Reviews - Advarra

Patient Engagement and the IRB

Recent years have seen increased efforts to engage with patient and participant communities and include them more closely in research. This approach is reflected in the founding of the Patient Centered Outcomes Research Institute (PCORI) as well as statements from the US Institute of Medicine and Food and Drug Administration (FDA) on the importance of including participant perspectives at every stage of the research process—from the design of studies through their implementation and the dissemination of research results.

Safety Precautions for Laboratory Research With COVID-19 Specimens

The current global pandemic has brought biosafety to the spotlight. Biosafety practices must be customized to the proposed research as well as the existing facility and local regulatory requirements.

Trial Design in the Time of COVID-19: Complex and Efficient

Complex trial designs can eliminate less-promising investigational treatments quickly to speed development, but they remain under-utilized. The current pandemic offers a chance to consider strategies for facilitating adoption of such innovative designs.

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.

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.

Keep in Touch: Tips for Working with a Single IRB for the First Time

Recent regulations and policies have ushered in the era of mandated single IRB (sIRB) review. Many institutions must now establish policies and processes for working with an external sIRB.

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.