Stephen Senn

WINREVAIR (sotatercept-csrk) met the study’s primary endpoint of time to first morbidity or mortality event.

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.

To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.

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.

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.

Multilayered strategies such as working with patient advocacy organizations and leveraging technology can help industry better partner with patients.