Details

Autor(en) / Beteiligte

• Martinez Barros, H
• Díaz Gago, Á
• Rodriguez Marin, M
• Gemeno Lopez, E
• Pueyo López, C
• Lavandeira Perez, M
• Poveda Escolar, A
• Alvarez Dian, AM

Titel

6ER-010 Evolution of onco-haematological clinical trials from 2016 to 2021: experience from a tertiary hospital

Ist Teil von

• European journal of hospital pharmacy. Science and practice, 2023-03, Vol.30 (Suppl 1), p.A163-A163

Ort / Verlag

London: British Medical Journal Publishing Group

Erscheinungsjahr

2023

Link zum Volltext

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• Background and ImportancePrevious work has described changes in the trends in onco-haematological clinical trials in recent years, describing an increase in the use of surrogate endpoints, changes in their funding or a greater number of non-randomised trials (1, 2).Aim and ObjectivesTo describe and compare the characteristics of onco-haematological clinical trials opened in a tertiary hospital in 2016 and 2021.Material and MethodsAll interventional clinical trials initiated in our hospital in 2016 and 2021 were included. The following variables were collected: title, funding, tumour site, blinding, control, randomisation and primary endpoint. Data were compared using the Pearson χ2. Results were deemed statistically significant at p<0.05. Statistical analysis was performed using STATA (StataCorp, Texas, USA).ResultsWe found 89 interventional clinical trials started in 2016 and 71 studies in 2021. The majority were in the Medical Oncology service (93.6% and 83.1%). Breast cancer accounted for the largest number of trials initiated (22.5% and 19.7%). In both study periods, most clinical trials were industry-sponsored, with an increase over time (82.0% vs 94.4%; p=0.019). More than half of the studies initiated were controlled (58.4% vs 54.9%; p>0.05), randomised (59.6% vs 66.2%; p>0.05) and open-label (78.7% vs 67.6%; p>0.05), with no statistically significant differences between 2016 and 2021. An increase in the number of phase 3 clinical trials was observed (37.0 vs 54.9%; p = 0.017), with a predominance of open-label design (54.6% vs 51.3%; p>0.05) and the use of surrogate endpoints as primary outcomes (54.5 vs 69.2%; p>0.05). No trial had quality of life as a primary endpointConclusion and RelevanceMost phase 3 clinical trials used an open-label design and surrogate endpoints as primary outcomes.Although this is a single-centre analysis, some trends observed by other authors, such as a higher number of industry-sponsored studies, were observed.None of the 160 clinical trials initiated had quality of life as a primary endpoint.References and/or Acknowledgements1. Del Paggio JC et al. Evolution of the Randomized Clinical Trial in the Era of Precision Oncology. JAMA Oncol. 2021 May 1;7(5):728-734.2. Wesson W et al. Characteristics of clinical trials for haematological malignancies from 2015 to 2020: A systematic review. Eur J Cancer. 2022 May;167:152-160.Conflict of InterestNo conflict of interest.