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The Disruption Series: The Lasting Impact of COVID-19 on Pharma 

How regulatory changes, technology use and communication form the new normal

This is the final article in the Disruption Series, which has examined the impact of coronavirus on clinical research organizations, pharmaceutical companies and trial participants. 

Speeding up: Regulatory changes to decrease drugs’ time-to-market 

The pace at which COVID-19 cases grew overwhelmed hospitals around the world. As economies ground to a halt, the scientific community worked overtime to explain and reduce virus transmission, manufacture PPE, develop treatments and create a vaccine. 

Typically, vaccines take years to develop—four is the current record. But waiting that long for a vaccine would mean an even higher global death toll. 

In an effort to accelerate the process, agencies like the FDA drastically changed their requirements, reducing the time for trial process reviews. The EMA asked the EU research community to include more member states in trials to increase the amount of data scientist could collect. And it seems like these efforts are paying off.

Speeding up this part of the process, of course, means, other elements had to slow down. 

Slowing down: Delays in regulations 

The MDR changes have been delayed again and again, and the coronavirus pandemic pushed application dates back even further. This time the delay was for a full year. 

Additional clinical guidance documents were released simultaneously with the postponement announcement. Since MDR increases the burden of clinical studies for manufacturers, this delay is vital to companies maintaining forward momentum in a time when clinical trials are suffering from travel restriction and public fear.  

Overcoming distance: Technology applications in clinical trials 

The move from on-site to remote and virtual clinical trials was already partially in motion across the clinical research universe. The pandemic supplied the impetus to expand these efforts, since even study participants allowed travel to sites were less willing to do so

As patients become more accustomed to telemedicine, they expect increased flexibility from providers, including those helping participants through clinical trials. Technology use can offer improved access to instructions that are easier to retain than traditional pamphlets and one-time conversations with medical staff.  

Staying connected: Communications 

Social distancing measures may affect physical distance, but there is no reason they have to reduce non-physical social contact. Consistent and clear conversations with patients and trial participants increase adherence to particular regimen. 

Sometimes, a simple phone call to stay in touch can do the trick. But as people have turned increasingly to social media during the pandemic, the usefulness of social media monitoring has only grown. Pharmacovigilance that includes this sort of “eavesdropping” can form a fuller picture of how a treatment affects a participant.  

The need for good communication extends past the trial period, too. 

Moving forward: Accessibility and Education 

In the post-pandemic world, it is still unclear if telemedicine will continue to be a popular choice for patients, doctors, and insurance companies. But regardless of whether in-person visit return to their normal cadence, making treatment materials accessible to the people actually using them is crucial for best outcomes.  

Readability is paramount when connecting with laypeople. That means a change in the style of writing as well as making sure your communications are in the reader’s native language.  

With improved communication and increased flexibility, CROs and trial sponsors can help participants and patients around the world stay safe, healthy and engaged throughout this pandemic. 

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April M. Crehan
AUTHOR
April M. Crehan