Applied Clinical Trials, Oct 1, 2009 - Applied Clinical Trials

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Applied Clinical Trials, Oct 1, 2009
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From the Editor
Put Conflict on the Consent Form?
By Lisa Henderson
What constitutes a conflict of interest for the clinical investigator is what PhRMA is addressing with voluntary guidelines.
News
Globalization Gets An A+
By Kerri Nelen
Recent white paper from ACRO emphasizes the need for global trials.
Global News
Pressure Mounts for ICH GCP Revisions
By Philip Ward
The ICH GCP guideline continues to age and while members of the Institute of Clinical Research voice the need for its revision, industry debates whether changes are necessary.
Special Report
Obesity, Lipids, and Diabetes
By Lisa Henderson
Success and challenges for clinical trials that address these interrelated conditions.
View from Washington
FDA Promotes Integrity and Compliance
By Jill Wechsler
Stiffer enforcement of research standards aims to restore the public's confidence in agency actions.
View from Brussels
Working Toward a Better Future
By Peter O'Donnell
The EU struggles to get over its regulatory hurdles in an effort to further R&D success.
Technology Viewpoint
The Semantics of Health Care Interoperability
By Wayne R. Kubick
Is computer system interoperability for clinical data an impending reality or just a dream?
Feature Article
Late Phase Patient Reported Outcomes
By Murtuza Bharmal , Shilpa Viswanathan
Patient-level feedback from later studies provides a multitude of valuable answers to all stakeholders.
Financial Simulation Modeling
By James R Langabeer II , Jeffrey Helton , Denise M Langabeer
With a PC and some software you can generate realistic projections that save time and money.
Operation Adaptive
By Molly Blake-Michaels
A concise look at this nontraditional approach to clinical studies that explains the how and why of it.
Optimize Your Imaging
By James Paskavitz
Delays and expenses can be spared by crafting plans earlier and more methodically
Community
Business and People Update
By Marissa Shapiro
Industry news focusing on the people and organizations who work in the clinical trials profession
A Closing Thought
A Canary in a Coal Mine?
By David Handelsman
How the ability to apply text mining and signal detection algorithms to social media's real-time data provides unheard of value.

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