The University Hospitals Birmingham Pharmacy Clinical Trials Service plays a key part in assisting the delivery of interventional trials involving medicines within the trust.
Whilst some trials involve the use of existing marketed products, others use new investigational medicinal products (IMPs), formulations or methods of administration. The Pharmacy Clinical Trials Service has experience in the delivery of a range of clinical trials from Phase I healthy-volunteer studies to Phase IV post-marketing studies, UHB-sponsored studies, other non-commercial/academically-sponsored studies and commercially-sponsored studies including some using novel and advanced therapies, such as novel chemotherapeutic drugs, monoclonal antibodies and gene therapy, all in a variety of therapeutic settings.
Working closely with the R&D governance and operations teams, the primary role of the Pharmacy Clinical Trials Service in relation to clinical trials is to safeguard the patient, the prescriber and the Trust by ensuring that medicines used in clinical trials are appropriate for use and are procured, handled, stored, used correctly and safely and disposed of appropriately, in accordance with the trial protocol and relevant legislation. For this reason clinical trial investigators will delegate the responsibilities relating to IMP management to the Pharmacy Clinical Trials Service which include:
- The safe handling, storage and dispensing of IMPs
- The correct receipt and recording of deliveries of IMPs
- The maintenance of accurate accountability records to allow full reconciliation and audit trail of IMPs
- The return of unused IMP to the trial sponsor or its adequate disposal
- The safe keeping of randomisation/blinding information
- The provision of information to trial subjects/research teams on how to administer IMPs
- The aseptic manipulation of IMPs where necessary
In addition to the key roles above, the Pharmacy Clinical Trials Service will advise investigators on all aspects of IMP management during protocol development for studies where UHB will be acting as sponsor, including the procurement and labeling of IMPs to ensure they meet the legislative requirements. They will also assist the Protocol Development Service by helping to prepare research bids for UHB and the University of Birmingham for studies involving IMPs to ensure the IMP costs and the IMP management is adequately resourced.
Following an 18 month project, the new Radiopharmacy opened at QEHB in April 2014. This unit replaced an aging 28 year unit that had served the Trust admirably over the years and is a major development for the Queen Elizabeth Hospital Birmingham.
The Radiopharmacy provides clean room environments for the production and dispensing of a wide range of 99m-Technetium based and other radiopharmaceuticals used for diagnosis and the production and dispensing of a range of therapeutic radiopharmaceuticals. A dedicated blood labeling suite forms part of the new facility; here it will be possible to radiolabel erythrocytes, leucocytes, platelets and other blood products, both for diagnosis and research.
The new Radiopharmacy is located on the old hospital site and is in close proximity to the Welcome Trust research facility, the Cancer Centre and the planned Institute of Translational Medicine.
In due course an application will be made to the MHRA for a Manufacturing Specials licence, and an Investigational Medicinal Products Licence. Once these licences are in place it will be possible to offer a comprehensive clinical trials service including the radiolabelling of blood products such as Dendritic cells in conjunction with Birmingham University, and the radiolabelling of antibodies and peptides.
Other likely new developments will include the production of PET isotopes such as 68Gallium Dotatate; this will compliment and support the Trust’s newly awarded centre of excellence status for its neuroendocrine tumour service.
As nuclear medicine, molecular imaging and research continues to expand, the new radiopharmacy facility will ensure the capacity to meet the future demands of diagnosis, treatment and research for many years to come.
Gene Therapy Facility
A new gene therapy facility is being commissioned and will be available to support gene therapy trials in the very near future.
Contact Research Pharmacy
For further information on the Pharmacy Clinical Trials Service please contact:
Mrs Amisha Desai, Lead Pharmacist – Clinical Trials
Tel: 0121 627 8249