The FDA has issued its Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials to “assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity.” It includes recommendations around evaluating alternative methods for assessments, such as phone contacts or virtual visits, as well as offering additional safety monitoring for trial participants who may no longer have access to investigational product or the investigational site.
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Driving Diversity with the Integrated Research Model
October 16th 2024Ashley 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.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen 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.
Truqap Combination Shines in Phase III Trial for Prostate Cancer
November 26th 2024Data from the CAPItello-281 trial show Truqap alongside abiraterone and androgen deprivation therapy achieved a statistically significant and clinically meaningful improvement in radiographic progression-free survival.
Empowering Sites and Patients: The Impact of Personalized Support in Clinical Trials
November 26th 2024To 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.