Salvaging clinical trials in the time of Covid-19

To date, more than 1,000 clinical trials have been disrupted due to the Covid-19 pandemic, according to GlobalData’s pharma intelligence centre. 

As clinical trials are the pharma industry’s bread and butter, the lack of new, innovative treatments being studied and coming to market could have a severe impact on patients, as well as long-term impact on companies’ revenue.     

Unfortunately, this situation has worsened as the pandemic has continued to wreak havoc and drive more uncertainty for global economies – “the total number of disrupted clinical trials has more than doubled since April 15” notes Brooke Wilson, associate director of trials intelligence at GlobalData. 

Despite this upward trend, there is a glimmer of hope that the tide is turning for the clinical trial landscape; Wilson explains: “there are now 90 trials, previously disrupted by the Covid-19 pandemic, [which] are now ongoing or completed.” Begging the question, how is the industry starting to salvage some of their clinical trials in response to pandemic?

The majority of clinical trials, 67.6%, were disrupted due to suspension of enrolment, while 18.8% have been impacted by slow enrolment and 13.6% due to delayed initiation, according to GlobalData figures. Life sciences technology vendor Medidata’s survey of clinical trial sites had similar results; it found that sites were most concerned about the ability to enrol and recruit patients, as well as patient access to the site. 

A central issue is that, “many hospitals that serve as trial sites are being inundated with Covid-19 patients, [meaning the site] is no longer available,” notes Wilson. “For that same reason, many investigators may be repurposed to Covid-19 drug discovery trials or treating Covid-19 patients, [so] activation of sites for non-Covid-19 trials may be deprioritised.”

Further to this, lockdowns - a result of the Covid-19 pandemic - are preventing visits to clinical research sites. Another technology vendor focused on life sciences Veeva vice-president of site strategy Bree Burks explains: “Research patients are not visiting research centres due to health concerns – with no patients, there’s no research.” 

Medidata senior vice-president of professional services Pete Buckman notes that getting patients to clinical research sites has been trials’ biggest challenge in the pandemic.

Building on Burk’s point, Wilson adds that those enrolled in clinical trials often have severe health conditions that significantly affect their immune system, meaning they are more at risk of contracting Covid-19. 

Focusing on oncology trials, the therapeutic area with the highest number of disrupted trials, according to GlobalData, Vigeo Therapeutics CEO and president Dr Jing Watnick adds: “Cancer patients themselves are frightened and know they may be uniquely susceptible to more severe complications.” 

This leads them to delay treatment or clinical trial enrolment, risking, “progression of disease in patient who have exhausted all approved treatments”, as well as “potential organ failure and death.” 

“At this time, it’s critical that we, as an industry, do not forget about the millions of people dealing with the devastating disease of cancer,” Watnick explains. “Their struggle is not put on hold due to the pandemic, so our fight to help them should not be put on hold either.” Importantly, this message is applicable to all disease areas with at-need patients.

GlobalData’s analysis into clinical trial disruption suggests that although the pandemic is affecting the entire industry, smaller companies are being disproportionately affected - those defined as small, micro and nano, since they are worth less than $2bn, make up 71.1% of all companies affected. 

Clinical development artificial intelligence analytics company Phesi founder and president Dr Gen Li notes that, consequently, the profitability of smaller companies will be more impacted, and having to cancel their trials may be “a death sentence for those companies”. 

“This would be extremely unfortunate because so many innovations for our industry come from smaller companies”. 

According to Wilson, disruption to trials will have: “An impact on regulatory approvals in the future.” This is because 12.9% of the disrupted trials are pivotal or registrational and 43.7% and 24.4% respectively are Phase II and Phase III studies. Medidata’s survey of trial sites also suggested financial implications of disruption was of serious concern, with a particular focus on cancelling trials and delayed milestones. 

“In order for clinical trials to achieve their endpoints during Covid-19, companies will have to adapt to disruptions and reprioritize their goals,” concluded Wilson in a statement. 

A central way the industry is adapting and salvaging their trials in the pandemic is to embrace virtualised trials; Medidata’s survey found 45% of respondents had switched to virtual or telemedicine for their trials. “This situation has forced the industry into the opportunity to maximise the value of technology in conducting clinical trials,” notes Li. 

Medidata and Veeva both note that their customers are seeking to find out how to virtualise their trials using the vendors’ technology, including Rave Patient Portal and Veeva SiteVault Free. Talking about her company’s experience specifically, Watnick notes the “we have continued virtually with uninterrupted contact and responsiveness to all of our active sites to help them” with the continued running of trials. 

Switching to virtual site visits and allowing for remote patient monitoring prevents delaying or halting of trials “met with subject quarantine and travel limitations and clinical site closures,” Wilson notes. Burks explains that remote patient monitoring allows pharma companies to work virtual with “sites for source document review and verification, a key process that is typically done in-person and important to keeping trials on track and closing studies.” 

Since theregulators – and particularly the US Food and Drug Administration - have been very supportive and accommodating of the industry adapting to virtual trials, could this pandemic transform how clinical trials’ resilience after the pandemic comes to an end? 

Li is very optimistic that the pandemic will push the industry to do things previously unthinkable to drive efficiencies in clinical development. He focuses on the promise of virtual placebo groups or synthetic control arms as a future innovation that utilises technology to the benefit of pharma’s speed and cost effectiveness.

Burks agrees, stating: “Out of this, companies will find new ways to more effectively and efficiently run their trials with advanced digital applications. This will leave the industry in a much better position to keep their important research going, without disruption.” 

“We will never be in a situation where all trials are completely virtual, but I do believe this current situation will challenge pharma companies to assess how much they do on site with patients,” Buckman concludes. “Technology can play a big part here and the current Covid issue will only help push companies in that direction.”