A comprehensive mapping of cancer clinical trials in Brazil

Laura Mendonça Diefenthaeler^1,2,3, Julia Kasali Lima^1,2, Maria Carolina Buj¹, Giovani Gadonski^1,4,5, Matheus Gadonski Stortti Rosa¹, Alexandre Vieira¹, Gustavo Werutsky³, Roberta Pozza^1,6 and Juliana Giacomazzi^1,5,7

¹Let Me Trial, Porto Alegre, RS 90619-000, Brazil

²Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS 90050-170, Brazil

³Latin American Cooperative Oncology Group (LACOG), Porto Alegre, RS 90619-900, Brazil

⁴Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, RS 90610-000, Brazil

⁵Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, RS 90619-900, Brazil

⁶Universidade do Vale do Taquari (UNIVATES), Lajeado, RS 95914-014, Brazil

⁷Programa de Pós-Graduação em Epidemiologia, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS 90035-003, Brazil

Abstract

Purpose: To overview interventional cancer clinical trials in Brazil, assessing distribution, phase, sponsorship and alignment with national cancer epidemiology and disparities.

Methods: Data on ongoing cancer trials in Brazil were extracted from ClinicalTrials.gov (9 October 2024) using filters for interventional, recruiting or not-yet-recruiting studies. Information from the Brazilian Registry of Clinical Trials and Plataforma Brasil was reviewed for contextual comparison. Descriptive and geospatial analyses used Looker Studio and Tableau. Epidemiological data from the Instituto Nacional do Câncer, Instituto Brasileiro de Geografia e Estatística and Global Cancer Observatory were correlated with trial distribution and compared with selected high-income countries.

Results: A total of 272 ongoing cancer clinical trials were identified, representing 2.55% of global cancer studies. Late-phase trials predominated (54.8% Phase III; 77.6% Phases II–IV), and industry sponsorship accounted for 78.7%. Trials were heavily concentrated in the Southeast (48.3%) and South (26.4%) regions, with site densities of 1.46 and 1.98 per million people, respectively; in contrast, the North had only 0.37. Lung (18.8%) and breast (16.9%) cancers were the most frequent focus, while paediatric trials comprised only 1.1%. Underrepresentation of cervical, gastric and penile cancers – tumour types linked to socioeconomic vulnerability – was notable.

Conclusion: Brazil’s oncology research ecosystem shows strong industry engagement but remains regionally imbalanced and heavily focused on late-phase studies. Addressing these disparities requires strategic expansion of research capacity and equitable access initiatives. Democratizing access to clinical trials – through interoperable national registries, public policies and digital platforms that connect patients, physicians and research centres – is essential to ensure that innovation reaches all populations across Brazil. Strengthening academic leadership, fostering early-phase research and integrating digital and governmental efforts can bridge structural gaps and align national oncology research with global standards of equity and inclusion.

Keywords: clinical trials as topic, cancer care facilities, health policy

Correspondence to: Juliana Giacomazzi
Email: juliana.giacomazzi@letmetrial.com

Published: 10/08/2026
Received: 28/01/2026

Publication costs for this article were supported by ecancer (UK Charity number 1176307).

Copyright: © the authors; licensee ecancermedicalscience. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Introduction

Brazil, the largest country in Latin America, spans approximately 8.51 million km² and is home to a culturally and ethnically diverse population exceeding 210 million people [1], representing nearly 2.6% of the global population. Approximately 75% of the Brazilian population is covered by the Sistema Único de Saúde (Unified Health System) (SUS) [2], a public health system that faces significant challenges in ensuring equitable access to healthcare, particularly in oncology [3]. Stark disparities between the public and private healthcare systems contribute to inequality, directly impacting cancer care and patient outcomes [4].

The projected 68.8% increase in cancer incidence – from 627,183 cases in 2022 to an estimated 1,058,865 by 2045 – alongside a 79.7% rise in cancer-related mortality underscores the urgent need for comprehensive strategies to improve access to cancer screening, diagnosis and treatment [5].

