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COVID-19 Highlighted Master Protocol Benefits, But Challenges Remain

March 22, 2021
Charlie Passut
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

More Than 80 COVID-19 Vaccines in Clinical Trials, Research Shows

March 8, 2021
As of March 1, there were 308 COVID-19 vaccine candidates with 81 in clinical trials, according to a new vaccine trial tracker. Read More

Women Lead Significantly Fewer COVID-19 Trials Than Men

March 8, 2021
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

COVID-19 Update

March 8, 2021
COVID-19 Drug Research Roundup Read More
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Real-Time Data Helped Sponsors Respond to Sites’ Needs During the Pandemic

March 8, 2021
Charlie Passut
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

Survey Shows Ongoing Disruption of Clinical Trials Varies by Therapeutic Area

March 1, 2021
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

CIR Submissions Show Ongoing COVID-19-Driven Trial Adjustments

March 1, 2021
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

FDA Outlines Data Required for Modifying COVID-19 Vaccines Against Viral Variants

March 1, 2021
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

COVID-19 Update

March 1, 2021
COVID-19 Drug Research Roundup Read More

Study Finds Minorities, Older Americans Underrepresented in U.S.-Based Vaccine Trials

February 22, 2021
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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