The ICH plans announced at the start of this year to further revise ICH-GCP – so called “GCP renovation” – set out a strategy to first revise ICH E8, “General considerations for clinical trials” before commencing with a further and more substantial revision of ICH-GCP (E6). This seems like a sensible approach, but given the fact that relatively little is known about E8, in this article I want to look at this guideline more closely.
Most people don’t take part in randomised trials, but those people that do are much more likely to take part in another trial in the future. From talking to trial participants the reasons for wanting to take part in a future trial are varied and include the positive experience of the current trial, wanting to continue to contribute to the development of new treatments and, more generally, placing continued trust in the research and research team.
The MRC/BHF Heart Protection Study was a landmark randomised trial completed in the 1990s that showed the benefits of lowering-cholesterol in over 20,000 individuals at high-risk of vascular disease. The results above show the benefit of cholesterol-lowering with simvastatin for a wide-range of vascular outcomes.
We know that routine breast cancer screening is beneficial in women aged 50-70, but the effects in slightly younger and older women is still uncertain. In response to this, the AgeX trial was established in 2010 offering additional screening to women aged 47-49 and 71-73. Randomisation is by means of clusters to include women invited for screening with their counterparts who are not invited for screening at 65 of the 80 breast cancer screening centres in England.