- Pfizer on Tuesday said it is beginning to restart clinical trial enrollment that had been paused in March to allow hospitals to prioritize patients with COVID-19, a potential sign the expected disruption to drug development from the pandemic may be more temporary than initially assumed.
- Recruitment will resume at sites ready to monitor patient safety and where health authorities are allowing work with experimental drugs to proceed. Pfizer said it's working with sites to collect data without having enrollees enter healthcare facilities and potentially be exposed to the new coronavirus.
- More than 70 companies of all sizes across the biopharma industry announced delays or other changes to their trials in response to COVID-19, affecting more than 200 studies across all phases of development.
With hundreds of trials potentially delayed or disrupted, the pace of drug development and approvals could slow. This could result in yet another impact of the coronavirus pandemic, particularly as the biopharma sector relies on a steady pace of clinical progress to raise money, offset aging products and build new business.
In March, Pfizer had announced a three-week trial enrollment pause in all countries outside of China, South Korea and Japan, although it continued work on experimental drugs for life-threatening conditions.
The rationale, shared by other drugmakers, was that healthcare facilities would have limited resources to recruit, enroll and monitor new clinical trial patients, particularly as the burdens imposed by COVID-19's spread grew.
Alongside announcing first-quarter earnings, Pfizer said enrollment has resumed at currently operational sites where trial activities are allowed by government and where investigators have the capacity to monitor patient safety. That includes new trials as well as ones already underway when Pfizer first announced the pause.
The company said it wants to help sites to expand tele-health and home health capacity to enable remote data collection.
Nonetheless, the weeks-long disruption means completion of trials "currently in the recruitment stage or studies that have yet to begin could be delayed," according to the company's statement.
Pfizer wasn't alone among its big pharma peers in making the difficult decision to delay work on experimental drugs. Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck & Co., Novartis, Roche and Sanofi all made similar announcements.
Some had limited impact on only specific trials, while others paused work across their pipelines.