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Read about the effort to review and recommend updates to ICH E3 and to develop clinical study protocol guidance. An open-access article is available online ahead of print at:
http://www.maneyonline.com/doi/full/10.1179/2047480614Z.000000000254

If the link does not respond, please copy and paste the entire link into your web browser search window. The pdf is also available for download from the e-version article.

Please share this OPEN ACCESS PUBLICATION as widely as possible with your professional networks. Thank you in advance for your kind support in helping to disseminate this article.

I am a freelance medical writer providing a range of writing services, primarily to the pharmaceutical industry. I am a post-doctoral virologist working in clinical research since 1994, and specialising in regulatory medical writing from 1999. In my last salaried position (to September 2006), I managed UK Medical Writing for the world’s fifth largest Contract Research Organisation.

I have contributed widely to the official publications (The Write Stuff and Medical Writing [journal]) of the European Medical Writers Association (EMWA). I post my articles on my blog, primarily to disseminate the information to a wider audience, and to hopefully generate some stimulating debate. If you have anything to share, I would love to hear from you.

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Sam Hamilton, PhD.