Challenges and Opportunities for Oncology Clinical Trials in Latin America

Challenges and Opportunities for Oncology Clinical Trials in Latin America

International Perspectives

Apr 07, 2021

By Matías Chacón, MD, Diego Enrico, MD, and Federico Waisberg, MD

Over the past 20 years, we have witnessed great advances in oncology. These outstanding improvements in cancer care have only been possible given the exponential growth of cancer research worldwide: the number of oncology clinical trials opened per year has increased 5-fold since 2000.1

Although the U.S. and Europe have historically been the leaders in conducting trials, recently, other regions have shown an increased development in clinical cancer research, such as Asia, followed by Africa, and Latin America and the Caribbean (LATAM). However, the gap between the regions is still substantial. Filtering the data on ClinicalTrials.gov indicates that while the U.S. and Europe take part in 81% of the total ongoing cancer clinical trials, LATAM is only participating in 5%.2 Furthermore, among the 20 countries of LATAM, the distribution of clinical cancer research participation is heterogeneously centralized in only six: Mexico, Brazil, Argentina, Chile, Colombia, and Peru.

Multifactorial reasons explain the substantial difference in clinical trial participation between high-income countries (HICs) and LATAM.

This vast region comprises 600 million people living in different socioeconomic, geographic, and environmental realities. Importantly, the proportion of gross domestic product (GDP) designated for research and development in LATAM was on average 0.75 in 2017, compared to 2.82 in the U.S. and 2.17 in Europe.3 As a consequence, almost the entire cancer clinical research environment in LATAM is sponsored by pharmaceutical companies.

Furthermore, there are substantial disparities in access to high-technology facilities in the field of surgery, radiotherapy, and diagnosis. Daily access to personalized cancer care in LATAM, such as molecular tests, targeted therapy, and immunotherapy, is also extremely inequitable. Other difficulties that are traditionally associated with low participation in clinical trials in our region include regulatory constraints, limited experience of health care facilities in clinical research in some countries of our region, and deficient cancer registries, which hamper doctors, researchers, funders, and patient participation.

Moreover, it should be highlighted that a high proportion of the population, including some government authorities, have fostered a negative opinion about industry-sponsored trials.  This mistrust may be influenced by the investigation of misconducts that gained media attention in the past.4,5 A renowned case in Argentina occurred in 2007, in a pneumococcal vaccine clinical trial which led to financial penalties charged to the sponsor and the involved investigators.6 A new regulatory framework was developed by the Argentinean Administration of Drugs, Foods and Medical Devices (ANMAT) in 2010 to promote quality and safety standards in clinical research.

Despite all these limitations, some winds of change are noticeable regarding clinical research in LATAM. This is a fundamental issue when we consider that by 2030, of the 20 million new cancer diagnoses estimated per year, the majority will occur in low- and middle-income countries.7

We have observed a confident environment regarding participation in clinical trials during the COVID-19 vaccine protocols.8 Even more, it is one of the first times that clinical research has gained favorable media attention in the LATAM region. This has helped to encourage a better and wider understanding of the importance of clinical trials in the expansion of medical knowledge and new treatments.

It should be highlighted that LATAM participated in 79 observational studies and 206 interventional trials from March to August 2020, according to the International Clinical Trial Registry Platform of the World Health Organization.8 Ultimately, many LATAM research groups, including basic, translational, and clinical investigators, have developed and executed timely research projects and were acknowledged as main authors in impactful publications.9-11

Other strengths should also be acknowledged. The ethnic diversity needed in cancer clinical trials is achievable in LATAM since our region comprises inhabitants with different ethnicities and ancestries, with the majority of the population fluid in only two languages, Spanish and Portuguese.

The economic impact is also noteworthy. The lower absolute costs of health care and clinical research in LATAM position our region as a great opportunity for investment in cancer research. In our view, structural changes, such as continuous training and the development of dedicated facilities, are needed to promote “a clinical research culture” in our region.

