COVID-19 - Clinical Trial Impact

COVID-19 has been a disruptive force for all countries, industries and families. Drug development has not been immune, as sponsors, CROs and sites have seen operational and financial disruptions. Like most CROs, Clinipace is assessing data to get a better handle on the impact to current clinical trials. Clinipace has first hand knowledge of the trials managed by us, but a broader data set is always helpful.

A sample of some of the sites, sponsors and CROs with research adversely impacted by COVID-19:

• Yale University in New Haven, Connecticut, has seen clinical trials for cancer cut to “almost zero”.

• Eli Lilly is holding off on starting most new studies for now and hitting pause on the recruitment of new patients into its existing trials.

• A Vantage analysis identifies 315 pivotal trials that, like Lexicon’s Scored and Soloist studies, risk never being completed.

• IQVIA announced that 70 percent of global sites being temporarily inaccessible and a $60 million to $70 million impact to research revenue.

Below are different cuts of data from ClinicalTrials.gov

ClinicalTrials.gov Data

The two charts below speak for themselves. I did a monthly search of suspended trials from January 2019 through March 2020. During 2018, on average 28 clinical trials were suspended monthly. 366 studies were suspended in March 2020 which is almost fourteen times the 2019 monthly average. Amazingly, more clinical trials were suspended in March 2020 than in all of 2019. With a majority of the US and other countries on lock down, suspended studies could increase in April.

Interventional studies make up a the majority of suspended studies, which makes sense as they represent the bulk of clinical trials starts. During the 2019 calendar year, 20,833 interventional studies commenced versus 6,044 observational studies (a roughly 78% vs 22% split).

36% of March 2020 suspended studies were oncology related, which is concerning as oncology patients (and patients of many other debilitating diseases) may not be receiving their drugs or medical oversight. On March 23rd, the FDA Oncology Center of Excellence made a statement regarding patients with cancer during the pandemic and how the FDA plans to help during this challenging period. We know that oncology patients are susceptible to severe complications from COVID19 due to their compromised immune systems. A very unfortunate situation as oncology patients not receiving adequate care could also be at high risk of their cancer progressing.

Industry studies made up 21% of total suspended projects....

Wrapping Up

The above charts demonstrate current industry challenges, however, the drug development industry is quickly innovating to address the challenge. There are currently 306 COVID-19 studies (and growing) listed on ClinicalTrials.gov. Additonally, (per Centerwatch) many parts of trials, including assessments of clinical endpoints, are moving toward a remote design to reduce virus exposure and transmission. The FDA also references the use of telemedicine to proceed clinical trials. While there is uncertainty on when the pandemic will subside (or if we'll get hit with a second wave this fall), CROs large and small are implementing business continuity plans, remote monitoring capabilities and custom novel project solutions. While COVID-19 is having a negative near-term impact on trials, longer-term CRO capabilities will be greatly improved.

Jason Monteleone is CEO of Clinipace & President at Pivotal Financial Consulting, LLC. Clinipace is a global mid-size CRO with operations in the Americas, Europe and Asia-Pac serving small and mid-size pharma and biotech sponsors. Pivotal provides Divestiture Assistance, Acquisition Advisory Services and Strategic Planning to the Pharmaceutical Outsourcing Industry. Jason can be reached at jmonteleone@clinipace.com, jmonteleone@pvtfinance.com. Follow me on Twitter @JMPivotal. Sign up for Jason's latest blogs and updates at www.pivotalfinancialconsulting.com.