4CPS-150 Global evolution of clinical trials and pharmacy activities developed in a central Portuguese hospital from 2016 to 2023

<h3>Background and Importance</h3> Without effective treatment, an ageing population, new diseases, and rising antimicrobial resistance pose challenges. Clinical trials (CTs) are essential for proving drug efficacy and safety, facilitating access to innovative therapies, and advancing clinical research in Portugal. Legislation mandates Pharmaceutical Services’ participation in CTs, ensuring safety, responsibility, transparency, and traceability. <h3>Aim and Objectives</h3> To analyse the evolution of clinical trials and ULSLO’s Pharmaceutical Services over the past 8 years. <h3>Material and Methods</h3> Data were obtained from an Excel database and the CPC Glintt software. <h3>Results</h3> From 2016 to 2023, an average of 19 new CTs were approved annually, peaking at 37 in 2023. From 2016 to 2023, an average of 19 new CTs were approved annually, peaking at 37 in 2023. The average number of monitored CTs per year was 64, with 2023 having 92 ongoing trials across 26 departments. The top departments in 2023 were: Oncology 21% (n = 20), Neurology 19% (n = 18), Rheumatology 12% (n = 11) and Nephrology 11% (n = 10). Antineoplastics and immunomodulators led the ATC classification, followed by the central nervous system and cardiovascular system groups The Oncology and Haemato-oncology Unit saw the greatest increase in CTs. Between 2016–2023, around 60% of CTs were stage III (n = 171), 14% (n = 39) stage II, 9% (n = 26) stage IV and 16% (n = 38) other stages. A total of 90% (n = 85) of the TCs were promoted by the pharmaceutical industry and 10% (n = 9) by researcher initiatives. Regarding ED, pharmacists received (n = 13119), dispensed (n = 7339), prepared (n = 801) and returned to the supplier for destruction 3562 kits. <h3>Conclusion and Relevance</h3> Clinical studies are a key strategic area for health development in Portugal. The Clinical Innovation and Research Service promotes good clinical practice and supports study implementation, with oncology and neurology as areas of excellence. Highly qualified clinical research teams, including hospital pharmacists, ensure an efficient experimental drug circuit in compliance with legislation. The data aligns with indicators in the annual report from official regulatory entities in Portugal. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest

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Published
2025-03-01
DOI
https://doi.org/10.1136/ejhpharm-2025-eahp.216
Primary Topic
Health Systems, Economic Evaluations, Quality of Life
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article
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article

4CPS-150 Global evolution of clinical trials and pharmacy activities developed in a central Portuguese hospital from 2016 to 2023

Mónica Baptista, Fátima Falcão, Ana Mirco, Lesly Calixto-Aguilar et al.
Health Systems, Economic Evaluations, Quality of Life
article

4CPS-150 Global evolution of clinical trials and pharmacy activities developed in a central Portuguese hospital from 2016 to 2023

Mónica Baptista, Fátima Falcão, Ana Mirco, Lesly Calixto-Aguilar, Manuela Falcão, M Lobo Alves, T Laranjeira, Sofia Maia
article en

Abstract

<h3>Background and Importance</h3> Without effective treatment, an ageing population, new diseases, and rising antimicrobial resistance pose challenges. Clinical trials (CTs) are essential for proving drug efficacy and safety, facilitating access to innovative therapies, and advancing clinical research in Portugal. Legislation mandates Pharmaceutical Services’ participation in CTs, ensuring safety, responsibility, transparency, and traceability. <h3>Aim and Objectives</h3> To analyse the evolution of clinical trials and ULSLO’s Pharmaceutical Services over the past 8 years. <h3>Material and Methods</h3> Data were obtained from an Excel database and the CPC Glintt software. <h3>Results</h3> From 2016 to 2023, an average of 19 new CTs were approved annually, peaking at 37 in 2023. From 2016 to 2023, an average of 19 new CTs were approved annually, peaking at 37 in 2023. The average number of monitored CTs per year was 64, with 2023 having 92 ongoing trials across 26 departments. The top departments in 2023 were: Oncology 21% (n = 20), Neurology 19% (n = 18), Rheumatology 12% (n = 11) and Nephrology 11% (n = 10). Antineoplastics and immunomodulators led the ATC classification, followed by the central nervous system and cardiovascular system groups The Oncology and Haemato-oncology Unit saw the greatest increase in CTs. Between 2016–2023, around 60% of CTs were stage III (n = 171), 14% (n = 39) stage II, 9% (n = 26) stage IV and 16% (n = 38) other stages. A total of 90% (n = 85) of the TCs were promoted by the pharmaceutical industry and 10% (n = 9) by researcher initiatives. Regarding ED, pharmacists received (n = 13119), dispensed (n = 7339), prepared (n = 801) and returned to the supplier for destruction 3562 kits. <h3>Conclusion and Relevance</h3> Clinical studies are a key strategic area for health development in Portugal. The Clinical Innovation and Research Service promotes good clinical practice and supports study implementation, with oncology and neurology as areas of excellence. Highly qualified clinical research teams, including hospital pharmacists, ensure an efficient experimental drug circuit in compliance with legislation. The data aligns with indicators in the annual report from official regulatory entities in Portugal. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest

University of Lisbon (PT), Hospital de Egas Moniz (PT), Nova Medical (United States) (US), Centro Hospitalar Lisboa Norte (PT), Hospital de Santa Cruz (PT), Centro Hospitalar de Lisboa Ocidental (PT), Hospital of St. Francis Xavier (PT), Universidade Nova de Lisboa (PT)
Openalex Percentile: Top 93%
Health Systems, Economic Evaluations, Quality of Life
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