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In the planning, conduct and reporting of clinical research there was a substantial unmet need.  

Projects that have attracted sufficient grant or other support will be able to work with a formal clinical trials unit.  This will almost certainly improve quality and governance but establishes a threshold financial cost that ultimately limits the 'amount' of research that can be performed.  At earlier stages of career development working with a trials unit can, in some cases, separate researchers from the full learning experience of study delivery.

At the other end of the clinical research spectrum is the interested individual, with enthusiasm, and a laptop.  Clearly this has limitations.

The Improving Clinical Excellence Through the Continuous Assessment of Practice (ICE CAP) unit seeks to bridge this gap.  We at the Liverpool Heart and Chest NHS Foundation Trust have developed a shared resource that provides guidance and a series of practical tools that have allowed clinicians to conduct, often substantial projects with meticulous rigour and oversight, but at a fraction of what might be considered the usual cost.  Our work focuses on important clinical questions in everyday cardiology practice, with an emphasis on comparative effectiveness research. 

We have developed and successfully deployed:

A RedCap instance for the development of online randomisation facilities and the publishing of secure web-based study case record forms;

An electronic Trial Management System (eTMS) for secure and efficient storage and distribution of study folders and other key documentation;

The development of automated (code-based) approaches to the derivation of clinical outcomes and healthcare resources and costs from NHS digital data;

Secure shared file storage and collaboration environment based on Microsoft SharePoint.

Over out first few years of development we have guided seven young researchers to a PhD and have conducted some important, occasionally record-breaking, studies - including:

  • HEAT-PPCI - 1800 patient RCT; Largest ever single centre RCT (Lancet 2014: 384; 1849 - 1858)
  • RIPCORD 2 - 1100 patient RCT; with 17 UK centres  (hotline results at the 2021 European Society of Cardiology: Aug 2021)
  • CRAFT - 400 patient RCT; UK and swiss centres - in progress
  • ARCH - 3000 patient RCT; in progress with > half patient randomised”