Sponsors of nonCOVID-19 trials should assess how trial participants receiving COVID-19 vaccinations could impact their studies, according to updated guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Read More
Trials disrupted by the first wave of the COVID-19 pandemic in 2020 are continuing to reopen, but the emergence of two more contagious variants of the SARS-CoV-2 virus resulted in a drop in the rate of recruitment in January, according to data analysis firm GlobalData. Read More
The number of clinical trials focused on COVID-19 has increased 639 percent worldwide to more than 4,000 trials in January 2021, up from 549 in early April 2020. Of those new trials, 762 are being conducted in the U.S., far outpacing other countries, according to a report by marketing research firm GlobalData. China was in a distant second place with 462 trials. Read More
Faced with evolving variants of the SARS-CoV-2 virus, COVID-19 vaccine-makers are considering tweaks to their current products that would call for only small safety-focused trials rather than entirely new phase 3 trials, and the FDA has signaled its approval of that approach. Read More
Individuals who have received one of the COVID-19 vaccines approved for emergency use by the FDA do not need to be excluded from participating in other clinical trials, the agency has said. Read More
RSS
