Nextrials Meets with CDER Healthcare IT Group
At the invitation of the FDA, Nextrials recently demonstrated to members how the integration capabilities of its Prism® clinical data and trial management platform could improve data collection and drug safety reporting.
At the invitation of the FDA, Nextrials recently demonstrated to members how the integration capabilities of its Prism® clinical data and trial management platform could improve data collection and drug safety reporting. Using its electronic health record (EHR) integration tool, E2E™, Nextrials staged a live demonstration for the Center for Drug Evaluation and Research (CDER) Healthcare IT Group and authors of the FDA's eSource Guidance.
This demonstration enabled attendees to examine how the integration of electronic data collection (EDC) in clinical trials with individual patient EHRs could not only provide benefits from a regulatory perspective, but also could boost patient care from the standpoint of healthcare providers. Nextrials also met with authors of the FDA eSource Guidance. The eSource Guidance provides recommendations for the use of electronic source data in FDA-regulated clinical investigations. The application of this guidance was discussed from the perspective of sponsors, patients, e-clinical software vendors and treating physicians.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
Optimizing Phase III Oncology Trial Recruitment with Data-Driven Insights
February 3rd 2025A pharmaceutical company aimed to launch a Phase III clinical trial for a new oncology drug, focusing on efficient and effective patient recruitment across diverse regions. They evaluated patient populations by analyzing demographics, social determinants of health, and geography. Investigator profiling included practice details, affiliations, referral networks, and clinical trial experience. The final step involved selecting and extracting target lists for implementation.
