Providing an evidence base for trial conduct best practice
Clinical trials help doctors and patients to make better healthcare decisions. The way that a trial is conducted and its data collected and checked affects the confidence we can have in its results, as well as the cost of running the trial. Unfortunately, many of the approaches that are used to run trials are not based on high-quality evidence, and in some cases there is little evidence at all for best practice. We aim to plug gaps in the evidence and to find better ways of running trials. We are also looking at ways we can make trials more cost-effective as they can be very expensive.
Using routinely-collected health data (EHR) for clinical trials
Timely and reliable access to electronic health records (or “routinely-collected health data”) has the potential to transform the conduct of many clinical trials, making them considerably more cost-effective. We are developing evidence on how useful and accessible such data is, by collecting researchers’ experiences with its use and working to improve the systems.
We are seeking to develop guidelines for the use of electronic health records in trials. This work is in partnership with NHS Digital, and together with Heath Data Research UK, and the NIHR-MRC Trials Methodology Research Partnership Health Informatics for Trials Working Group.
Improving communication of trial results
Clearer communication of trial results will increase impact, improve research transparency, and reduce waste. We are studying how to better provide findings and results to participants and clinicians. For example, Show-RESPECT is assessing how to give results to participants and KMunicate showed better ways to express time-to-event data in graphs.
Practical implementation of new trial designs
We have been pivotal in developing novel designs, notably multi-arm multi-stage and platform, umbrella and basket protocols. We are keen to share our experiences, nationally and internationally, using case studies to show where the use of novel designs has been successful, and providing solutions to any challenges they present.
High-quality monitoring of trial data is essential for patient safety and trial integrity, both of which rely on data of sufficient quality. This is a key issue in trial delivery, but has been under-researched.
We are developing a monitoring toolkit to provide resources and a more structured approach to monitoring for researchers. We have established a national UKCRN Task and Finish Group in this area to improve the evidence-base for future trials.
Ensuring academic RCTs can be successfully used by regulators and payers
Typically, industry-sponsored phase III trials are orders of magnitude more expensive to run than academically-sponsored trials. As industry cannot undertake all the trials in which their product may improve outcomes, academic trials must fill this gap; efficiently meeting regulatory needs at lower cost. Our work in this area has the potential to make the UK a more attractive place for industry, particularly in terms of academically-initiated trials.
Sharing data from clinical trials
Transparent and FAIR sharing of clinical trial data for further research is important and the strengths and challenges are increasingly recognised. We have been involved in setting standards and are now developing a new approach to requests to the MRC CTU at UCL.