Randomised trials are valuable for the reliable assessment of the benefits and risks of treatments, leading to better care for patients. The absence of such evidence — either because relevant trials have never been performed or because they were poorly designed or conducted — may harm individual patients and public health.
Problem with ICH-GCP guideline
The previous pages have set out the problems with the ICH-GCP guideline, which we believe are twofold, firstly the fundamental problems with the guideline and, secondly, ICH itself. The result of this is that many trials that should get done don’t and those trials that do are more costly and complex than they need to be.
A new Good Clinical Practice guideline is needed that focuses on what is important for the generation of reliable results in randomised trials, while protecting the rights, safety and wellbeing of the trial participants. It will provide flexibility in the choice of methods and technologies used to meet the principles.
Just randomised trials?
No, but we will start by developing a new guideline for doing randomised trials well. This will focus on those few key principles, that if got right, ensure the trial is a good trial. When we’ve done that, we will move on to developing other guidelines for doing other types of clinical research. This will be done in an entirely open and transparent way so anybody can suggest areas that we should focus on.
The new GCP guideline will be developed collaboratively, taking account of the views and perspectives of all those involved in clinical trials, including academic trialists, pharmaceutical and biotech industries, regulators, clinicians, patients and the public. An outline guideline for consideration will be published on this website and modified in response to comments.