{
  "abstract": "Background and Importance The incidence of melanoma has increased markedly in recent years, prompting intensive research into new therapeutic options. Clinical trials (CTs) not only provide patients with access to innovative treatments but may also generate substantial economic benefits for healthcare systems, as investigational drugs are supplied by sponsors. Assessing these cost savings can help optimise healthcare resource allocation and reinforce the value of clinical research infrastructure within hospitals.Aim and Objectives To quantify the economic savings generated by the inclusion of melanoma patients in clinical trials during 2024 and to evaluate their impact on the costs associated with standard treatments.Material and Methods A retrospective observational study was conducted including all melanoma patients enrolled in CTs between January and December 2024 at a tertiary hospital. Economic savings were defined as the avoided cost of standard of care (SoC) drugs replaced by investigational products supplied by sponsors. For each patient, the estimated dose and number of cycles of SoC therapy were calculated based on the duration of participation in the trial. Standard therapies considered were: pembrolizumab (adjuvant, high risk stage II–IV melanoma); dabrafenib + trametinib (first-line (1L) metastatic BRAF-mutated melanoma); pembrolizumab (second-line (2L) metastatic BRAF-mutated melanoma); and pembrolizumab (1L metastatic BRAF wild-type melanoma). Data were obtained from Pk-ensayos and Farmis-Oncofarm software.Results Thirty-seven patients were included across eight active melanoma CTs: 11 in 1L metastatic BRAF wild-type trials, 3 in 1L metastatic BRAF-mutated trials, and 23 in adjuvant studies. The mean number of treatment cycles was seven (range 2–12). Based on 2024 average drug prices, total economic savings were estimated at €511,054.14, corresponding to a mean of €13,812.28 per patient.Conclusion and Relevance Participation in melanoma clinical trials generates substantial economic savings by reducing the use of costly standard therapies. These findings highlight the dual benefit of clinical research—improving patient access to innovative treatments and optimising healthcare resource utilisation. Strengthening hospital infrastructures dedicated to clinical research is essential to sustain these benefits and ensure the efficient and safe management of trialsConflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Hospital Regional Universitario De Malaga, Hospital Pharmacy, Malaga, Spain"
      ],
      "name": "B Lopez Bautis"
    },
    {
      "affiliations": [
        "Hospital Regional Universario De Málaga, Hospital Pharmacy, Malaga, Spain"
      ],
      "name": "E Alamino Arrebola"
    },
    {
      "affiliations": [
        "Hospital Regional Universitario De Malaga, Hospital Pharmacy, Malaga, Spain"
      ],
      "name": "C Garcia Fernandez"
    },
    {
      "affiliations": [
        "Hospital Regional Universitario De Malaga, Hospital Pharmacy, Malaga, Spain"
      ],
      "name": "B Tortajada Goitia"
    }
  ],
  "title": "1ISG-011 Economic savings derived from participation in melanoma clinical trials",
  "uid": "ff267d1d-0f4a-53b8-b470-adcd7b57ee97"
}