Trial disruption 'likely to continue,' but 130 trials are now back up and running: report

healthcare worker in protective gear prepares to test a driver in a car at a drive-through COVID testing site
(CVS Health)

There’s a mixed picture on clinical trials right now: While more and more tests are getting back on track after the pandemic delays, the “overall disruption of trials continues to expand.”

This is according to analytics firm GlobalData, which warns clinical trial interruptions due to COVID-19 are “likely to continue” but also points out that trial activity “has slowly started to resume.”

It found there are now more than 130 trials worldwide that are coming back after hitting pause, showing a leveling off from the tough days just a month ago; but it’s a good news-bad news sandwich, as the overall disruption of trials “continues to expand,” says GlobalData.

Revati Tatake, global director at the firm, said: “Although there are relatively fewer trials as compared to suspended trials, the uptick in trials impacted by slow recruitment and delayed initiation is contributing to the continued growth of overall disrupted trials.

“While trial suspensions has appeared to have reached a plateau, this is somewhat deceptive as the overall suspended trial number has not decreased much due to new suspended trials that are being identified.” 

Some biopharma companies, such as Pfizer, have in the last few weeks began to ramp up trial work once again. CROs, however, have been reporting in their first-quarter financials that between 60% and over 80% of their tests have been hit by COVID-19 and lockdown disruptions.

Most have been forced to pull their fiscal-year 2020 guidance, although many see the largest impact now, in the second quarter, but hope to see much of this trailing off and returning to some sort of normalcy by the fourth quarter.

The FDA has previously said CROs and biopharmas will need to find workarounds, including more virtual setups using elements such as telehealth and telemedicine to run tests from decentralized locations.  

Tatake added: “The upward trend for clinical trial disruption may eventually turn around, but it is likely to take time as trial sponsors adjust to the guidance by the FDA, along with a possible shift toward decentralized trials.”