From Childrens Health Defense Europe: What Could Possibly Go Wrong? British Government & World Economic Forum plan to replace clinical trials with AI projections by John Stone
Five years ago the British Government announced a collaboration with the then little talked about World Economic Forum to research innovative methods of regulation. It is not exactly clear what administrative or financial role the WEF play in this project but in practice the UK Department of Business awards bursaries to research various futuristic concepts. Projects were announced in 2021 and 2022 among the craziest being:
Project led by the Medicines and Healthcare products Regulatory Agency (MHRA)
Project name: Using High-fidelity Synthetic Data as synthetic control arms and to boost sample sizes in clinical trials
Project grant: £750,387
Project overview
Clinical trials are a critical part of how new medicines are tested before use in the NHS to improve patient care and wellbeing. In standard clinical trials, patients are either given a treatment or not by random selection. This can be challenging in some health conditions, as random assignment to a control group could deny patients access to treatments that could extend their life or improve symptoms. Many clinical trials also find it difficult to recruit enough patients, particularly those investigating rare diseases.
Recent improvements in computing power have allowed researchers to create artificial patients, with similar health information to real patients in clinical trials. This artificial data could help to ‘boost’ smaller clinical trials, lessening the number of patients needed to be successful. Artificially generated information could also be used to better reflect groups in society that are less well represented in clinical trials, including different age groups and ethnicities.
This project will focus on the use of computer-generated data to help boost small clinical trials, and to see if this can improve the value of these trials. Following this, we will create an entirely artificial control group for a clinical trial. In the future, these approaches could be combined with, or even replace, real patient information. Success in this project could help to change the way clinical trials are performed in common and rare diseases, lowering their cost and improving how new treatments are tested before they are applied in the NHS.
Jeremy Hunt, the U.K.’s chancellor of the Exchequer, said during a Thursday panel discussion.. that “when we have the next pandemic, we don’t want to have to wait a year before we get the vaccine. If AI can shrink the time it takes to get that vaccine to a month, then that is a massive step forward for humanity,” Hunt said.
Against a background where the WEF, WHO and the British government propose to have a new “vaccine” ready within 100 days of their expected new pandemic this is presumably how they would model the safety and effectiveness of a product with few or no trial participants. Weep.
Circumstances for informed consent in the future need to include info if a clinical trial used real patient groups or AI data generated by artificial patients.
Learn more about strengthening the circumstances on informed consent in Europe. The Trust and Freedom EU Citizen initiative petition for informed consent and citizen empowerment.
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