The Brazilian Ministry of Health (MoH) has implemented several oncology-related policies with demonstrated effectiveness. These include national programs for cancer prevention and control, particularly for breast and cervical cancers. The National Policy for Cancer Prevention and Control mandates comprehensive cancer care through over 315 specialised facilities [6], such as UNACON (High Complexity Oncology Care Unit) and CACON (High Complexity Oncology Care Center), which provide diagnosis, staging and treatment [7]. Additionally, initiatives like the radiotherapy expansion plan (SUS) aim to enhance radiotherapy services across SUS-qualified hospitals, reducing technological dependence and addressing regional disparities in oncology care. The ministry has also launched initiatives to train healthcare professionals and maintain both hospital- and population-based cancer registries. However, persistent challenges – including limited funding and Brazil’s vast territorial dimensions – contribute to fragmented cancer care, ultimately leading to poorer outcomes [5].

Participation in cancer clinical trials offers a crucial opportunity to expand access to innovative treatments for both public and private healthcare patients. Clinical trial engagement not only provides patients with novel therapeutic options when standard treatments are insufficient or unavailable but also fosters the continuous training of healthcare professionals and the development of specialised facilities. This, in turn, strengthens Brazil’s clinical research infrastructure, enabling earlier access to cutting-edge medical technologies [8]. Furthermore, a robust clinical research ecosystem supports economic growth and reinforces the sustainability of SUS, equipping the healthcare system to address future challenges more effectively [9].

Against this backdrop, this study aims to assess the landscape of cancer clinical research in Brazil. It will examine the national research infrastructure, the distribution of trials by cancer type and region, trial phases, sponsorship sources and their alignment with Brazil’s cancer epidemiology and healthcare disparities.

Methodology

Data extraction and sources

To explore the landscape of cancer clinical trials in Brazil, we collected data from ClinicalTrials.gov, supplemented by a review of the available information from the Brazilian Registry of Clinical Trials (ReBEC) and Plataforma Brasil. ClinicalTrials.gov is a global database of privately and publicly funded clinical studies, managed by the U.S. National Library of Medicine at the National Institutes of Health (NIH). REBEC is overseen by the Oswaldo Cruz Foundation in collaboration with the Brazilian MoH, the National Health Surveillance Agency and the National Commission for Ethics in Research (CONEP). Plataforma Brasil is managed by CONEP, which operates under the Conselho Nacional de Saúde (National Health Council) within the Brazilian MoH.

Data collection process

A custom Python script within Google Colab Notebooks was used to extract clinical trial data via the ClinicalTrials.gov API. The search was conducted on 9 October 2024, using the following filters: search term ‘cancer’, location ‘Brazil’, recruitment status set to ‘RECRUITING’ and ‘NOT_YET_RECRUITING’, and study type defined as ‘INTERVENTIONAL’. This extraction identified active and early-stage cancer clinical trials in Brazil. Data on Brazilian cancer research sites and ongoing trials were sourced directly from ClinicalTrials.gov.

Data cleaning and standardisation

Following data extraction, a comprehensive analysis was performed to identify patterns and research gaps, offering insights into Brazil’s cancer clinical trial landscape. To enhance accuracy, ZIP codes were standardised and corrected using Excel spreadsheets, ensuring precise association between clinical trial sites and their respective locations.

Data analysis and visualisation

Looker Studio and Tableau were used for data processing, geospatial mapping and quantitative visualisation. These tools enabled a detailed representation of ongoing trials, focusing on geographical distribution and quantitative aspects of cancer research sites in Brazil.

Epidemiological data integration

Population and cancer epidemiological data were obtained from the 2025 Instituto Brasileiro de Geografia e Estatística (IBGE) Censos, Instituto Nacional do Câncer (INCA) estimates and Global Cancer Observatory.

International comparative analysis

A simplified search on ClinicalTrials.gov was conducted to extract cancer trial data from developed countries, including the United States, Japan, Canada and the United Kingdom. This comparison provided a broader perspective on the global cancer clinical trial landscape in relation to Brazil.

