ICH have just announced their plans to modernise ICH-GCP and related trials guidelines. This is welcome news and comes on the back of the announcement at the end of last year to adopt the recommendations proposed by us to the finalised addendum to ICH-GCP (E6). The reflection paper, which calls for a “renovation” of ICH-GCP is available for comment until 11th March.
MoreTrials will be responding and we will publish our response here.
The paper from ICH also acknowledges publicly for the time the existence of the MoreTrials campaign. The second paragraph states:
ICH believes that the proposals outlined in this reflection paper would largely address concerns recently expressed by some research organizations and an international consortium of health researchers.
With a footnote to our original letter to the EMA and ICH.
This acknowledgement is important because we started this campaign to make it much easier to do better randomised trials by first fixing two long-standing and related problems. The first one was the document ICH-GCP and the second one was ICH itself.
Our argument was that trials are not just the concern of just drug regulators and industry. The reality until the end of last year was that ICH-GCP had never been updated since it was first created back in 1996 and second ICH ignored requests for discussion and dialogue. All that looks like it is beginning to change.
That said, I created the cartoon at the top of the page a while back to try to make the point that we created MoreTrials on the back of the success of the AllTrials campaign (and to remind me that to be successful MoreTrials will need to be a public campaign).
When I first mentioned the idea for MoreTrials to Iain Chalmers his immediate response was, “fabulous idea, go and meet with Tracey Brown and Sile Lane from Sense About Science.” I didn’t know it then and many don’t know it now, but Sense About Science are the driving force, the brains behind AllTrials.
While the changes to ICH-GCP, the start of a dialogue with ICH and regulators are all welcome and will continue, the bigger goal of this campaign is to change the story about research. From one where the default response is “oh, that trial must be really risky we better protect people.” To stop kidding ourselves that we inhabit anything that looks like a “learning healthcare system” or that “real-world data” will be the game changer.
We need a new story. Sense About Science will write that new story for us.