Clinical Trial Performance Data

The Government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical research. The aim is to increase the number of patients who have the opportunity to participate in research and to enhance the nation’s attractiveness as a host for research.  The Government’s Plan for Growth, published in March 2011, announced the transformation of incentives at local level for efficiency in initiation and delivery of research. For clinical trials we have, since 2012, published outcomes against public benchmarks, including an initial benchmark of 70 days or less from the time a provider of NHS services receives a valid research application to the time when that provider recruits the first patient for that study. In future, Department of Health funding to providers of NHS services is becoming conditional on meeting benchmarks, including a 70-day benchmark to recruit first patients for trials. This was made a condition of new contracts from autumn 2011 and performance will affect funding from 2014. This information has been published on a quarterly basis since January 2015.  The criteria for submission is that the trial was approved within the last twelve months and fell into one of the following criteria

a) A clinical trial of an investigational medical product

b) Clinical investigation or other study of a medical device

c) Combined trial of an investigational medicinal product or an investigational medical device

d) Other clinical trial to study a novel intervention or RCT to compare interventions in clinical practice

In the last year LCHS has approved one trial which meet the criteria, known as ‘Performance in initiation’ details are given below

Research Ethics Committee Reference NumberName of TrialDate of Receipt of Valid Research ApplicationDate of NHS PermissionFirst Patient RecruitedDuration between VRA and First PatientBenchmark MetReasons for delay correspond to:
13/YH/0066PRESSURE 208/10/201514/10/2015Yes6YesBoth
15/EM/0538The Amulance Hypo Study28/03/201629/03/2016No1Within 70 daysSponsor
15/EM/0291Wren Study17/02/201618/02/2016Yes1YesPlease Select...