Results

Overview of ongoing cancer clinical trials in Brazil

A total of 272 ongoing cancer clinical trials were identified, representing 2.55% of all global cancer trials registered on ClinicalTrials.gov. Most studies were conducted in advanced phases, with Phase III trials accounting for 54.8% and later-phase trials (Phases II/III, Phase III and Phase IV) comprising 77.6% of the total. The vast majority (88.2%) included both adult (18–64 years) and older adult (65+) participants, whereas only 1.1% focused exclusively on paediatric populations. These findings highlight Brazil’s strong participation in late-stage and industry-led cancer research while underscoring limited inclusion of paediatric and early-phase studies. An overwhelming 78.7% of trials are industry-sponsored, highlighting the dominant role of pharmaceutical companies in driving oncology research in Brazil. Academic or investigator-initiated trials represent a small minority, emphasizing the need for greater support of public and academic clinical research initiatives to ensure broader representation and diversity in study populations (Figure 1).

Therapeutic areas and drug classes under investigation

Cancer trials in Brazil focus predominantly on lung (18.8%), breast (16.9%), gastrointestinal (13.2%), urogenital (11.8%) and head and neck cancers (8.8%) (Figure 1). The most frequently studied therapeutic agents include antineoplastic drugs (205 trials), immunological antineoplastic agents (109), enzyme inhibitors (89) and immune checkpoint inhibitors (67). These categories reflect the global trend toward targeted and immunotherapy-based treatments.

Geographic distribution and research density

The distribution of cancer research sites is highly concentrated in the Southeast and South regions, which together host 74.7% of all cancer research sites in Brazil (Figures 1 and 2). The South shows the highest trial-site density (1.98 sites per million people), followed by the Central-West (1.16), Southeast (1.46), Northeast (0.66) and North (0.37). Despite their large populations, the North and Northeast regions remain underrepresented, with Acre, Amapá, Amazonas and Sergipe lacking active research centres. Moreover, 66.9% of all sites are located in capital cities, which poses potential barriers for patients in remote or underserved areas (Table 1).

Figure 1. Overview of cancer clinical trials conducted in Brazil (a–e). (a): Trial phases. (b): Ages. (c): Location. (d): Trials per cancer type. (e): Lead sponsor. Source: Authors’ elaboration based on data from ClinicalTrials.gov.

Figure 2. Geospatial mapping of cancer research sites in Brazil and density. Source: Authors’ elaboration based on data from ClinicalTrials.gov, ReBEC, Plataforma Brasil and IBGE (2025).

Table 1. Distribution of Brazilian cancer research sites by state and population.

Regional correlation between cancer incidence and research activity

The South and Southeast regions not only have the highest cancer incidence rates but also the most extensive research networks, with numerous sites located beyond capital cities – particularly in São Paulo, Rio Grande do Sul, Santa Catarina and Minas Gerais. In contrast, Rio de Janeiro exhibits high cancer incidence yet a centralised concentration of research in the capital, while Espírito Santo displays fewer sites and lower incidence overall.

In the Central-West, particularly in the Distrito Federal and Goiás, research activity is relatively strong despite moderate incidence rates. Within the Northeast, states such as Bahia, Ceará and Pernambuco demonstrate higher research output compared to neighbouring states, although overall incidence is lower than in southern regions. Notably, Rio Grande do Norte presents few sites but considerable trial volume, suggesting concentration of multicentre activity. In the North, which has the lowest national incidence, most states lack active centres, with Pará, Rondônia and Amazonas being rare exceptions – though their participation remains limited. Among them, Pará stands out with one highly active cancer clinical trial site involved in 15 trials (Table 2).

Table 2. Clinical trials by cancer type, regional availability and estimated cancer incidence (2023).

Distribution of clinical trials

Please refer to Tables 1 and 2 at the end of the document.

