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.
Last time we covered the INFANT trial which demonstrated no apparent benefit for “high-tech” decision support software used during childbirth. This week we look at the other end of the technology spectrum during childbirth by way of the BUMPES trial to answer the question does lying down or sitting upright during the second stage of labour with a low-dose epidural make a difference to the number of women having a normal vaginal birth?
When we think of large simple randomised trials we might think of maybe studies done in cardiovascular disease or cancer and testing one or more drug treatments. But the need for reliable evidence from large randomised trials extends across all areas of medicine and trialists have applied themselves in many areas to develop this evidence. One such area is pregnancy and childbirth.
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.
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.