REMS Operational Challenges: Considerations in REMS Development and Long-term Management

The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.

Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.

Results from a followup evaluation of COLOFOL trial show no significant improvement in 10-year overall or colorectal cancer–specific mortality rates between high-frequency and low-frequency postoperative follow-up regimens for patients with stage II or III colorectal cancer.

Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.

Modern clinical trials are more complex than ever, and one significant reason is the increased focus on patient engagement. Incorporating a patient engagement platform into your clinical trial enhances the patient experience and can lead to more successful trials with stronger, more reliable outcomes. We put together this helpful checklist of key features to look out for when choosing a platform for your study.

Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.