CP-105 Clinical trials in haematology

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Abstract

Background

UFA—‘Unità farmaci Antiblastici’ of our hospital is involved in the management of several profit and non-profit clinical trials, increasingly based on new molecules or therapeutic associations that are administered intravenously or subcutaneously.

Purpose

The aim of this study was to evaluate the trend in clinical trials and to emphasises the role of the hospital pharmacist.

Material and methods

For the two haematology departments in the hospital and the use of Log80 software, we collected qualitative and quantitative data from a dedicated database which contains the number of trials approved, type and phase of the trials, drugs used, number of patients enrolled and date of authorisation by the ethics committee.

Results

From 2011 to August 2016, 40 profit and 18 non-profit trials were authorised; 328 patients were enrolled, including 160 patients with multiple myeloma, 101 patients with non-Hodgkin’s lymphoma of various histology, and 23 patients with acute lymphoblastic leukaemia and chronic lymphocytic leukaemia. The largest number of trials were for multiple myeloma and non-Hodgkin lymphoma. Regarding the drugs used, 15.50% of patients were treated with carfilzomib and 12.16% with bortezomib. 25 of 58 were phase 2 studies.

Conclusion

The data show that clinical research is constantly evolving, allowing the study of new therapies in onco-haematology and subsequently the increase in the number of clinical trials conducted in highly specialised centres. In accordance with this scenario, the hospital pharmacist plays an important role in the management and monitoring of clinical trials. The development of new organisational procedures and cooperation among all professionals involved are required to ensure adherence to Italian Norme di Buona Preparazione

References and/or acknowledgements

Antonio D’Avino, et al. Il farmacista nella gestione delle sperimentazioni cliniche: analisi delle sperimentazioni farmacologiche condotte dal 2011 al2014 all’ INT. G. Pascale Bollettino SIFO 2-2016.

References and/or acknowledgements

No conflict of interest

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