Phase III randomized clinical trials global distribution and funding: Trends and disparities.

Abstract

e18563 Background: Phase III clinical trials (PIIICT) constitute the cornerstone of the progress and development of new therapeutic strategies. However, their complexity and costs in a scenario of limited funding sources impose important limitations in their scope and reach. Methods: We searched in clinicaltrials.gov to identify PIIICT evaluating pharmacological interventions in adjuvant, neoadjuvant and metastatic settings between 2010-2020 in breast, cervix, colorectal cancer (CRC), lung, melanoma, prostate and penile cancer. Trials identified were categorized according to disease site, funding source and world region/country (R/C). Case incidence in 2020 was collected from the IARC website. Results: Of 825 clinical trials, 72.7% were industry-sponsored (IS). Trials by R/C, not including multicentric studies (61.8%): (A) USA 76 trials, 53.9% non-industry sponsored (NIS); (B) Europe/UK 112, 59.8% NIS; (C) Asia (excluding China) 62, 27.4% NIS and (D) China 183, 43.7% NIS. There was a statistically significant association between location and funding source (p= 0.0003). NIS source was detected in higher proportion of trials ongoing in regions A and B (59%). IS was statistically less frequent in uterine cervix/penis (42.8%) and CRC (49.6%) IS was significantly higher in lung and prostate trials (both 81%) (p<0.0001). Table summarizes our results by tumor sites. We also found a statistically significant association between the incidence of malignancies in the selected primary sites and the amount of registered clinical trials, overall (p<0.0001) and IS as well (p<0.0001). The database is under expansion to include other disease sites as well as other geographic areas separately (Africa, Russia, South America, India, and Oceania). Cervix and penile results were combined given their biological and epidemiological similarities. Conclusions: There is a significant disparity between the number of clinical trials and tumor prevalences as well as among the distribution of IS trials funding.[Table: see text]