In our August/September issue:
PEER-REVIEWED ARTICLES
Cross-Company Data Sharing
Claire Sears, PhD, Elisa Cascade, Tammy Klein
With the high cost and data-source issues associated with initiating clinical research sites, authors explore the potential value of cross-company collaboration around data sharing and integration—and the impact on study planning, site selection, site start-up and internal master data management.
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Africa: Fertile mHealth Territory
David Blackman
Africa accounts for about 15% of the world's population, but reportedly hosts only about 0.9% of global clinical trials. With the continent's research capabilities now primed to enable digital trials, this paper proposes an operational framework to support digital- and mHealth-based clinical studies in Africa.
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Reducing Phase III Failures
Alberto Grignolo, PhD, Sy Pretorius, MD
About 50% of "confirmatory" Phase III trials fail to meet efficacy or safety endpoints. Experts examine the reasons why, with clues from recent Phase III failures, and highlight innovative approaches that sponsors are using to help stave off late-stage derailments in product development.
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AE Causality Agreement Gap
Maxim Kosov, MD, PhD, Alexey Maximovich, John Riefler, MD, Eric Batson, Maria Cecilia Dignani, MD, Maxim Belotserkovskiy, MD
Study compares the assessments of 50 adverse drug reactions made by clinical investigators and drug safety experts—in an attempt to measure the influence of subjective judgment on adverse event evaluation.
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NEWS
View From Washington: Jill Wechsler reports on the practical and ethical challenges facing study-design mainstay: the randomized controlled trial.
View From Brussels: Peter O'Donnell dissects EMA's proposed guidance changes for first-in-human trials in Europe.
Global Report: Philip Ward looks at the uncertainty surrounding EMA's relocation post-Brexit vote.
Data Analysis: Survey rates which areas represent true, game-changing innovation in clinical trials.
Patient Recruitment: New precision-driven approaches to matching patients to clinical trials and treatment options.
Clinical Technology: Key industry takeaways from eConsent pilot study.
Patient Engagement: Q&A on lessons learned from patient-centric MS trial.
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CLINICAL TRIAL INSIGHTS
Outsourcing Value Void
Ken Getz
Research spotlights collaboration struggles between sponsors and CROs, and offers two frameworks to fix them. |
CLOSING THOUGHT
Clinical Ops Mission
Jennifer Goldsmith
The time has come to move beyond point solutions in clinical trial operations, in favor of an end-to-end platform approach. |
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