Gene therapy research continues its rapid expansion in the clinical setting, especially in infectious disease, rare disease, and oncology. To support discussion of emerging genetic research issues, Advarra presents its first virtual symposium.
Scientific abstracts and articles have reported that 20-50% of studies do not accrue subjects at the site level (1-6). This contributes to a significant amount of waste in clinical research, particularly in the forms of staff time and monetary resources. Such waste can be reduced through the careful selection of clinical trials to activate early in the process, before investing a lot of resources. The protocol feasibility review process achieves this by providing a method to review the logistical aspects of a clinical trial prior to starting the activation process.
Study activation data from the Forte community shows on average, it takes about six months to activate a new, interventional, treatment clinical trial. Long activation periods are not a new trend – in 2008, Dr. David Dilts’ findings showed it took hundreds of steps to activate an NCI-funded trial at a single site. This was just to get the study open to accrual, not to conduct the study. He also found that not all steps added value to the process. To make his point, he charted the study activation process and when he was done, it was 50 feet long by 5 feet tall and in 8-point font! If the clinical development time of a new treatment is to ever decrease, reducing the time in study activation is necessary so actual research can be done.
Research doesn’t just inform medical treatment; it informs public health and public policy, and it helps explain human behaviors.
In this blog we discuss unique issues that research involving emerging infectious diseases like coronavirus can raise for IRB review and research informed consent.
The recent outbreak of the novel 2019 coronavirus in Wuhan, Hubei Province, China, has led to a surge of interest in coronavirus research and concern about the risks associated with coronaviruses. In this blog we introduce coronaviruses and cover strategies for developing medical countermeasures to combat the recent outbreak.
