Evaluating Global Disparities in the Availability of Prostate Cancer Clinical Trials.

PURPOSE: Clinical trial availability often varies between countries, independent of the local burden of disease. We aimed to evaluate the current global availability of prostate cancer clinical trials and the factors affecting it.

METHODS

We searched for clinical trials involving prostate cancer between June 2019 and June 2024 through Clinicaltrials.gov. Noninterventional trials were excluded. Countries were classified according to the World Bank Ranking (WBR) as high-, upper-middle-, lower-middle-, and low-income countries (HICs, UMICs, LMICs, and LICs). Multivariable negative binomial regression was used to evaluate the association between the number of trials and country's characteristics. Multivariable logistic regression was used to evaluate the association between trial availability and country's characteristics. In addition, we collected data on sponsorship, funding, intervention, intervention intent, end point selection, trial phase, and cancer stage.

RESULTS

Of the 1,531 trials identified, 1,413 met the eligibility criteria. Most trials were conducted exclusively in HICs (80.4%), included patients with metastatic disease (55.4%), and were sponsored by academia (68.8%). Pharma-funded trials had a higher number of participating countries (mean 2.7 v 1.0, P < .001) and were more likely to include metastatic disease (72.0% v 32.3%, P < .001) and to investigate systemic therapy (76.3% v 29.4%, P < .001). In the multivariable analysis, WBR, gross national income (GNI), and annual health expenditure were all associated with the presence of at least one trial (P < .001). Only GNI was independently associated with the number of trials within a country (P < .001).

CONCLUSION

Prostate cancer trials are disproportionately concentrated in HICs despite a lower burden of disease. Intentional efforts are needed to ensure global representation and long-term benefits for populations historically excluded from research.