Along with its direct impact on human health and survival, COVID-19 is indirectly impacting health by causing many companies to hit the pause button on clinical trials. Hundreds of studies have been suspended, and many more are pushing out their start dates. The reasons are many:
- Site closures
- Risk of infection from visiting a medical care facility
- Travel limitations
- Interruptions to the supply chain
Even when companies would like to proceed, research institutions may prohibit it. These delays are devasting for patients desperate for treatment, and companies anxious to provide it.
Fortunately, many drug developers have found a way to continue trials. The FDA has been quick to provide guidance designed to allow research to continue while keeping patients safe. Some studies have adapted to current challenges using telehealth instead of in-person consultations, sending healthcare professionals into the home to do blood draws and delivering pharmaceuticals to patients’ homes.
Even complex therapies, such as infusions, have transitioned from administration in the clinic to administration at home, following FDA guidance that suggests sponsors “consider the safety risk to trial participants who would miss an investigational product infusion because of the inability to come to the clinical trial site.” There is much to be learned from those resilient drug developers and researchers who have successfully adapted.
The increased adoption of telehealth and in-home care during COVID-19 has created a behavioral shift that may last long after the epidemic is over because it benefits patients, particularly those with conditions- such as cancer, that put them at greater risk of infection. Evidence suggests that for patients like these, home-based care delivers better health outcomes and quality of life at a lower cost. Models that include home visits by nurses and physicians, home infusion, remote monitoring and laboratory tests have been used successfully abroad and are gaining traction in the US.
The Take-Away for Rare Disease
Telehealth and in-home care are also options to consider for orphan drugs, since patients with rare diseases are often immunocompromised or have mobility challenges that make travel to a clinic difficult. Considering the patient’s viewpoint should also include arranging for expert in-home support services for monitoring, drug administration and bio-sample collection.
In small rare and ultra-rare populations, patient-centeredness in design and conduct of trials is critical to success. The same principles apply whether you’re running a clinical trial or looking at patients’ post-market experience on drugs – and there is the same need to plan for seamless and integrated data collection throughout.
Looking to the Future
One of the hard-won lessons of this time is that every study needs an emergency preparedness plan that spells out details on remote monitoring visits, HIPAA compliance for telemedicine, eConsent, notifying study participants of changes to study visits, etc. This is becoming increasingly important as the frequency of both pandemics and natural disasters is rising.
COVID-19 has taken a dreadful toll on our health and economic well-being, but it has also provided us with an opportunity to rip up the rule book and design new ways of caring for patients that may ultimately be to the benefit of all.