This is a personal perspective on what I think is one of the fundamental problems with the whole paradigm of how we regulate randomised trials. This is the mindless following of instructions rather than thinking about what matters to do a trial well.
Fundamental problems with ICH-GCP: #4 “A camel is a racehorse designed by a committee”
My colleague Trudie Lang is the nearest thing I know to a superhero. Bounding with energy and enthusiasm, which is something of a necessity as she does trials in some of the poorest places around the world and frequently does that research in the eye of the storm of a major disease outbreak. First Ebola and now Zika have taken up most of her time so that if you try to find her in Oxford she probably won’t be there. She is one of the driving forces behind MoreTrials.
Association of the Scientific Medical Societies in Germany (AWMF) joins MoreTrials
AWMF (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften) founded in 1962 and the umbrella organisation for 174 German medical and scientific societies has joined the MoreTrials campaign.
Is the door to ICH opening?
Maybe, read on…………
The MoreTrials campaign has one goal to replace ICH-GCP with a modern set of principles of how to do trials well and which is developed by involving everybody in the trial community.
Contrast this with where we are now and the reason for starting this campaign at the beginning of this year.
Fundamental problems with ICH-GCP: #3 is GCP training any good?
The success or not of a trial ultimately depends upon two key groups: The participants who take part and the clinic staff that take care of them, so training these staff well really matters.