Covid-19 has roiled clinical trial plans around the world, raising concerns over the industry’s future on new drug approvals
Over the past 4 months, a group of analysts at GlobalData tracked 322 biopharma companies — biotechs, pharmas, CROs and such — reporting on the trouble Covid-19 has caused for their clinical development plans.
Slightly more than half — 179 — are US operations, with about 1 in 4 scattered throughout Europe and in Canada. And the disruptions are clustered around mid-stage development, though a hefty number of late-stage derailments may well blunt the stream of approvals down the road.
“The majority of disrupted clinical trials are in Phase II, at 44.8%, followed by Phase I with 26.1%, Phase III with 21.7%, and Phase IV with 7.4%,” says Brooke Wilson, associate director, trials intelligence at GlobalData. “Of these trials, 12% are specifically Pivotal/Registrational, giving an indication that there will be an impact on regulatory approvals in the future.”
GlobalData also concluded that:
(T)he majority of disrupted clinical trials — 67.3% — were due to the suspension of enrollment. The delayed initiation of planned trials follows at 18.4%, then, finally, 14.4% of trials are currently being impacted due to slow enrollment. Within the 14.4% of trials affected by slow enrollment, 20.7% of these are specifically due to the availability of sites and investigators.
The big focus now will be how fast the developers can move these delayed trials along, or replace them with fresh efforts. Regulatory groups on both sides of the Atlantic have been helping out with new rules that allow trials to continue, when possible, with home drug delivery and at-home monitoring and the use of telemedicine a more common feature.
Also of note, while we’ve seen plenty of evidence of widespread disruption, a host of biopharma companies have been ramping up new work on drugs and vaccines for Covid-19, striking a whole new set of deals and diverting resources to new programs. So it’s not a zero-sum game.
GlobalData has been tracking more than 700 drugs — from discovery through pivotal programs — linked to Covid-19. “There are now over 2,000 clinical trials globally – 398 of these clinical trials are for chloroquine or hydroxychloroquine and 22 of these trials are for remdesivir,” the company reported a week ago. “There are also over 583 companies and institutions driving prophylactic and curative innovation.”
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