Despite making up a large percentage of COVID-19 deaths, minorities are not seeing adequate enrollment in clinical trials for potential coronavirus treatments. Read More
Citing a substantially increased volume of requests for expanded access to investigational drugs to treat COVID-19, the FDA has issued a final guidance that clarifies the conditions under which it will consider sponsor and investigator requests for waivers from full IRB review. Read More
Sponsors and sites conducting non-COVID-19 research should use an independent data monitoring committee to determine whether serious adverse events (SAE) are caused by the COVID-19 virus or by the investigational drug before submitting a safety report to the FDA, according to an update to the agency’s guidance on conducting clinical trials during the COVID-19 crisis. Read More
The COVID-19 pandemic has proven a major disruption to the clinical trials industry, forcing the delay of many planned studies and driving drug sponsors and researchers to adapt their study methods so that trials can continue. But many adaptations being used to allow trials to move forward ultimately could yield a more nimble industry that can quickly and effectively respond to clinical trial disruptions. Read More
European industry leaders would like clinical study reports (CSR) on COVID-19 trials to be available on the same day a new treatment is authorized for use, according to a letter to the European Medicines Agency (EMA). Read More
The National Institute for Health Research (NIHR) in the UK has released guidance to support sponsors, investigators, funders, and site research and development directors in their decisions to restart NIHR-supported clinical trials that were delayed or halted because of COVID-19. Read More
Sixty percent of the public surveyed say they believe a treatment or vaccine for COVID-19 will be developed in just under a year. And once developed, 64 percent said they thought it would be less than a year before the public could begin receiving a COVID-19 treatment or vaccine. Read More
The outbreak of COVID-19 had an immediate negative impact on cancer research, causing confusion, trial closings and a need for hasty adaptation to protect its vulnerable patient population, but it’s also ushered in important changes in oncology trials that could have long-term positive effects. Read More
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