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Blog Entry
Start plain language summaries early or get left behind

In July 2019, the European Union (EU) Clinical Trial Regulation No. 536/2014 will go into effect, requiring all sponsors, including academia, conducting clinical trials to draft a lay or plain-language summary for phase 2-4 clinical trials. These lay summaries need to be published to the new...


Blog Entry
Clinical trial data transparency: the EU inches closer to legal certainty

On 1 March 2017, the Vice-President of the Court of justice issued a ruling that sets up the opportunity for a much needed final adjudication of the parameters of commercially confidential information within clinical trial data. [1] Background To recap briefly on the facts of this case,...


Blog Entry
The Ideal Clinical Trial Patient?

Just when I thought the patient experience and our voice was being considered and respected as a serious partner to the drug industry, I get that reality call to take off the rose colored glasses. This time the splash of cold water to bring me back to my senses came via a tweet from a...