Enrollment Grows as Clinical Trials Become More Innovative During Pandemic

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After a sharp decline in April, new patient enrollment in clinical trials is now back up to pre-COVID levels, according to recent data from Greenphire, a global leader in financial management for clinical trials.  

The majority of study enrollments had been paused or delayed when the pandemic hit. Of the 150+ sponsors and CROs Greenphire surveyed, 71% paused enrollment and 58% delayed new study starts.  

Considering the clinical trials database currently shows 136,159 studies open, that is a whole lot of people affected.  

In a world of mobile connectivity, most clinical trials were stuck in their analog process of the past, requiring frequent in-person doctor visits often lasting several hours and sometimes scheduled multiple times a week. For many, this makes the burden of trial participation too heavy for a candidate or their family to bear. When faced with mandatory lockdowns, the need for decentralized or hybrid trials became evident. Many trial CROs adapted with virtual visits and local lab support. 

"The industry was hit hard by COVID-19 and at one point, nearly all research came to a stop. It's impressive to see the rebound in patient enrollment and the industry's ability to respond so quickly, in part by leveraging new technologies which promote flexibility of how visits are conducted. We anticipate this trend will continue as 84% of our survey respondents said they are actively seeking to increase their use of tools to better support decentralized trials," said Jim Murphy, chief executive officer at Greenphire. 

Greenphire’s survey showed sponsors and CROs are committed to fostering enhanced relationships with their sites by: 

  • Offering hybrid clinical trial solutions 

  • Providing patient convenience solutions 

  • Streamlining budget negotiations 

  • Increasing site payment frequency 

"The concept of using technology to help create value in a decentralized or hybrid trial environment isn't new per se, but COVID-19 has certainly encouraged wider adoption by forcing everyone to find ways to bring greater connectivity between clinics and patients," said Kyle Cunningham, Greenphire’s chief product officer.  

Michigan mom Jamie Schmitt has first-hand experience with the complications COVID-19 has created for clinical trial participants. Schmitt has two boys living with Primary Hyperoxaluria type 2, a rare disorder affecting the kidneys, currently enrolled in a trial based in Minnesota. Schmitt told BioSpace that due to the cancellation of flights, they’ve had to travel eight hours away once a month to continue their trial participation. Their trial did not adapt to offer any virtual visits, and there are no facilities closer to their home in Michigan. Even now that regular flights have returned, driving feels safer from a germ transmission perspective, but is tiresome and causes her boys to miss more school days and Schmitt more workdays.  

“The importance of the study has pushed us to make the 16-hour round trip to complete. We’re hopeful that the meds are working,” Schmitt said.

Schmitt’s boys do virtual visits with the local specialists they see but their family would greatly benefit from more virtual options for their clinical trial participation as well.  

Some CROs are making strides in adopting telemedicine in some capacity during this pandemic. Kent Thoelke, chief scientific officer at PRA Health Sciences said, “These aren’t your parents’ clinical trials anymore. We’ve virtualized the entire process.”  

Advancing with more practical innovative practices on the logistical side of clinical trials can help not only during a pandemic but ongoing, by creating more accessibility for patients around the globe.

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