Applied Clinical Trials
Tufts CSDD
The 10-year increase in the number of unique and total procedures per protocol corresponds to an increase in the number of endpoints supported by these procedures. Research conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) finds that between 2004 and 2012, the number of endpoints per protocol has nearly doubled from an average of eight per protocol in the earlier period to 14 endpoints in the later period. Half of all procedures support supplemental secondary, tertiary, and exploratory endpoints—a proportion that has remained constant during this eight-year period. Sponsor companies have added more procedures for a variety of reasons: clinical scientists seek more contextual data to interpret and validate findings and guide development decisions; statisticians wish to collect more data to explain observations and potential new interactions; and sponsor companies also note that procedures supporting tertiary and exploratory endpoints are added in anticipation of perceived or real regulatory agency and payor inquiry, commercialization, and competitive pressures.
—Tufts Center for the Study of Drug Development, https://csdd.tufts.edu.
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.