As previously discussed, the concept of Quality by Design is a proactive process to identify the errors that matter when doing a randomised trial. This is in contrast to ICH-GCP which focuses considerable time and effort through data checking to ensuring all data are error free. ICH-GCP regards all errors as important, whereas QbD sets out to identify which errors matter when doing a trial and which are not important.
“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.
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.