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CPC-110 Pharmacy Involvement in the Management of Academic Clinical Trials
  1. C Breuker,
  2. F Bringer,
  3. N Gastaut,
  4. M Naud,
  5. A Castet-Nicolas,
  6. S Hansel-Esteller
  1. CHRU de Montpellier, Pharmacie Lapeyronie - Arnaud de Villeuneuve, Montpellier, France

Abstract

Background The sponsor is the person or entity that initiates a clinical trial, manages it and provides funding. We define two types of promoters, commercial sponsors and academic sponsors (mainly hospitals). In order to minimise the cost of academic studies without limiting the quality, some work done by the hospital is not included, for example pharmaceutical management by pharmacies.

Purpose To measure the size of pharmacy involvement in the management of clinical studies and academic costs not taken into account.

Materials and Methods We accounted for all pharmaceutical work done for academic studies (dispensing, preparation, reception of goods or materials, destruction of goods or materials, monitoring, labelling, ordering, randomization) managed by our pharmacy during the year 2011. We estimated the average time for each of these duties and the resulting financial cost (national grid, LEEM).

Results 35 institutional studies were in progress during this period and represented approximately 20% of all studies managed by our service: 8 studies were promoted by Montpellier hospitals, 7 by associations and 20 by other hospitals. We noted 501 prescriptions dispensed, 180 assignments to treatment or randomization, 52 preparations, 138 receptions, 13 destruction, 55 orders, 416 labels prepared and 52 monitoring visits. All this took 736.5 hours (or 210 half days) and additional costs estimated at 45,752 euros. Only 8,865 euros were allocated to the pharmacy (19% of the costs).

Conclusions Academic research is essential and necessary for the improvement of scientific knowledge. However, in most cases, no expenditure is planned for the pharmacy unit. Currently, these activities are made within the hospital pharmacist’s “free time”. A national reflection is currently under way to establish a grid indicating how much academic studies should pay for the recruitment of dedicated medical staff. This study demonstrates that academic research requires a considerable time from the pharmacies, to justify the allocation of human resources in order to support good management.

No conflict of interest.

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