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2021 Update

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Researchers question design of fatal French clinical trial

www.nature.com

January 28, 2016
Clinical development, International

Scientists are voicing concerns over the design of a French drug trial that left one participant dead and several others with severe health problems — and they are calling for more information to be released. The researchers, including those in the UK’s Royal Statistical Society (RSS), have examined a document that describes how the trial was conducted, and say that major pieces of information are still missing.

Scientists speculate on what caused the Bial drug testing tragedy

www.forbes.com

January 28, 2016
Clinical development, International
  1. Few details, best informed speculation
  2. Drug is an irreversible FAAH inhibitor
  3. “Off-target” effects
  4. Other possibilities: Drug impurities?
  5. Other questions: Why did the study have a placebo group?

Africa’s pharm industry booming, but dire shortage of clinical research specialists

agenda.weforum.org

November 24, 2015
Employment, International

Why does Africa need more pharmaceutical professionals? Africa’s pharmaceutical industry is one of the world’s fastest growing…Despite the boom, the continent’s pharmaceutical industry faces several challenges that will stifle its growth. Africa has a dire shortage of specialists to conduct clinical research and develop novel medicines to tackle diseases on the continent. (World Economic Forum. Published in collaboration with Quartz Africa)

New regulation will drive EU clinical trials, but are you ready for it?

www.outsourcing-pharma.com

November 22, 2015
International, Regulatory

The new EU clinical trial regulation will overhaul the sector according to SynteractHCR, but are CROs prepared for the extra resources and tighter deadlines it will produce?

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