If you’re reading this article, whether or not you’re attending the online MedCity INVEST Digital Health conference, chances are that you’re doing so at home, possibly while wearing pajamas. The Covid-19 pandemic has kept much of the country in a state of immobility, severely wounding the many sectors of the economy that depend on people’s ability to travel, and clinical trials are no exception.
In May, Medable and Covance – the LabCorp-owned contract research organization – signed a deal to accelerate adoption of decentralized clinical trials, a trend that Covid-19 had been speeding up to begin with as the pandemic has made it more difficult to conduct trials that are dependent on traditional visits to brick-and-mortar sites.
In March, a survey of 170 trial sites conducted by Continuum Clinical found that many anticipated disruptions due to Covid-19, especially in terms of their ability to recruit and retain participants. Since then, their fears have been realized. An article in The Lancet last month reported that around 80% of non-Covid-19 trials, numbering in the thousands, have had to be stopped or interrupted due to the pandemic, with “tremendous” disruption to all biomedical research that is not directly related to Covid-19. Conference cancellations, disrupted supply chains for equipment and redirection of human resources from clinical research to emergency care for Covid-19 patients have all contributed.
But the pandemic, of course, won’t last forever. That raises the question of what will happen with the move toward virtual and decentralized trials after it has passed. It now seems unlikely that a vaccine against SARS-CoV-2, the virus that causes Covid-19, will become available before the end of the year, and perhaps not until well into next year.
“We were already seeing a significant shift in decentralized trials since before the pandemic,” said Alison Holland, head of virtual clinical trials with Medable, in a phone interview. “Covid-19 has accelerated it.”
The end of Covid-19 is not likely to put a stop to the trend. Holland pointed to the convenience of being able to have doctor appointments via telemedicine, allowing for greater flexibility. Virtual trials won’t necessarily be the norm everywhere, such as with drugs with high amounts of toxicity or that treat serious diseases such as cancers. But there could also be a mix of visits to trial sites or labs, as well as home monitoring.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“I suspect as we go forward, a lot more people will demand those choices, and the way in which we can be successful is not to mandate that people come to sites, but to give them choices,” Holland said.
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