Experimental Medicine (EM) Research
Experimental Medicine (EM) spans the transition between the pre-clinical/clinical boundary, from ‘first-in-human’ studies through to the equivalent of Phase II clinical trials. This would include studies that are undertaken in human participants, or using human tissues that aim to identify mechanisms of pathophysiology or disease, demonstrate proof-of-concept, or the validity of new experimental designs and approaches. If proved successful at this stage, these trials can inform the development of later phase clinical trials.
To prioritise patient safety at NIHR Sheffield CRF, we have formed the Experimental Medicine Study Review Group (EMSRG). This group is responsible for the review of early phase EM studies and comprises of experienced research nurses with input from other clinical trial staff, including physicians, pharmacists, and research coordinators. The group focuses on risk assessments and provides recommendations for safe trial delivery, including staffing levels (medical and nursing), emergency scenario planning, staff training and environmental considerations such as waste disposal for genetically modified organism (GMO) waste.
The NIHR Sheffield CRF offers dedicated research facilities in a specialist environment for the conduct of high quality clinical research including EM studies, and intensive later phase studies.