WCG

Discussion of opportunities on the ethical and regulatory challenges regarding artificial intelligence in clinical trials. The episode is focused through the lens of the IRB review, and how a multi-stakeholder task force led by the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and WCG will address the growing need for guidance in this rapidly evolving area of research.

Institutional Review Boards (IRBs) are critical in the oversight of clinical research and the protection of participants, and with the right expertise, ethical review can result in more efficient, higher quality, more consistent research outcomes. With managing highly complex trials and navigating the changing regulatory landscape, it is increasingly crucial for research professionals to partner with an expert IRB partner.

Early adoption of WCG ClinSphere® eReview Manager provides insight into how a centralized, digital review infrastructure can improve efficiency and transparency across the IRB submission lifecycle. Initial performance data and operational experience indicate measurable gains, including reduced submission entry time, faster review cycles, and significant reductions in document handling effort.

Patient selection can be a nuanced process in clinical trials, particularly those involving therapeutic areas with more complex or subjective inclusion/exclusion criteria. Determining patient eligibility may often depend on factors that require clinical expertise in such areas as disease progression, comorbidities, genetic mutations, and disease severity. Discover the role eligibility adjudication committees play in ensuring trial success.

EACs/CECs evaluate potential adverse events, participants’ safety, whether a patient meets complex eligibility criteria, and much more. Thus, the need to select the right EAC vendor is critical – selecting the wrong partner risks time, money, and success. With so many EAC vendors, it can be challenging to find the ideal partner. Fortunately, WCG has outlined the top five benefits of utilizing an independent EAC.

No clinical trial is successful without careful attention not only to how endpoints are crafted, but how they are reviewed and applied. This article will describe the use of Imaging Core Labs and Endpoint Adjudication Committees (EACs) to increase the quality and accuracy of clinical trial data. Additionally, it will clarify the differences between these critical endpoint review methods and other forms of safety review.

Site augmentation helps expedite COVID-19 vaccine trial by enrolling over 30,000 study participants in just over three months. 

Learn about how sponsors and sites can identify and overcome barriers to participation and implement strategies to diversify their clinical trials.

How are sponsors empowering sites to reach their full potential in 2021?

In the wake of COVID-19, clinical research sites are in dire need of extra resources to help run their clinical trials. By utilizing qualified, experienced WCG Clinical Research Coordinators (CRCs), these professionals can help overburdened study teams get tasks done, and get them done with efficiency and precision.