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OHP-011 Evolution of the pharmacist’s job in the area of clinical trials
  1. MA Arias Moya,
  2. M Bonilla Porras,
  3. EM Martín Gozalo,
  4. M Forte Pérez-Minayo,
  5. P Pelegrin Torres,
  6. FJ Bécares Martínez,
  7. E Castillo Bazán,
  8. M Hernández Segurado,
  9. MI Panadero Esteban,
  10. G Toledano Mayoral
  1. Hospital Universitario Fundación Jiménez Díaz, Pharmacy, Madrid, Spain

Abstract

Background Over the last few years we have seen an increase in the area of clinical trial activity. Specialist pharmacists have evolved in the clinical trials area and their role is already not limited solely to receiving, storing and dispensing the investigational product (IP).

Purpose To evaluate the evolution of the pharmacist’s job in the area of clinical trials and related areas.

Material and methods A retrospective observational study over six years. We collected the study variables: the number of meetings of the ethics committee, the number of clinical trials protocols evaluated, the number of clinical trials managed, the number of drugs received for clinical trials, the number of drugs dispensed in clinical trials, and the number of monitoring activities. The annual percentage increase of each of the variables was calculated.

Results The annual percentage increase between the years 2008–2009, 2009–2010, 2010–2011, 2011–2012, 2012–2013 for the variables studied were respectively 48%, 7%, 36%, 13% and 12% in the number of clinical trials protocols evaluated, -5%, 7%, 11%, 13% and 5% in the number of clinical trials managed, 26%, 16%, 56%, 18% and 4% in the number of drugs received for clinical trials, 79%, 36%, 69%, -69% and 32% in the number of clinical trials drugs dispensed and 16%, 29%, 42%, 3% and -3% in the number of monitoring activities.

Conclusion More and more clinical trials require a specialist pharmacist for specific jobs such as the randomization of subjects, IP masking, remote monitoring, sending information to monitors and intravenous cytostatic preparations made by the Pharmacy Service. Although monitoring activities were maintained in the years 2012 and 2013, it was difficult to measure the time spent on each; however the demand is perceived by the pharmacist as increasing over time.

References and/or acknowledgements No conflict of interest.

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