Master protocols, having shown their usefulness in COVID-19 and oncology research, are on the rise and expected to expand into other therapeutic areas. But even with the strong backing of regulators, challenges remain for master protocol studies to become more commonplace. Read More
A new study finds less than one-third of COVID-19 clinical trials are led by female investigators, half the proportion observed in nonCOVID-19 trials. Researchers say the results may indicate a lack of women’s leadership in international clinical trials and new research projects, as well as unequal access for women in research and funding during health emergencies. Read More
Sponsors have combined data from internal and external sources for years, but the pandemic put their data management strategies on steroids, creating a need to gather, process and interpret data in real time to make informed decisions to keep clinical trials up and running. Read More
The pandemic is continuing to disrupt clinical trials in 2021, but the impact varies by therapeutic area, according to data analysis firm GlobalData. Read More
Changes in COVID-19-related research (CIR) submissions surged suddenly in Spring 2020, according to data from the WCG Knowledge Base, as sponsors and researchers quickly adjusted research plans with shifts to virtual study visits, remote measurement of study endpoints and modifications to informed consent processes. Read More
Following through on its statement that it doesn’t expect COVID-19 vaccine sponsors to conduct separate large-scale trials to address variants of the virus, the FDA has outlined additional information the agency needs to amend current Emergency Use Authorizations (EUA). Read More
Minorities and people aged 65 years and older are underrepresented in vaccine clinical trials compared to the U.S. population, but women are overrepresented in such trials, according to a cross-sectional study of hundreds of vaccine trials conducted over the past decade. Read More
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