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News From Around The Industry

CWWeekly Features

National Academies Workshop Suggests Principles for Use of Real-World Evidencehttps

Experts convened at the National Academies of Sciences, Engineering and Medicine to examine how the uptake of real-world evidence will impact medical product development, recommending producers and consumers of evidence focus on maintaining transparency, accountability and reproducibility of results.

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

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.

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CTTI Investigates Barriers to Conducting Pediatric Antibacterial Clinical Trials

Pediatric antibacterial drug trials currently account for less than one percent of all interventional and observational pediatric studies registered on between October 2007 and September 2015, or only 82 out of 12,703.

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Trial Results & Briefs

EMA Revises Guidance on Biomarkers for Alzheimer’s Therapies

The EMA’s Committee for Medicinal Products for Human Use revised its guideline on the clinical investigation of treatments for Alzheimer’s disease, focusing on the design and analysis of safety studies and the potential use of biomarkers in various stages of development.

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Bioverativ Announces First Patient Dosed in Study for Treatment of Cold Agglutinin Disease

Bioverativ announced that the first patient has been dosed in the Phase III clinical program of its investigational therapy BIVV009 for cold agglutinin disease (CAgD). The Phase III program includes two parallel Phase III trials, Cardinal and Cadenza, which are evaluating the efficacy and safety of BIVV009 in adult patients with primary CAgD, a disease with no approved therapies.

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