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FEATURED

The Clinical Trial of Tomorrow
Lisa Henderson
In the first of our newly introduced featured theme reports, we explore technology innovation in clinical trials, highlighting the six broad technology themes poised to reshape future R&D, as selected by our panel of experts.

PEER-REVIEWED ARTICLES

Patient-Centric Trial Guide
Hélène L. Svahnqvist, Anna Skabeev
Patient centricity may be a “hot” approach in clinical research at the moment, but there is still much to be done in its practical implementation. Authors present an overview of best practices for clinical trial managers in advancing toward patient-centric studies using today’s clinical trial model.
eCOA and Patient Engagement
Susan M. Dallabrida, PhD
A look at how electronic clinical outcome assessment (eCOA) can improve patient-clinician communication and candor versus traditional paper-based COA, resulting in increased patient reporting of events.
Compliance Hurdles: Auditor’s Perspective
Seema Garg
This report examines the benefits of viewing the operational planning, procedure, data-generation, and timeline challenges of resource- and experience-limited sites from an auditor’s eye.
NEWS

Washington Report: Jill Wechsler on the need to reauthorize drug user fees to support “Cures” implementation.

EU Report: Peter O’Donnell details key changes to Europe’s ethics guideline for clinical research.

Global Report: Philip Ward examines recent scrutiny over investigator financial ties and trial results.

Q&A: Christine Hurley of 4G Clinical discusses the importance of embracing disruptive innovation by having the right business strategies in place.

CLINICAL TRIAL INSIGHTS

Patient Engagement: Dollars and Sense
Ken Getz
With concerns still swirling over the financial value of adopting patient-centric initiatives, two recent studies may help break down those barriers.
CLOSING THOUGHT

Searching for True Innovation
Wayne Kubick
The standards for labeling something “innovative” today are quite liberal. How can our industry find ways to use all its new ideas, tools, and capabilities to generate meaningful disruption?

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issue:
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BLOGS
FDA Refines Inspection Process for Clinical Sites
Improve Patient Comprehension and Retention with eConsent
PDUFA Offers New Tools to Support Drug Development & Review
WEBCAST
Are Local IRBs Really Necessary?
Through metric-generated evidence, find out of if there are significant differences in efficiency and effectiveness between reviews conducted by decentralized (local) and centralized IRBs—and learn the pros and cons of each.

If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - lisa.henderson@ubm.com

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