The vast majority of health research is conducted with the full informed consent of the people who participate, but in many countries there are specific laws or regulation in place to allow research to be undertaken without consent. Examples include the so called “Common Rule” in the US (CFR 46.116) and “Section 251” support in the UK.
News: Rory Collins (Oxford) The urgent need to streamline randomised trials
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.
News: Rob Califf (Duke) GCP’s mistaken focus on precision at the expense of reliability
Professor Rob Califf, in a recent talk at the National Academies of Sciences, Engineering, and Medicine workshop on “real-world evidence” highlighted the failures of the current healthcare evidence generation system and presented a new approach to conducting randomised trials. You can watch the talk here.
Treatment of childhood cancer in the UK: a learning healthcare system in action
The diagram above outlines a learning healthcare system, which can be defined as an integrated system of delivering health that learns from its own mistakes. The four stages of the learning cycle resemble a traditional learning cycle for, say, an individual learning a new skill (for example, learning to ride a bicycle) and are as follows:
News: Research Waste – Focus on sharing individual patient data distracts from improving trial transparency and also makes it much harder to do randomised trials?
As a result of the AllTrials campaign considerable progress has been made in the last few years to improve trial transparency. This is urgently needed as it is estimated that only around half of the trials that get done go on to be reported.
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