The Wellcome Trust, the Gates Foundation and the African Academy of Sciences have come together to form a new initiative to develop new guidelines for clinical research. They point out that ICH-GCP was developed for product registration trials and today is applied much more broadly and this has created a need for new guidelines. The funders want these new guidelines to be based upon scientific evidence, straightforward and simple, adaptable to individual studies and suitable and relevant for the multiple settings and contexts where trials are run (including low- and middle-income countries).

The initiative is currently hiring a scientific lead for the project. MoreTrials very much welcomes this new initiative and will be working closely with it over the coming months.

More information can be found here.

“Basically, if trials are going to be done there are lots and lots of questions that could be answered by trials and should be answered by trials and will not be answered by trials unless we reduce the regulatory burden on trials”

Professor Sir Richard Peto

Introducing the 2018 Archie Cochrane Lecture given by Professor Martin Landray at Green Templeton College, Oxford on 15th March, 2018.

Martin’s lecture, “Re-inventing randomised trials for the 21st century” will be featured here soon

One of the main problems with ICH-GCP is that it has made randomised trials much more complex and costly than they need to be. The result has been an ever increasing cost of doing trials with reports of single phase-3 trials now costing as much as a billion US dollars. This not only prevents the development of many potential new treatments, but makes it much more difficult to properly evaluate many existing treatments and other interventions. Therefore, there is an urgent need to reduce the cost of randomised trials.

[Read more…]

The National Academies of Sciences, Engineering, and Medicine are hosting a series of workshops looking at how real-world data can be converted to reliable real-world evidence to improve patient outcomes. Professor Sir Rory Collins spoke at the recent workshop and argued that rather than placing greater reliance on observational data, it would be much better to make it much easier to do randomised trials properly. You can watch the talk here.

[Read more…]