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News From Around The Industry

CWWeekly Features

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

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.

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

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.

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Trial Results & Briefs

FDA Releases Guidances on Clinical Trial Design for Neurological Treatments

The FDA has released five guidances on clinical trial designs and endpoints for developing treatments for a variety of neurological disorders, including Alzheimer’s disease, Duchenne muscular dystrophy (DMD) and ALS.

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Eli Lilly Announces Positive Results for Ankylosing Spondylitis

Eli Lilly announced that Taltz (ixekizumab) met the primary and all key secondary endpoints in COAST-V, a Phase II study evaluating the safety and efficacy of Taltz for the treatment of ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (axSpA). COAST-V is a multicenter, randomized, double-blind, active and placebo-controlled 16-week study.

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