Discussion

This study provides a comprehensive overview of interventional cancer clinical trials in Brazil, revealing pronounced disparities in trial distribution, site density and cancer types under investigation. To our knowledge, this is the first nationwide analysis aligning cancer trial data with demographic and epidemiological indicators, offering an updated picture of Brazil’s clinical research ecosystem. The data were obtained exclusively from ClinicalTrials.gov, which captures most ongoing cancer clinical trials in Brazil; however, data from ReBEC and Plataforma Brasil were unavailable for extraction and therefore excluded.

Brazil – ranking sixth globally in cancer incidence, with approximately 627,000 new cases in 2022 [10] – exhibits marked inequalities in clinical research distribution both within the country and compared with global patterns. The Southeast and South regions dominate the national landscape, accounting for 74.7% of all trial sites, with site densities of 1.46 and 1.98 per million people, respectively. In contrast, the North has only 0.37 sites per million, reflecting a structural imbalance in research infrastructure, consistent with previous reports [11, 12]. Globally, similar inequities persist: trial-site densities reach 540 in the United States, 202 among other high-income Organisation for Economic Co-operation and Development countries, and fall sharply to 41 in upper-middle income, five in low-middle income and two in low-income countries [13]. These findings reinforce the need for more equitable research distribution across Brazil’s vast territory.

The predominance of trials in the Southeast and South reflects the concentration of advanced infrastructure, academic centres and experienced research teams [11]. Expanding trial capacity to underserved regions is crucial to addressing geographic inequities in access to innovation. The absence of a centralised, user-friendly national registry compounds this challenge. While ClinicalTrials.gov remains the primary source of information on ongoing trials, it is available only in English and omits certain locally registered studies [14]. National platforms such as ReBEC and Plataforma Brasil, although valuable, lack real-time interoperability. Moreover, Plataforma Brasil was not designed to function as a public search interface for ongoing studies, serving primarily as an ethics submission and approval management system [15]. These structural limitations restrict accessibility, public awareness and patient engagement – key pillars of equitable research and broader participation in clinical trials.

Brazilian trials are predominantly late-phase: 54.8% are Phase III and 19.5% are Phase II. Early-phase studies (Phase I or I/II) are underrepresented, constraining opportunities for novel drug development and investigator-led innovation. Comparatively, countries such as the United States and Canada exhibit more balanced distributions across phases [13]. Greater public and academic investment could strengthen early-phase capacity and enhance Brazil’s global contribution to oncology research.

Paediatric oncology research remains extremely limited, with only 9.9% of trials including children and just three trials exclusively focused on paediatric patients. This proportion is notably lower than in the United Kingdom (17.4%), Japan or Canada, where dedicated frameworks encourage paediatric inclusion [16]. Strengthening regulatory incentives and international collaborations could foster paediatric trial development and ensure access to innovation for younger patients.

Industry sponsorship accounts for 78.7% of Brazilian cancer trials – well above the proportions observed in the United States (35.4%) and Canada (55.3%) [12]. Although private-sector investment is vital, this dependency narrows the research agenda toward commercially driven priorities. Strengthening public and academic networks – such as INCA, Latin American Cooperative Oncology Group and major universities – could enable more diverse, population-relevant studies addressing public health priorities and rare or neglected cancers.

In line with global patterns, Brazilian trials focus primarily on lung (18.8%) and breast cancers (16.9%) [10]. However, cancers with high incidence and mortality in Brazil – such as cervical, gastric and penile cancers – remain underrepresented in research. Given their strong association with social vulnerability, increasing support for trials targeting these tumour types would align national research priorities with the Sustainable Development Goals on health equity [14, 17].

Brazil currently hosts Latin America’s largest research portfolio of the U.S. NIH [17], reflecting its large population, linguistic homogeneity and urban patient concentration (61%), all of which facilitate recruitment and follow-up. Moreover, as nearly 75% of the population depends on the public healthcare system (SUS), clinical trials frequently represent the only pathway to innovative treatments. Expanding patient and physician engagement in trials can therefore play a pivotal role in advancing both research and care. Although official data on patient participation rates are lacking, enrolment appears substantially lower than in high-income countries – such as the 7.1% participation rate observed in the U.S. – suggesting untapped potential [16]. Extending trial access beyond metropolitan areas could improve both scientific representation and treatment equity.

