Abstract P4-15-05: Participation of emerging regions in practice-changing breast cancer trials over the last three decades
Authors: Machado Andres , Rodriguez Clara , Migliaro Andrea , Fresco Rodrigo 
Published: March 2020

Abstract
Introduction: Conduction of clinical trials (CT) became increasingly globalized and has expanded beyond the established regions of North America and Western Europe. Although emerging regions are attractive due to easier access to a treatment-naïve population, faster recruitment and lower costs, some challenges are involved. Knowledge about the conduction of CT in emerging regions is relevant to better understand the implications of CT globalization.
Objective: Assess the contribution of selected emerging regions to practice-changing breast cancer (BC) trials, contrasted to an established one.
Methodology: We conducted a descriptive analysis of the contribution of 3 emerging regions to practice-changing BC trials: Latin America and the Caribbean (LATAM); East Asia (E. Asia) and Eastern Europe, Northern/Central Asia (Non-Western Europe); and an established one: US-Canada (US-Can). Practice-changing CT were defined as those that supported FDA approval of a new drug or indication. We identified all FDA-approved drugs for BC treatment from Jan-1992 to Dec-2018. For each drug we identified the applicable practice-changing CT through the latest package insert and analyzed the corresponding publications. The main variables evaluated were: participating countries, sites/country and authors/country. Participating sites data was obtained from ClinicalTrials.gov if it was not available in the publication. To better correlate each region´s contribution, we adjusted the number of CT to the average number of medical doctors (MD) and the average BC incidence in each region (obtained from the World Health Organization and GLOBOCAN, respectively).
Results: 34 CT that led to the approval of 17 drugs were included. LATAM participated in 24 (70%), E. Asia and Non-Western Europe in 19 (54%), and US-Can in 32 (94%). 42% of LATAM countries participated in at least one trial, 63% in E. Asia and 30% in Non-Western Europe. Additional data is shown in Table 1. The number of CT in emerging regions was negligible until ~2001, when a progressive increase is observed (Table 2). In the last 2 years (2016-18) the number of CT in these regions more than doubled the one in the 2011-15 quinquennium. Number of practice-changing CT conducted in US-Can over the last decade is similar to the one in each of the emerging regions. Despite, contribution in terms of authorship is much lower in these regions (LATAM: 0.7 authors/CT, E. Asia: 2 authors/CT, Non-Western Europe: 0.6 authors/CT, US-Can 6.6 authors/CT). E. Asia has shown a steady increase in authorship contribution since 2011 (Table 2).
Conclusion: Although the majority of CT are still being run in established regions, we showed that the number of practice-changing BC CT in emerging ones is currently equivalent to US-Can, what also led to more authorship opportunities. Number of sites per trial is higher in US-Can, what may reflect sponsor´s higher interest in this region and poorer enrollment rates compared to emerging ones. The ongoing globalization of clinical research is an opportunity for all stakeholders and efforts should be made to enhance it.
Table 1 - Region´s data of interestTrialsLATAME. AsiaNon-Western EuropeUSA- CanNumber of CT (Total = 34)24191932Number of CT per 100.000 MD1.70.632.026.6Number of CT per 10.000 new BC cases/year1.20.41.71.2Percentage of region’s countries participating in at least one CT426330100Mean number of countries per CT3.22.91.51.7Mean number of sites per CT13.521.18.057.6
Table 2 - Number of practice-changing CT and authors per-5 year period1992-19951996-20002001-20052006-20102011-20152016-2018Total number of CT185749LATAM024747E. Asia001549Non-Western Europe002539US-Can165749Total number of authors239395342101LATAM022633E. Asia00051023Non-Western Europe000433US-Can23737382672
Citation Format: Andres Machado, Clara Rodriguez, Andrea Migliaro, Rodrigo Fresco. Participation of emerging regions in practice-changing breast cancer trials over the last three decades [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-15-05.