By Julio G. Martinez-Clark, CEO, bioaccess
Clinical research is critical in advancing medical knowledge and improving patient care. It involves testing new drugs, devices, and procedures to determine their safety and effectiveness. Clinical trials are the cornerstone of clinical research and require careful planning, execution, and analysis. In recent years, El Salvador has emerged as a promising destination for medtech clinical research due to its favorable regulatory environment, skilled workforce, and diverse patient population.
Many Latin American countries are compelling destinations for conducting medtech early feasibility studies (EFS) and first-in-human (FIH) studies due to their faster and predictable regulatory approval timelines; ethnically diverse populations; high rates of urbanization; solid doctor-patient relationships; and their ethical, quality, and lower-cost clinical research as compared to the cost of research in the U.S.1
El Salvador is embarking on an ambitious economic reform agenda to overcome decades of low growth and stagnant productivity, combined with the devastating impact of the COVID-19 crisis.2 El Salvador’s economy has transformed radically over the last half century from a traditional exporter of agricultural products (coffee, cotton) and an incipient light industrial sector to a net exporter of population and offshore production goods and an extensive service sector. In 2001, the country implemented the U.S. dollar as a legal tender. In this article, we will explore the role of El Salvador in clinical research and the opportunities it presents for the medtech innovation industry in the U.S.
El Salvador's Role In Clinical Research
El Salvador is a small country in Central America with about 6.5 million people.3 With 65 percent of its population living in urban areas, El Salvador is the most densely populated country in the Americas.4 Despite its size, it has been actively involved in clinical research for many years. The country's well-established healthcare system provides quality care to its citizens. It also has a strong tradition of academic medicine, with several universities and research institutions conducting cutting-edge research. El Salvador has also established partnerships with international organizations such as WHO and the Pan-American Health Organization (PAHO) to support research activities.5,6
In recent years, El Salvador has emerged as a preferred destination for medtech clinical research. The country offers several advantages, such as a diverse patient population, a skilled workforce, and a favorable regulatory environment. El Salvador's healthcare system is well-equipped to handle clinical trials, with several public hospitals and private clinics providing state-of-the-art facilities and services. The country has a large pool of potential participants for clinical trials, including patients with rare and chronic diseases. Also, U.S. medtech sponsors can expect significant savings in hospital fees in El Salvador. The cost of living in El Salvador is about 60% less than in the U.S.7
Benefits Of Conducting Medtech Clinical Trials In El Salvador
El Salvador offers several benefits for medtech clinical trials. It is an attractive destination for U.S. startup companies seeking cost-effective and quality EFS and FIH clinical data. One of the main advantages is the country's diverse patient population. El Salvador has a mix of ethnicities and races, making it an ideal location for clinical trials that require a diverse patient pool. This diversity can help ensure that the results of clinical trials are more generalizable to different populations.
Another advantage of conducting medtech clinical trials in El Salvador is the country's favorable regulatory environment. The country has a well-established regulatory framework for clinical research aligned with international standards. The regulatory process is streamlined, and the approval process is relatively fast and predictable compared to other countries in Latin America. This means that researchers can start their clinical trials sooner, reducing the time and cost of the overall process.
El Salvador's skilled workforce is another advantage for clinical trials. The country has many healthcare professionals, including physicians, nurses, and clinical research coordinators. These professionals are trained to conduct clinical trials and are familiar with international guidelines and standards. This expertise and the regulatory oversight of research centers can help ensure clinical trials are conducted to the highest quality and safety standards.
El Salvador's Regulatory Framework For Clinical Research
El Salvador has a well-established regulatory framework for medtech clinical research. The National Drug Administration (Dirección nacional de medicamentos (DNM)) at the Ministry of Health (MOH) oversees clinical trials in the country. It has extensive experience evaluating medtech EFS and FIH studies. DNM has established guidelines and regulations for conducting clinical trials, which align with international standards. The regulatory process is divided into two sequential phases: the DNM regulatory approval of the clinical trial and the national ethics review board approval. El Salvador's regulatory framework for clinical research is designed to protect study participants' rights and welfare while ensuring the clinical trial's quality and safety.
