Background and Importance Previous 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 Objectives To describe and compare the characteristics of onco-haematological clinical trials opened in a tertiary hospital in 2016 and 2021.
Material and Methods All 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).
Results We 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 endpoint
Conclusion and Relevance Most 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 Acknowledgements 1. 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 Interest No conflict of interest.
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