study participants. Getting insights on the feasibility of remote monitoring, the ease of virtual visits, or the electronic entry and submission of data, for example, can yield valuable information that can lead to better adherence, efficiency, and user satisfaction.
Pretrial testing of protocols also addresses a long-felt push to increase patient engagement and enhance patient centricity. Involving study participants and their caregivers in the development of the study protocol and trial experience underscores the importance of active participation in one’s healthcare, which is critical during a time in which chronic care is an increasing a burden on the healthcare system.
Clinical SCORE has been working with clients to pretest their protocols, identify obstacles, and make the changes needed for more efficient and productive trials. As Blaine Cloud, Senior Vice President, summarizes, “Pretrial testing helps clinical stakeholders know what they don’t know.” Oftentimes, that is the data needed the most.
To learn more about pretrial testing or service offerings, contact Blaine Cloud at firstname.lastname@example.org.