Clinical Trials Day: Thanking the Unsung Heroes
On Clinical Trials Day, now more than ever, it’s important to recognize and thank those unsung heroes at the focal point of research: research sites and institutions.
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Virtual Symposium: Gene Therapy Research in the Age of COVID-19
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.
Generating Leadership Buy-In for a Clinical Research Business Intelligence Solution
As clinical trials increase in complexity, you gain more value from using each resource at your disposal wisely. Many organizations
Q&A – Ask Advarra Live: The Real-World Impact of COVID-19 on Research
Experts from Advarra and Johns Hopkins University School of Medicine provided practical guidance on the COVID-19 research impact in a recent webinar. We’ve addressed the most popular Q&A topics here.
Empowering Employees Starts with Building a Strong Culture
Now more than ever, people are seeking out employment at organizations that offer more than just standard benefits. They are
Differentiating “Public” and “Private” Internet Spaces in IRB Review
What is the difference between “public” and “private” internet spaces? This question has gained importance with the growing practice of using internet and social media platforms as a source of research data.
How Sites Can Prepare for COVID-19 Genetically Engineered Vaccine Studies
Currently the most prominent coronavirus vaccine candidates contain engineered genetic material. Sites wishing to participate in this research should be prepared for the additional requirements of research involving genetic engineering.
Q&A Part 1 – Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
In a recent webinar, Dr. Luke Gelinas, IRB Chair at Advarra, provided a framework for evaluating offers of payment to research participants. In addition to outlining the challenging ethical and regulatory issues and offering key regulatory guidance, he also provided hypothetical “case studies” to highlight challenging ethical and regulatory aspects of paying research participants. More than 1,000 clinical research professionals joined us for the webinar, which was followed by an engaging Q&A session. Below, Dr. Gelinas answers audience questions we weren’t able to address during the webinar. In the weeks ahead, we will publish part two of his responses, addressing additional questions from webinar attendees.
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.