Advarra is excited to introduce Fireside Chats, a series of virtual conversations discussing current issues in clinical trials. Each Fireside Chat brings together perspectives from across the research community, enabling real-time discussion of contemporary challenges and potential solutions to help make research altogether better.
In Advarra’s inaugural virtual symposium, experts from industry and academia met to discuss the unique challenges gene therapy research poses for research sites, sponsors, CROs, and study participants.
In Advarra’s inaugural virtual symposium, industry and academic experts discussed overcoming obstacles and optimizing study startup in gene therapy research. They respond to more popular Q&A topics here.
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.
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.
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.
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.
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.
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.
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.
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.
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.
