Covid-19 Will Change the Future of Pharmaceutical Trials
May 18, 2020Covid-19 has caused great interruption to pharmaceutical trials, as most resources have shifted to finding a vaccine and many ongoing trials have been disrupted, according to a report by Wakefield Research, an independent provider of market research and market intelligence.
Social distancing guidelines, travel restrictions, the risk of infection, and associated recruitment problems have caused some pharmaceutical trials with no immediate participant benefits to pause or even be cancelled, the research reports.
The process for recruiting and retaining patients for clinical trials has changed little over the past 30 years, but in March Covid-19 caused both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to relax clinical trial regulations and allow certain aspects of pharmaceutical trials to be performed remotely, Wakefield Research said. When the world recovers from the pandemic, these remote trials will become a permanent fixture in the industry, Wakefield Research predicts.
Wakefield Research forecasts that, due to the changes occurring now as a result of Covid-19, future pharmaceutical trials will see several situations.
According to Wakefield Research, one of the differences will be the implementation of remote patient monitoring.
Traditionally, trial participants have had to report to hospitals, clinics, or other trial sites for monitoring. However, Covid-19 has revealed that many aspects of patient monitoring can be done remotely. Patients are now able to consent to treatment electronically and receive medication and/or monitoring equipment from pharmaceutical companies through
the mail. In the future, companies will also utilize smart watches and other wearable devices to continually monitor trial participants and check-in with them when issues arise, Wakefield Research said.
Furthermore, Wakefield Research sees the utilizatio nof virtual check-ups.
Check-ups for discussing study progress and participant outcomes will also be performed remotely, Wakefield Research says. By utilizing video calling, study participants will meet with researchers without having to travel great distances to trial sites and potentially exposing themselves to the risk of infection. Virtual check-ups additionally benefit clinical research assistants (CRAs) who will also no longer need to travel to trial sites, thereby saving both time and money, Wakefield Research said.
A better pharmaceutical trial infrastructure is yet another feature Wakefield Research predicts.
Covid-19 has caught many pharmaceutical companies off guard, necessitating quick adjustments on the fly, Wakefield Research says. The pandemic has exposed the vulnerability of the current pharmaceutical trial infrastructure, and thus made it possible to devise more responsive trial designs that will be more resistant to future disease outbreaks. This entails a greater strategic focus on vaccines and prevention among pharmaceutical companies, Wakefield Research said.
The above shift will not completely eliminate in-person pharmaceutical trials. Even predominantly remote trials will require occasional in-person check-ins or monitoring visits, Wakefield Research said.
Also, certain high-risk trials, like those in oncology, will continue to necessitate more frequent in-person interaction, it added.
Nonetheless, Wakefield Research says, a greater emphasis on remote trials is likely to permanently change the face of pharmaceutical trials in the future. By minimizing travel through remote trials, pharmaceutical companies will be able to recruit a more diverse participant pool, including more minority and rural participants, thereby producing better results.
Furthermore, Wakefield Research says, limiting travel will lower trial costs to both participants and pharmaceutical companies by minimizing the
cost of travel, while speeding up trials by eliminating travel-related scheduling barriers. The end result will be cheaper, faster, and more diverse pharmaceutical trials that will be better able to survive future disruptions, the research says.