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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
This monthly feature presents a variety of questions from clinical trial professionals with answers from WCG Clinical’s expert staff. This issue features advice from Patience Stevens, vice chairperson at WCG Copernicus Group IRB, and Lindsay Abraham, regulatory lead for IRB chairs at WCG Western IRB (WIRB). 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
Sponsors, investigators and patient advocates have a chance to weigh in on the FDA’s development of a network to support the conduct of clinical trials in rare disease populations. Read More
Sites and investigators struggling with obtaining informed consent from patients in quarantine or in the hospital can use the FDA’s free COVID MyStudies app. The app sends a consent form electronically to the patient for signature. The site then can access the signed consent through a secure portal and either print or transfer it electronically. 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
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
