The Trust is committed to providing an open and transparent service for the population we serve. This coupled with the Governments Plan for Growth published in March 2011 we are required to publish data related to our research activity. WE will be reporting on our research activity every 3 months and this will be listed under 3 headings- 1. Performance in Initiating Research (i.e. the time it takes us to approve a trial and start recruiting our first patient), 2. Performance in Delivering Research (i.e. whether we meet our recruitment target in the set time). 3. Total number of patients recruited to research projects (this includes all patients participating in all types of research across the trust).
For the first two headings data is required for all clinical trials which have received NHS permission since 1st April 2014. A clinical Trial is defined using the categories of:
1) Clinical Trial of an investigational medicinal product
2) Clinical investigation or other study of a medical device
3) Combined trial of an investigational medicinal product and an investigational medical device
4) Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice.
Performance in Initiating Research
This table shows the clinical trials we have approved since 1st April 2014 and if we have entered the first patient into the trial within the 70 day target. This information is for any trial regardless of whether it is commercial or non-commercial or whether it is adopted on to the NIHR portfolio or not. There will be times when it is not possible to recruit a patient within 70days and we are required to give a reason for this. There are specific categories we can use for this:
1) Relevant permissions delay and not granted in time e.g. REC,MHRA, R&D
2) Study suspended by sponsor
3) Study closed by sponsor
4) Delays caused by sponsor e.g. delay in provision of pharmacy manual, delayed site initiation visit, protocol amendment
5) Staff availability issues at site
6) No eligible patients seen during this reported period
7) Eligible patients seen during the relevant period but not consented to participate
8) Contracting delays
9) Rare or very rare diseases (this is a disease affecting less than 1 in 100,000)
10) Other
Performance in Delivering Research
This table shows the trials that were open or have opened since 1st April 2014 and whether we meet our recruitment target in the agreed time. This information is limited to commercial trials only whether it is adopted onto the NIHR portfolio or not.
Performance in Initiating Research
This table shows the trials that were open or have opened since 1st April 2014 and whether we meet our target of opening the trial and achieving the first patient recruited within 70days of valid research application. This is for all clinical trials whether it is adopted onto the NIHR portfolio or not.
Total number of patients recruited into research
This shows the number of patients recruited to all studies whether defined as a clinical trial or not. The table shows number of patients recruited to all studies conducted across the trust whether adopted onto the NIHR portfolio or not regardless of whether it is a commercial or non-commercial study.
