Newsletter | May 3, 2021

05.03.21 -- How IRBs And IBCs Impact Clinical Trial Design

Four Key Elements You Need To Know About The Role Of IBCs In Gene Therapy Trials

The growing gene therapy market presents a multitude of challenges that sponsors, CROs, institutions, and their sites must consider when running clinical trials. To meet these challenges, all stakeholders need to understand the role of not only the institutional review board (IRB), but also the institutional biosafety committee (IBC), in facilitating a safe and effective study. This article shares the four biggest takeaways for drug developers in this booming space.

Interventional Clinical Trial Or Registry Study? Writing Protocols That Demonstrate The Difference

The critical difference between these two study designs is whether the intervention occurs because it is a component of participation in a research protocol, or because a clinical decision was made that the intervention was the appropriate treatment option. Learn how sponsors and investigators can design research protocols that clearly indicate whether the clinical intervention is occurring within, or outside of, the context of the research, and why this distinction is critical in ensuring regulatory compliance.

The IRB’s Perspective: Determining Optimal Compensation For Clinical Trial Participants

Paying participants for the essential role that they play in clinical trials is important, but the amount given, and how it is paid, requires careful consideration. But how can sponsors strike the right balance between compensating research participants to achieve benefits, while minimizing the potential for the payments to have an undue influence on their behavior?

Diagnostics Development Company Relies On Prompt, Personalized Expertise In An Unsettled Environment

During the last year, Toolbox Medical, Inc. has been exceptionally busy, helping clients develop COVID-19-related products. In fact, they launched at least six studies in January 2021 alone. Discover how, as Toolbox’s client base and workload grows, it relies heavily on its long-time institutional review board (IRB) partner for support and solutions.