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Birmingham and Solihull Mental health NHS Foundation Trust
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Clinical trials in the Trust: our performance in setting up and recruiting to studies

The Department of Health requires all Trusts to report on its performance in setting up and recruiting to high quality clinical trials.

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.

Clinical trials are not limited to drug studies. They can be one of the following:

  • Clinical trial of an investigational medicinal product (the traditional drug study)
  • Clinical investigation or other study of a medical device
  • Combined trial of an investigational medicinal product and an investigational medical device
  • Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice


Updates on our performance are provided to the Department of Health on a quarterly basis.

If you have any queries or require further information please contact us on:

bsmhft.researchinnovation@nhs.net

Initiating

This measures our performance against a 70 day benchmark. The Trust must recruit the first participant to a clinical trial within 70 days of receiving the nationally defined ‘local document set’ from the study team.

Embedded within this, the Trust must aim to review and provide permission for a clinical trial to take place within 40 days of receiving the application.

This is for all clinical trials which have been granted permission by the Trust within the last year. From the table below, you will see how we are performing in terms of getting these.

Delivering

This measures whether the Trust achieved the target number of recruits for a study, within the time frame mutually agreed between the Trust and the study team.

This is for clinical trials which are funded and sponsored by a commercial company only and that have closed to recruitment within the last year. The information in the table below shows how we are performing in terms of this.