There is no doubt that working closely with collaborative cancer groups and international cancer societies is necessary. Illustrative examples have been developed by a number of partner-led networks, such as LACOG, SLAGO, and CLICaP.12 These constructive initiatives, which have enhanced the design and participation of clinical trials, should be expanded across more LATAM cancer centers. In this context, ASCO’s strong participation and support will be crucial for providing and promoting clinical research capacities and opportunities, as well as medical training.

It is imperative that government authorities work to develop and homogenize policies to improve investment and promote access to clinical trials. This partnership should strategically include regulatory authorities, health care providers, the pharmaceutical industry, and civil society.

It is a major challenge to LATAM not only to participate as a patient recruiter for trials designed and conducted in HICs, but also to build the basis for the creation of local innovative projects and co-develop trials with HICs.

In this time of change in LATAM, a “res, non verba” (“actions, not words”) approach should be the motto of the regional conception of cancer clinical trials.

Dr. Chacón is the head of the Medical Oncology Department at the Alexander Fleming Cancer Institute in Buenos Aires, Argentina. He is a past president of the Argentine Association of Clinical Oncology (AAOC). Disclosure.

Dr. Enrico is a medical oncologist at the Alexander Fleming Cancer Institute in Buenos Aires, Argentina. He is a member of the Research Committee of the Argentine Association of Clinical Oncology (AAOC). Disclosure.

Dr. Waisberg is a medical oncologist at the Alexander Fleming Cancer Institute in Buenos Aires, Argentina. He is also a member of the Research Committee of the Argentine Association of Clinical Oncology (AAOC). Disclosure.

References

  1. Annual number of oncology clinical trial starts worldwide from 2000 to 2018. Statista. Available at: https://www.statista.com/statistics/1092600/oncology-clinical-trial-starts-worldwide. Accessed Mar 10 2021.
  2. US. National Institutes of Health. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/. Accessed Mar 10 2021.
  3. World Bank. Available at: https://www.worldbank.org/en/home. Accessed Mar 10 2021.
  4. Novoa A. Ensayos clínicos con los pobres de Latinoamérica. Diagonal. Nov 4 2016. Available at: https://www.diagonalperiodico.net/cuerpo/29841-ciencia-deslocalizada-maquiladoras-ensayos-clinicos-con-pobres-latinoamerica.html.
  5. Ugalde A, Homedes N. The impact of researchers loyal to Big Pharma on the ethics and quality of clinical trials in Latin America. Salud Colect. 2015;11:67-86.
  6. Multan a laboratorio en Argentina por irregularidades en ensayo clínico. Ambito. Jan 3 2012. Available at: https://www.ambito.com/informacion-general/multan-laboratorio-argentina-irregularidades-ensayo-clinico-n3718567.
  7. Bray F, Jemal A, Grey N, et al. Global cancer transitions according to the Human Development Index (2008-2030): a population-based study. Lancet Oncol. 2012;13:790-801.
  8. Carracedo S, Palmero A, Neil M, et al. The landscape of COVID-19 clinical trials in Latin America and the Caribbean: assessment and challenges. Rev Panam Salud Publica Pan Am J Public Health. 2020;44:e177.
  9. Libster R, Pérez Marc G, Wappner D, et al. Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults. N Engl J Med. 2021;384:610-8.
  10. Simonovich VA, Burgos Pratx LD, Scibona P, et al. A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia. N Engl J Med. 2021;384:619-29.
  11. Rabinovich GA, Geffner J. Facing up to the COVID-19 pandemic in Argentina. Nat Immunol. 2021;22:264-5.
  12. Rolfo C, Caglevic C, Bretel D, et al. Cancer clinical research in Latin America: current situation and opportunities. Expert opinion from the first ESMO workshop on clinical trials, Lima, 2015. ESMO Open. 2016;1:e000055.

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