4CPS-012 Classification and assessment of the complexity of onco-haematology clinical trials from a pharmacy service perspective

<h3>Background and Importance</h3> Clinical trials in onco-haematology are a breakthrough in cancer treatment, but require meticulous management by the pharmacy service (PS) due to their complexity. <h3>Aim and Objectives</h3> To classify onco-haematology clinical trials (CTs) and to assess their complexity from the point of view of the PS. <h3>Material and Methods</h3> Retrospective observational descriptive study of onco-haematological CTs initiated in 2023 in a tertiary hospital. Following characteristics were analysed/collected for each CT: research phase and pathology treated. Complexity was assessed using the Calvin et al. complexity scale, considering aspects like blinding, number of drugs, PS professionals involved, dispensing method, IT system usage, dosing, storage conditions, and need for special packaging. CT complexity was categorised as low (6–10 points), moderate (11–19 points), and high (20–33 points). Overall complexity was calculated by pathology and phase. Fundanet was used for data extraction and Excel for data analysis. <h3>Results</h3> In 2023, 84 CTs were initiated, 58 (69%) in oncology and 26 (31%) in haematology. Of the total CTs, 25 (30%) were in phase I, 30 (36%) in phase II, 27 (32%) in phase III, and 2 (2%) in phase IV. In oncology, lung and breast cancer were the pathologies with the most CTs (16 CTs, 28% and 12 CTs, 22% respectively), while in haematology, lymphomas had 7 CTs (28%) followed by leukaemia with 6 CTs (23%). Of the evaluated CTs, 62 (74%) had moderate complexity (mean score 16; SD: 4), 15 (18%) low (10; SD: 1), and 7 (8%) high (21; SD: 4). The aspects that most increased complexity were: number of drugs involved, dispensing method, and storage conditions. Of the 7 highly complex CTs, acute myeloid leukaemia (AML) and lung cancer were the most frequent pathologies, 29% in both cases. Most highly complex trials were phase I (57%). <h3>Conclusion and Relevance</h3> 36% of analysed CTs included phase II drugs. The most studied pathologies were lung cancer, breast cancer, lymphomas, and leukaemias. 74% of CTs had a moderate overall complexity. AML and lung cancer were the most complex pathologies, and phase I trials scored the highest on the Calvin et al. Scale. Performing such evaluations allows to understand the complexity of CTs and allocate resources more efficiently. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest