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Research and Clinical Trials

The Pharmacy Clinical Trials team provide specialist services ensuring the safe, appropriate and effective implementation and management of clinical trials involving investigational medicinal products (CTIMP’s) in the Trust.

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The team consists of experienced pharmacists and technicians who have undergone specific trials training (ICH/GCP) to ensure their knowledge is up-to-date in this specialist field. This ensures that CTIMP’s are conducted in accordance with regulatory requirements relating to the handling and dispensing of medicinal products in clinical trials.

The Trust is a research active teaching hospital. The pharmacy clinical trials team currently manage approximately 70 clinical trials. In addition there are many clinical trials in the ‘set up’ phase, which will be ready to recruit patients in the future.  Research active studies involving medicines are carried out in many specialities in the Trust, including rheumatology, gastroenterology, diabetes, ante-natal, stroke, renal, paediatrics, ophthalmology, oncology and haematology.

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The majority of trials are carried out on an out-patient basis but some patients are enrolled into studies as inpatients (e.g. specialities including stroke, haematology & oncology). All trials are different. Some trials are simple in design, whereas others are complex and the duration for patient participation can vary from a few days to many years.

The pharmacy clinical trials team collaborate with many professionals throughout the Trust, including medical & nursing staff, pharmacists & pharmacy technicians, clinical trials nurses, research & development staff and local researchers, as well as drug companies, clinical trials units & sponsors.

A study cannot commence until all regulatory approvals have been received. The regulatory bodies consist of the MHRA (Medicines & Healthcare Regulatory Agency), R&D (Research & Development) and Ethics Committee. Audits or MHRA inspections can be carried out at any time for any study in order to ensure the trials are being conducted correctly.

In addition to implementation and management of studies, assistance in design of locally sponsored studies, sourcing of materials and assistance in obtaining the necessary regulatory approval for local studies can be given.