Action Items

The changing landscape of clinical trials in Asia and the Pacific Rim

Tuesday, December 1, 2015

In recent years, the clinical trial landscape in Asia and the Pacific Rim has evolved faster than in most other regions. More than half of the world’s population lives in this rapidly developing area, which includes advanced economies such as Australia, Singapore and South Korea, as well as countries with vast populations like India and China.

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Consortium hopes to make clinical trials more diverse

Sunday, November 15, 2015

Second of two parts

Over the past 20 years, the com­bined efforts of Congress, along with the offices of women’s health at FDA and NIH, have increased the participation of women in clinical tri­als. Minorities, however, still account for less than 5% of clinical trial partici­pants. In fact, minorities “are not hard to reach; they are hardly reached” (Lu Chen, HealthDay News, March 2014).

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Five steps to a smooth IRT vendor transition

Sunday, November 1, 2015

According to a 2015 market research report, the global clinical development outsourcing market will top $64 billion by 2020, with CROs managing nearly 72% of all clinical trials. As the outsourced model grows, sponsor-vendor relationships will play a much larger role in trial success.

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FDA expedites drug/biologic development and approval

Thursday, October 15, 2015

The FDA has created four mecha­nisms to expedite development and approval of drugs and biologics that effectively treat serious diseases: Accelerated Approval, Breakthrough Therapy Designation, Priority Review and Fast Track Designation. Under­standing the requirements and ben­efits of each can inform decisions for your development program.

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Group seeks greater diversity in clinical research

Thursday, October 1, 2015

First of two parts

In 2006, a trial led to a “black box warning label” for an asthma medi­cation found to have a disproportion­ally increased death rate. It revealed that respiratory-related deaths oc­curred four times more often in Af­rican-Americans who took the drug.

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Biosimulation takes center stage in determining pediatric dosing during clinical trial process

Saturday, August 15, 2015

Biosimulation is playing a growing role in drug development, espe­cially with candidate drugs intended to treat pediatric populations. Re­searchers want to minimize children’s exposure to experimental drugs. Therefore, they increasingly are turn­ing to physiologically-based phar­macokinetic (PBPK) modeling and biosimulation to provide insights into how a candidate drug might behave in younger subjects.

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