It’s 20 years ago already that ICH-GCP (E6)1 was formalised. An internationally accepted Good Clinical Practice guideline was born after about 16 years of national and regional GCP guidelines popping up all over the world. And 2016 marks it’s 20th anniversary!
Looking at how we got to ICH-GCP, the establishing of this guideline is almost deviant from how earlier guidelines and regulations came to be. The clinical research industry being mainly disaster driven
(something bad needs to happen before some regulation or guideline is developed) the ICH guidelines are not a result from any disaster directly.
Of course the development of the first GCP guideline, the US one, incorporated into the Code of Federal Regulation, was disaster driven. It followed the Belmont Report, which was prompted by the Tuskegee Syphilis Study 2.
It took 6 years to write ICH-GCP. Time well spent, if you consider that the outcome was a guideline that has held strong for 20 years. Not a common thing, in this industry. Certainly compared to the Declaration of Helsinki, updated five times in that same time 3.
And after 20 years, it’s time for an update. ICH-E6 (r2) 4is coming later this year. It underlines the strength of the original guideline guideline that the revision only adds things that are current topics.
Basically, the original guideline gets updated to suit current day needs. However there are no changes to the content that we’ve been working with for the past 20 years.
So here’s to you, ICH-GCP, you old E6 buddy! Have a happy anniversary and let’s stay friends for years to come.