By Michael Erman and Carl O’Donnell
(Reuters) – Pharmaceutical companies have ramped up clinical trials in the past month, rebounding from a steep decline in activity following the start of the coronavirus outbreak, though activity remains below pre-pandemic levels, according to new research shared with Reuters.
The research, which was prepared by clinical trial consulting firm Medidata, shows that new subjects entered trials globally in June at a 30% lower rate than they did before the pandemic. But that is significantly higher than the roughly 70% decline in new subject starts in April.
Drugmakers around the world, including Eli Lilly & Co and Galapagos NV have announced plans to delay clinical trials for some drugs because of difficulties recruiting, treating and monitoring patients during the pandemic. In response, regulators, including the U.S. Food and Drug administration, have eased rules around collecting data remotely using digital tools to try to help drugmakers continue to research new treatments.
“Many [drugmakers] are shifting to more remote and statistical ways of monitoring the data that’s coming in,” said Fareed Melhem, a senior vice president at Medidata. “There’s pretty broad acceptance that that should be used to maintain the oversight of the trials.”
Some of the biggest increases in new patient starts for trials were in Europe, with Italy, France and Spain returning to levels of activity roughly on par with where they were before the pandemic, the report said. Germany is around 23% below its pre-pandemic level.
The United States saw the biggest decline in new subjects entering trials in April. Although it has begun to recover, the report anticipates that an increase in COVID-19 cases could affect clinical trial activity in the coming months.
Clinical trials for cancer drugs saw the smallest impact from COVID-19, with new patient starts down 40% at their low point. They have since recovered to roughly pre-pandemic levels.
Trials for cardiovascular drugs suffered the most, with activity dropping as much as 90% in April, but have since made a partial rebound, the report said.
“With an oncology trial it’s a lot harder to tell a patient to wait six months than it is maybe for a blood pressure trial,” Melhem said.
(Reporting by Carl O’Donnell; Editing by Leslie Adler)
