Applied Clinical Trials-02-01-2010

REGULATORY : Is It Safe to Outsource Safety? Waiving Inclusion/Exclusion Criteria CRO/SPONSOR : Metrics - The Pitfalls of Over Collection SUBJECT RECRUITMENT : Trial Results Provided to Volunteers in Pilot Program Also in this issue : New Reform Law Requires Fee Disclosure, GCP Standards in Global Trials, A Learning Healthcare System, The Physician Payments Sunshine Act

REGULATORY : Avoiding Adverse Event Setbacks in Early Studies TRIAL DESIGN : Proposed Payment Models For the Phase I Volunteer European Pediatric Survey Unveils Research Challenges Also in this issue : FDA Commissioner Wraps Up Her First Year, EU Focuses on Inclusion of Elderly in Trials, Clinical Data Warehouses Stall in Real World, How Pediatric Networks Benefit Children

Adverse events are critical in early phase studies. Early planning can avoid regulatory setbacks.

Proposed "lottery" or deferred payment model aims to resolve undue inducement.

Promising data warehousing systems like Janus are still waiting to realize their potential.

Industry news focusing on the people and organizations who work in the clinical trials profession.

New commissioner seeks to expand FDA's capabilities to bring safe and effective drugs to patients.

Through new pediatric networks, the EU hopes to improve clinical research in children.

Attention turns to its ederly population and their lack of participation in clinical research.

European community weighs in on challenges to pediatric research in this survey from EUCROF.

Updates on cardiovascular drugs in development, including Phase II study results, NDAs, fast-track designations, and related business news.

A look at what the 46th Annual EuroMeeting has in store for attendees.

Why experts predict volatile years ahead for the global cardiovascular drug market.