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4CPS-146 Economic impact on multiple myeloma clinical trials in the pharmacy service
  1. A Martinez Orea,
  2. P Torrano-Belmonte,
  3. MD Nájera Pérez,
  4. L Fructuoso Gonzalez,
  5. JA Gutierrez Sánchez,
  6. M Hernández Sánchez,
  7. M Guillén Díaz
  1. Hospital Morales Meseguer, Pharmacy, Murcia, Spain


Background and Importance Clinical trials (CTs) offer a chance to use innovative therapies, discover new treatments, and expand options for specific diseases. According to current legislation (RD1090/2015), sponsors are required to provide all investigational medication, except for certain exceptions.

Aim and Objectives Given the increase in clinical trials of multiple myeloma (MM) in our centre, we focused on determining the economic savings this entailed. This is because the medication for patients included in the trial was provided by the sponsor, resulting in zero cost for the centre.

Material and Methods Retrospective, single-centre observational study encompassed all MM CTs conducted at the hospital from 2018 to 2022. Exclusion criteria: CTs that did not enrol patients during the study period or did not dispense medication.

The calculation of medication cost savings took into account medications provided by CT sponsors, leading to reduced treatment expenses for patients since the hospital would have covered these costs if patients had not participated in the clinical trial. Medications not available on the market during the study period were not considered in the analysis. Cost calculations were based on PVL-DISCOUNT (discount agreed with the laboratories) +VAT at the time of the trial.

The main study variable was the avoided medication cost over 5 years, while secondary variables included the average cost saved per CT and the average cost saved per patient. The analysis did not take into account the cost of materials used in CT development, personnel, other medications, day hospital costs, etc.

Results Currently, there are 298 active CTs related to MM in Europe, of which 123 are in Spain, and 19 are in our region. Out of these 19 active CTs, 14 are active in our Health Area. However, one was excluded because no dispensations were made within the analysis period, resulting in a total of 13 included CTs (Phase I:0%; Phase II:33.3%; Phase III:66.6%), which recruited only 67 patients during the study period, due to the pandemic (average 5.15 patients/CT; range 1–22).

The direct cost saved over 5 years amounted to €2,920,608.28, average savings per CT €224,662.17.

Conclusion and Relevance In conclusion, the development of CTs in the study centre generated significant economic savings in MM treatment.This cost provided by sponsors should be reinvested in the creation of well-equipped clinical trial units.

Conflict of Interest No conflict of interest.

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