Pharmaceutical circuit of clinical trials including an pharmaceutical preparation : standardization for optimisation

Objectives

Clinical trials which include a pharmaceutical preparation (of investigational medicinal product –IMP), under industrial or institutional promotion, are more and more frequent, and can present preparation, control lab and clinical trial pharmacy staffs to a work overload that can disorganise routine activity. An anticipated assessment of this activity ensures the successful conduct of these trials. Thus, implementing an internal and structured organization is necessary to ensure coordination and standardization of the process and good communication between each partner: investigators, clinical research associates (CRA), the Clinical research and Innovation Office, pharmacies of associated centres, etc…

Methods

A multidisciplinary work group consisting of the pharmacists from the 3 sectors of our hospital pharmacy worked on a methodological and standardized process to define:

• the feasability of a new clinical trial with a pharmaceutical preparation
• the programmation of the preparation campaigns of IMP batches
• the programmation of extemporaneous IMP preparations

Results

The process standardization consisted of

• the development of a feasability grid, allowing the scoring by the three sectors of : technical and financial feasability, ethical feasability, organisational feasability and human feasability. The grid has been approved by the hospital direction. It justifies the acceptance or the rejection of the conduct of a new clinical trial with a parmaceutical preparation, or its conduct according to negotiated financial/human conditions.
• The setting up of a shared calendar that lists the scheduled daily preparations of IMP for each patient in the coming months
• The planning of regular meetings between pharmacists, with investigators and/or CRA as one-time guests, to draw up a statement of patient’s inclusions and IMP used in each associated center and thus those to be prepared, taking are into account the preparation stability

Discussion-Conclusion

This internal reorganization ensures the securisation of the IMP circuit and has promoted links and communication with investigational care units. It also opened the way to scientific collaborations with medical staffs such as patent applications related to IMP preparations from internal promotion clinical trials.