Features

Tufts CSDD: Clinical Trial Startup Process Takes Longer Than 10 Years Ago

March 12, 2018

The process of selecting clinical trial sites and launching studies, beginning with site identification and ending with study start-up completion, takes an average of 31.4 weeks for Phase II and III studies — a full month longer than the average seen 10 years ago, according to a survey conducted by the Tufts Center for the Study of Drug Development.

Free Online Transparency Tool Tracks Clinical Trials Reporting Compliance

March 5, 2018

The FDAAA TrialsTracker, an online tool that charts whether individual sponsors report their study results on ClinicalTrials.gov in compliance with federal laws and regulations, launched Feb. 19. The data transparency project was developed by the University of Oxford’s Evidence-Based Medicine DataLab, and is available to the public.

Early Chart Reviews Can Provide Steady Flow of Potential Study Subjects, Experts Say

February 26, 2018

Beginning chart reviews before initiating a site can generate a list of prequalified candidates for outreach — and give sponsors the chance to examine the study’s inclusion and exclusion criteria, and their potential to cause enrollment issues, according to experts during two WCG webinars on acceptable methods for sites and sponsors, and best recruitment practices.

Sensors and Wearables Transform Clinical Trials but Challenges Remain, Experts Say

February 19, 2018

With a multitude of sensors, wearables and mobile devices becoming available for use in clinical trials, sponsors should conduct systematic comparisons before designing protocols, according to experts at the annual SCOPE conference, who presented the work they’ve done to demonstrate the value of using digital monitoring in their studies, as well as the obstacles they encountered.

SCOPE 2018: Advances in Big Data, Patient Centricity Could Shift Sponsor, CRO Relationships

February 19, 2018

At the annual SCOPE conference in Orlando, Fla., clinical trials experts agreed that the traditional relationship between contract research organizations (CROs) and sponsors is evolving, alongside accelerated pursuits in big data and patient centricity — with more CROs expected to share in the risks of drug development as more of a partner than a vendor.