Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
In this blog, we’ll take a look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”
Advarra
Reporting to the IRB: Investigator Noncompliance
We often get questions about exactly what events should be reported to the IRB. We understand that “reportable events” can be tricky: some “events” are specifically referenced in the regulations, but lack a definition; some are covered in regulatory guidance documents; and some are “industry standard” that are neither an IRB regulation or IRB best practice/guidance. In this blog, we’ll look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”
Your Guide to sIRB Mandates
In the past few years, new regulations and policies have been announced and implemented to address the challenges of conducting clinical trials involving multiple research sites. Chief among these requirements is the use of a designated sIRB for multisite research.
Protocol Feasibility to Promote Trial Efficiency
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: A Complex Process That Doesn’t Have to Be Painful
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.
How Research Informs the COVID-19 Response
Research doesn’t just inform medical treatment; it informs public health and public policy, and it helps explain human behaviors.
IRB Review of Coronavirus and Other Emerging Infectious Disease Research: Issues to Consider
In this blog we discuss unique issues that research involving emerging infectious diseases like coronavirus can raise for IRB review and research informed consent.
Are “Virtual Trials” Mainstream Yet?
While some completely virtual trials are taking place, the real trend involves bringing virtual trial components to traditional study designs to improve study efficiency and reduce participant burden.
Key Biosafety Considerations for Coronavirus Research
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.
Revised Common Rule Compliance Now in Full Effect—and What That Means
After multiple delays, exceptions, and oh-so-many training sessions, on January 20, 2020, we reached the last remaining compliance milestone for the final revisions to the Federal Policy for the Protection of Human Subjects (“revised Common Rule”).
Beyond the Regulations: More Considerations for Emergency Research
In this blog post we go beyond the regulatory requirements and examine three other key actions that research organizations may want to consider before conducting planned emergency research at their facilities.
Most Popular Blogs of 2019
As we near the end of 2019, let’s take a look back at the blogs that generated the most interest this year from readers like you.