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News From Around The Industry

CWWeekly Features

As the Clinical Trials Industry Evolves, the Most Valued Skill Sets for Professionals are Changing

Due to the vast influx of technology and the advent of Risk-Based Monitoring, the clinical research landscape is now evolving fast, and along with it, so are jobs in the field. Denise Snyder, associate dean for clinical research at the Duke Office of Clinical Research (DOCR), says highly specialized skills sets among coordinators is the wave of the future in employment in clinical trials.

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FDA Draft Guidance on Patient Centric Drug Development Focuses on Sampling Methods

Sites and sponsors should have a lot of leeway in determining how to measure patient experiences during drug development, but researchers should take care that whatever sampling methods they provide are a fair representation of that target population, the FDA said in a new draft guidance issued June 12.

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Trial Results & Briefs

NEJM Retracts Five Studies, Revises A Sixth, After Trial Sampling Errors Discovered

The New England Journal of Medicine has retracted five separate papers and reissued a sixth with corrections, nearly a year after an anesthesiologist raised public questions about whether the volunteers in each of the studies had truly been randomly assigned to different treatments.

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GT Biopharma Announces Preliminary Clinical Results From Interim Review of Phase I/II Trial

GT Biopharma announced preliminary clinical data taken from an interim review, or snapshot, of the OXS-1550 Phase I/II trial for patients with relapsed/refractory B-cell lymphoma or leukemia. OXS-1550 is being evaluated in an open-label, two-stage, investigator-led, Phase I/II trial.

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