Study limitations

This study is limited by its reliance on ClinicalTrials.gov, which does not include all cancer trials conducted in Brazil. Local registries such as REBEC and Plataforma Brasil contain additional data, but their lack of full integration with international databases may result in missing trials. Additionally, some trials may not be registered at all or may appear in alternative global registries, influencing the completeness of our analysis.

Conclusion

Addressing the geographic, financial and research-phase disparities in Brazil’s clinical trial landscape is critical to enhancing national and global contributions to cancer research. By expanding trial access, diversifying funding sources and leveraging technology, Brazil can strengthen its role in oncology innovation, ensuring that patients across the country receive equitable opportunities to participate in cutting-edge treatments.

Conflicts of interests

• Laura Mendonça Diefenthaeler

  • Employment: Latin American Cooperative Oncology Group (LACOG)

• Julia Kasali Lima

  • Employment: Let Me Trial

• Roberta Pozza

  • Employment: Instituto Tacchini de Pesquisa em Saúde/Hospital Tacchini, Tacchini Sistema de Saúde, Bento Gonçalves, Brazil

  • Employment: Let Me Trial and UNIVATES

• Juliana Giacomazzi

  • Research Funding: Roche/Genentech (Inst), FAPERGS

  • Employment: Let Me Trial and Pitt-Giacomazzi Consulting

• Gustavo Werutsky

  • Honoraria: AstraZeneca, MSD Oncology, Novartis, Roche, Pfizer, Daiichi Sankyo/AstraZeneca

  • Consulting or Advisory Role: AstraZeneca, MSD, Novartis, Daiichi Sankyo/AstraZeneca, Roche

  • Research Funding: AstraZeneca/MedImmune (Inst), Roche/Genentech (Inst), GlaxoSmithKline (Inst), Novartis (Inst), Pfizer (Inst), Roche (Inst), MSD (Inst), Merck (Inst), Bayer (Inst), Janssen (Inst), Astellas Pharma (Inst), Libbs (Inst), Takeda (Inst)

  • Employment: Latin American Cooperative Oncology Group (LACOG)

• Maria Carolina Buj

  • Employment: Let Me Trial

• Giovani Gadonski

  • Employment: Let Me Trial and PUCRS

• Matheus Gadonski Stortti Rosa

  • Employment: Let Me Trial and Souto Correa

This work has been presented at the Sociedade Brasileira de Oncologia Clínica (SBOC) 2025 Congress.

Funding

This study was developed by the Let Me Trial team and sponsored by Let Me Trial. Let Me Trial is a science-based digital health platform developed by an academic spin-off healthtech incubated at Tecnopuc/Biohub–PUCRS (Brazil), operating under a hybrid academic–commercial model with governance mechanisms to preserve public-interest objectives. The platform has free access and no costs and functions as a system-level intervention by systematically identifying, mapping and curating all active oncology and onco-haematology clinical trials conducted nationwide. Publicly available trial registries (ClinicalTrials.gov and WHO ICTRP) are integrated with an API and manual academic curation. The platform supports clinicians in identifying appropriate trials, assessing eligibility criteria and referring patients following informed consent, while the Let Me Trial team provides patients with guided navigation through research pathways. All processes comply with Brazilian data protection legislation (LGPD) and international ethical research standards. Implementation outcomes were assessed descriptively since April 2025, using reach, referral and enrolment indicators, as well as exploratory estimates of health system cost avoidance associated with sponsor-funded investigational treatments.

Author contributions

All authors meet the four criteria (substantial contributions, drafting or revising, final approval and accountability) for authorship as defined by the International Committee of Medical Journal Editors (ICMJE).

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