Applied Clinical Trials-03-01-2011

Partnerships in Clinical Trials

TRIAL DESIGN : Rare Disease Research and Patient Registries Safety: Drug Exposures in Expectant Mothers SUBJECT RECRUITMENT : How to Raise Accrual Rates in Cancer Trials Also in this issue : FDA?s Sentinel System, Clinical Trials Directive, One Hundred Percent Source Data Verification, Understanding Medication Non-Adherence

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

Lessons learned from the recruitment of colorectal cander patients into clinical trials.

The European Union is accepting input regarding changes to the directive until the end of May.

Chinese pharmaceutical company forms alliance with American CRO.

Direction from regulatory agencies would help eradicate wasteful 100 percent source data verification.

FDA's Sentinel Initiative sets pace for tapping e-health records for product assessment.

A 2010 survey conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) finds that sponsor companies are allocating resources, modifying organizational structures, and increasing investment in the development of personalized medicines (i.e., tailoring of medical treatment and healthcare delivery based on individual patient characteristics including genetic, molecular, and imaging).

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Post-approval methods for monitoring the safety of drug exposures in expectant mothers.

News from the Orphan Drug workshop.

The recent shutdown of the R&D facility should signify a warning to the British science community.

A MMG strategic initaitve to address disparities in clinical research participation among Hispanic and Latino communities.

Inappropriate calendar pacakaging is a common occurrence leading to confusion and mistakes.

Researchers are turning to patient registries to fill rare-disease knowledge gaps.