Published: 06 April 2018
Good clinical trials are hard work. You need an important research question, money and strategies to recruit enough participants and keep them on board for long enough to get a reliable answer. You have to get everything approved, identify sites, prepare data collection forms and a system to support them, provide training, deal with logistics, the list goes on. But, do all this right, and you could improve the health and wellbeing of vast numbers of future patients.
Given that the raison d'être of the randomised trial is to provide reliable evidence that will inform future choices between the interventions being compared, that hundreds of thousands have been done and tens of thousands are ongoing right now, you might think that there’d be plenty of research to support the choices made for the steps listed in the first paragraph. Sadly, you’d be wrong. There is remarkably little evidence available to support the doing of trials, and trials are much less efficient than they could be as a result.
This is what makes NIHR’s new funding stream for ‘Studies Within A Trial (SWATs)’ in the Health Technology Assessment (HTA) Programme so fabulous. A SWAT is a self-contained research study that is embedded in a host trial in order to evaluate or explore alternative ways of delivering or organising a particular trial process. SWATs can answer questions such as ‘Will 6-monthly newsletters help keep patients in the trial?’, ‘Will face-to-face site initiation visits improve data quality?’, or ‘How much more accurate is it to use specially collected data rather than routine data for follow up?’
These are the sorts of question asked every day in trials, but the evidence to support their answers and the decisions that are made is equivocal at best. There might be as much uncertainty about these issues as there is about differences between the treatments being tested in the trial and a decision one way or the other has consequences. Newsletters do not write themselves. Trial managers might have to spend two days out of the office to set up each site. Funders will have to pay for the special data collection. SWATs can provide the evidence on whether these activities are worth it.
The new NIHR funding makes it possible to build a SWAT costing up to £10,000 into every HTA trial. The approval process is light-touch and there’s guidance on how to design and run SWATs. There are also many ideas already out there, especially for work linked to recruitment, such as the PRioRiTy Top 10 unanswered research questions and the recent update of the Cochrane recruitment review. The SWAT repository can also help because it provides outlines for more than 50 existing SWATs. What would help even more is if SWATs are coordinated, so that we get evidence from several evaluations quickly. This body of evidence can then be used to inform trial process decisions and researchers can move on to other SWATs, rather than have single SWAT evaluations floating around for years but unable to really help decision-making.
There’s also some support available. Trial Forge (email@example.com) can help and so can a group led by David Torgerson and Adwoa Parker at the York Trials Unit (firstname.lastname@example.org). In addition to having done many SWATs, they lead an MRC-funded project on recruitment and retention SWATs in ongoing trials. They can advise on SWATs to build into your new HTA proposal, coordinate with Trial Forge and others, and provide practical advice about how to do the SWAT.
This is a good time for trial process evidence in the UK. This new NIHR funding and several other initiatives are all pushing in the same direction. Although SWATs will not solve all our problems, the results from bundles of them will improve decisions and choices about trial processes. And, once we get into the habit of doing and using SWATs, we’ll wonder how we ever managed without them.