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Revisiting patient diversity in clinical trials… again

Minority groups have historically been excluded from clinical research, an inequity that has led to well-documented public health problems in which therapies tested primarily in Caucasian patients do not work as well in other ethnic and racial groups. This problem is famously exemplified by Sanofi’s blood thinner Plavix, which was approved in 1997 but slapped with a boxed warning in 2010 after researchers realized up to half of Asian and Pacific Islander populations cannot process the drug.

Preparing sites for acquisition

The unprecedented level of M&A activity in the clinical research site sector during the past 24 months has spurred many investigative site owners to consider selling their businesses.

Also in this issue:

• Standard data, extraordinary innovations in clinical trials
• As new EU device regulations phase in, here’s what you should do now
• Regulatory Update
• Month in Review
• FDA Actions
• Study Lead Opportunities
• New Drugs in the Pipeline