Background Clinical research and participation in clinical trials are still relatively new areas for many hospices and end of life care organisations, particularly if they are non-NHS organisations. One of the more challenging areas of research is that of participation in Clinical Trials of Investigational Medicinal Products (CTIMPS).
Aim The aim of this piece of work is to develop a tool that can be shared with other organisations, both regionally and nationally, to assist them in their preparation for participation in clinical trials.
Methods There are many potential challenges for non-NHS organisations to consider before deciding whether they wish, and are able to, participate safely and effectively in CTIMPS. Although none of these are insurmountable it is important that each aspect is addressed individually to provide the organisation with assurance that the research can be undertaken and delivered safely and to best practice in accordance with regulatory frameworks and guidelines.
The starting point has been to identify the potential challenges. These include but are not limited to:
Risk and Indemnity
Medicines and Healthcare Regulatory Agency (MHRA)
Drug storage and processes
Tissue samples/storage (HTA)
Results The result of the work thus far is a paper identifying the potential challenges in more detail and the specific issues that require attention.
Conclusions As this is an ongoing project there are no conclusions as yet. The next phase is completion of a RAG rated GAP analysis to identify gaps in current processes, provisions and risks. Once identified, all areas will require careful consideration, associated risks will need to be identified and considered and measures put in place to mitigate these are far as possible.