Providing an evidence base for trial conduct best practice

Momentum gained through innovative trial design may be lost if trial conduct is sub-optimal. Our research aims to provide an evidence base for trial conduct best practice by developing and evaluating methods to ensure that trials are run effectively and efficiently. Similarly, momentum may be lost by inefficient or poorly presented evidence synthesis. Hence, the Unit also focusses on best practice in the conduct of systematic review and meta-analysis.

 

Trial Monitoring and Data Quality

Reliable trial results can only be obtained with data of appropriate quality. Ensuring and demonstrating data quality is time-consuming and accounts for a large proportion of trial costs. Surprisingly, there are no internationally-agreed standard methods for best ensuring quality data, or for implementing monitoring.

 

Electronic Health Records (EHR)

Recognizing the potential that timely access to appropriately linked EHR has to provide cost-effective data for trials, the MRC CTU at UCL successfully bid to the Government’s new Health Data Research UK (HDR UK) body. Under the theme of “21st Century Clinical Trials”, the MRC CTU at UCL will work with six London universities to unlock the potential of EHRs to deliver better, cheaper and quicker trials.

 

Regulatory future-proofing

Typically, industry-sponsored phase III trials are orders of magnitude more expensive than equivalent 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 low 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.

 

Implementation of novel designs

We have been pivotal in developing novel designs, notably multi-arm multi-stage and platform, umbrella and basket protocols. We continue to share our experiences at the national and international level. In particular, novel designs provoke new practical problems that traditional trials do not experience, including longevity of committees and multiple competing demands on staff time.

 

Timely and reliable systematic reviews

We have developed a novel Framework for Adaptive Meta-analysis (FAME) in which the objectives, eligibility criteria, outcomes and analyses for a particular review are defined prior to all (or the large majority of) trial results being available; thus lending the approach a level of rigour akin to a prospective trial. Working closely with trialists, we develop a detailed picture of how trial results are likely to emerge over time, allowing us to anticipate the earliest opportunity for reliable meta-analysis.