The global spread of COVID-19 has slowed down and hindered clinical trials throughout the world, Medidata Solutions said Monday based on its recent analysis. According to the report, the COVID-19 pandemic and various “lockdown” measures in place around the world are adversely affecting institutions’ ability to conduct existing trials and initiate new studies.
“The impact of COVID-19 on clinical trials has become an important issue since Aveo Pharmaceuticals cited COVID-19 as the reason for its failed study of Ficlatuzumab for acute myeloid leukemia,” said the technology company that develops and markets software as a service for clinical trials.
Out of the 1,030 respondents engaged in clinical trials, 69.13 percent replied that COVID-19 had affected their ability to conduct existing tests, and 78.29 percent answered the virus affected their ability to initiate new studies.
The company’s global data showed a 74 percent decrease in the average number of new patients entering trials per study year-over-year during the first two weeks of May. In Korea, the number of new patients enrolling in studies declined by 54 percent in May 2020 compared to the same month of 2019.
In response to the pandemic, the majority of test institutes have taken measures to minimize the effect of COVID-19.
Sixty-three percent of the respondents answered that they stopped recruiting new patients in most of their studies, and 45 percent said that they began facilitating virtual and remote medical service. Besides, 43 percent of them postponed trials, 34 percent prolonged period for visiting test facilities, and 33 percent revised their study protocols.
Some institutes also suggested the introduction of telemedicine to address the problem that patients could not visit the test center due to COVID-19.
Problems in financial support were also pointed out as an urgent matter. Due to the nature of the clinical research, it is impossible to adjust the required workforce at test institutes, but they have no practical way to make a profit, the report said.
“Delayed patient enrollment and recruitment, and lack of access to the test center would require alternative remote approaches to replace drug delivery, clinical monitoring, compliance, subject safety, and data quality,” said Kim Hye-ji, senior director of Medidata Solutions Asia-Pacific.
Medidata Solutions (“Medidata”)
Medidata emerged as a leading electronic data capture (EDC) vendor over the last decade—taking the market leadership position from Oracle. Along the way, Medidata either developed or acquired other applications associated with the operations of clinical trials. The company established itself as one of the leading “eClincial” vendors involved with trial planning, trial management, site and patient engagement and reporting and analytics. The market for many of these solutions has become increasingly competitive with not only a number of well-capitalized entrants, such as Veeva, but also the products and services associated with global contract research organizations (CROs) not to mention new disruptive upstarts offering access to open source tools for example.
Dassault Systems Acquisition
Perhaps it was because of the confluence of market forces that led to the Dassault Systems $5.8 billion acquisition of Medidata in 2019. Founded in 1981 as a CAD software firm, they grew to become a global product lifecycle management solution powerhouse. The Medidata acquisition represented Dassault’s biggest-ever purchase. That Dassault would desire such a brand was understandable: Medidata was known for an entrepreneurial spirit and dedication to drive efficiencies in the clinical development value chain. Now Medidata joins Dassault’s mission to transform life sciences by boosting innovation in personalized health coupled with improved industrial performance.
Call to Action: It will take years of analysis to truly grasp the impacts and consequences of COVID-19, but the recent report from Medidata Solutions sheds a light on the important matter. For more updates on the world of clinical trials, follow TrialSite News’ Daily Newsletter.