Why are we doing this?
- 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.
- Outcomes against contract NIHR benchmarks are required to be published.
- Improving clinical trial performance and reducing site set up and participant recruitment time, focus will be placed on transparency, accuracy, and meeting sponsor expectations. (Performance in Initiating of Clinical Research).
- It also includes the NHS providers performance in recruiting to time and target for commercial contract clinical trials (Performance in Delivery of Clinical Research).
What is a clinical trial?
A clinical trial is a set of medical research procedures conducted on human participants to allow safety and adverse effects of interventions, their efficacy, or their effectiveness to be established often by comparison with alternative or placebo/sham interventions. Interventions may be drugs, diagnostics, prophylactics, surgery, devices, non-invasive therapies, screening or other healthcare procedures or technologies.
What is a commercial contract clinical trial?
This is a clinical trial that is solely funded and sponsored by industry in which:
- the trial sponsor is the industrial company
- the trial is carried out with the aim of generating data for purposes such as Marketing Authorisations, safety monitoring and supportive evidence for claims
- the sponsor owns all the trial data and all Intellectual Property Rights and Know How arising directly from the trial.
Performance in Initiating and Performance in Delivery of Clinical Research
Click on the link below for the Trust’s information regarding the performance in initiating and performance in delivery of clinical research.
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