The COVID-19 pandemic has created unique challenges for CNS researchers. Unlike other therapeutic areas, many instruments used to determine drug efficacy are generated not by lab work, but by clinician or patient generated outcomes and assessments. This has left study teams with the difficult task of maintaining patient safety while continuing to develop new life-saving medications. Thankfully, technologies like telehealth (also known as virtual visits or telemedicine) have spent years being perfected in the healthcare setting and are now ready for widespread use in clinical trials. CNS researchers in particular are positioned well to benefit from its use, with many cognitive assessments able to be completed during a telehealth visit.
Well Developed Technology
Considering the first iPhone only launched in June 2007, it is remarkable how advanced smartphones and the onboard cameras they include have become. Today’s average smartphone is equipped with HD video cameras and can cost under $200 for entry models. Smartphone adoption rates also continue to climb, with 79% of people aged 50 – 64 and 53% of people 65+ owning a smartphone according to a recent Pew Research Center report. Likewise, the software solutions needed to leverage this hardware are also well developed, with telehealth software being widely used in medical care for years.
eCOA solutions with integrated telehealth capabilities allow clinicians to perform cognitive assessments remotely.
Clinical Assessments and Outcomes
Today any number of assessments, like the MMSE and MMPI, can be done using the right eCOA and telehealth solutions. By combining these technologies together, sponsors can provide an easy-to-use tool for clinicians to consistently grade and assess the cognitive state of patients remotely. By providing larger screens for clinicians, symptoms such as drooping eyelid, facial asymmetry, and difficulty rotating or turning can easily be detected during a virtual visit. Even drawing objects, a requirement of the MMSE, can be done using a smartphone or tablet to have the patient draw shapes.
The Right Thing to Do for Elderly Populations
For the many elderly patients afflicted with neurodegenerative disorders, even before COVID-19, site visits were an all-day affair. Visiting the hospital means traveling, likely with a caregiver, or the use of expensive cab services. They may be asked to wait for long periods, shuffled from one room to the next, and require meals. Their safety may also be at risk, with the danger of falling or being exposed to dangerous pathogens, including COVID-19. When you look at the technologies available today, there simply is no need to ask patients to carry the burden and risks associated with in-person visits beyond their initial patient intake.
What Regulators Say
Even if the technology and patient benefits are clear, it means little if their adoption interferes with regulatory approval. Study teams preparing for clinical trials should (and must) get the FDA to approve their protocol. And while sponsors should review these tools with the FDA, a recent rule change has clarified that sponsors can move forward with leveraging remote engagement tools wherever necessary and feasible, highlighting a few key considerations:
- Feasibility of assessment method
- Variability in data collected remotely
- Appropriate audit trail documentation
- Available technology and technical support required
To Sum It Up
The widespread availability of inexpensive smartphones with high-quality cameras, easy-to-use telehealth software solutions, and with guidance from the FDA, study teams must ask themselves whether it makes sense to continue requiring in-person visits for clinical assessments, especially in elderly populations. Even after the COVID-19 pandemic passes sponsors should continue to leverage these technologies to create a safer, less burdensome experience for patients in neurological clinical trials.
- “Demographics of Mobile Device Ownership and Adoption in the United States.” Pew Research Center: Internet, Science & Tech, Pew Research Center, 12 June 2019, www.pewresearch.org/internet/fact-sheet/mobile/.
- United States, Food and Drug Administration, “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency, 2020.