The first step is the regulatory approval of the clinical trial involving DNM reviewing the study design, the safety and efficacy of the investigational device, and the inclusion and exclusion criteria for study participants. The DNM approval process is relatively fast, with most protocols being reviewed within 30 days.8 DNM is open to working with the medtech industry and quickly responds to sponsor requests for pre- and post-submission meetings.
The country has established a national ethical review board called Comité nacional de ética de investigación en salud (CNEIS) to review the ethical implications of clinical trials. CNEIS comprises ethics, law, and medical experts and ensures that the clinical trials are conducted ethically and responsibly.
The second step is the CNEIS bioethical approval of the clinical trial itself, which involves reviewing the informed consent form, recruiting study participants, and the monitoring plan of the study. The CNEIS approval process is relatively fast, with most protocols being reviewed within 30 days.9
The DNM has also established a rigorous process to authorize new research centers to conduct clinical research. This process ensures new research centers have standard operating agreements (SOPs), have qualified personnel, and comply with international Good Clinical Practices (GCP) guidelines.10
Overview Of Current Clinical Trials In El Salvador
ClinicalTrials.gov profiles 59 studies in El Salvador since 2005; four have been FIHs involving an investigational ophthalmology medical device.11 El Salvador engages in clinical trials across therapeutic areas. International sponsors are conducting these trials and cover a wide range of indications, including cancer, diabetes, cardiovascular diseases, and infectious diseases.
El Salvador has made significant advancements in clinical research in recent years. The country has partnered with international organizations, such as WHO and the PAHO, to support research activities. These partnerships have helped strengthen the country's research infrastructure and build capacity in clinical research.5,6
El Salvador has also established a national registry of clinical trials, which provides information on ongoing and completed clinical trials in the country. The registry is designed to improve transparency and accountability in clinical research and facilitate collaboration between researchers and sponsors.12
The country has also invested in research and development, with several universities and institutions conducting cutting-edge research. These institutions are focused on developing new treatments and therapies for some of the world's most pressing healthcare challenges, such as cancer, infectious diseases, and chronic conditions.
Challenges And Opportunities In Conducting Clinical Trials In El Salvador
While El Salvador offers several advantages for clinical trials, some challenges must be addressed. One of the main challenges is the need for more awareness among the general population about clinical trials. Many people need to become more familiar with clinical trials and may hesitate to participate. This lack of awareness can make recruiting participants for clinical trials challenging.
Another challenge is the need for more infrastructure in some areas of the country. While El Salvador has a well-established healthcare system, some areas may need more facilities and services to conduct clinical trials. This can make it challenging to conduct trials in specific therapeutic areas or recruit participants from certain regions.
However, these challenges also present opportunities for improvement. By increasing awareness about clinical trials and building capacity in underdeveloped areas, El Salvador can expand its clinical research capabilities and attract more sponsors and researchers to the country.
We must recognize El Salvador's contribution to the medtech innovation ecosystem, and the future looks promising. The country's participation in clinical trials has generated valuable data on the safety and efficacy of new treatments and therapies, which can help improve patient care and outcomes. El Salvador's diverse patient population and favorable regulatory environment make it an attractive destination for U.S. medtech startup sponsors.
The country is well-positioned to become a hub for EFS and FIH clinical research in the region, with its favorable regulatory environment, skilled workforce, and diverse patient population. El Salvador's government has recognized the importance of clinical research in advancing medical knowledge and improving patient care and has made significant investments in this area.
The country's research infrastructure is expected to grow, with more hospitals and clinics providing state-of-the-art facilities and services for clinical trials. El Salvador's partnerships with international organizations are also expected to continue, providing valuable support and resources for clinical research.
While there are challenges to conducting medtech clinical trials in El Salvador, these challenges also present opportunities for improvement. By increasing awareness about clinical trials and building capacity in underdeveloped areas, El Salvador can expand its clinical research capabilities and contribute to the medtech innovation ecosystem in the U.S.
- LATAM's Regulatory Framework For Medtech Early Feasibility Studies. Clinical Leader. [Online] November 11, 2022. [Cited: May 18, 2023.] https://www.clinicalleader.com/doc/latam-s-regulatory-framework-for-medtech-early-feasibility-studies-0001.
- El Salvador: Economic Recovery and Transformation. The World Bank. [Online] [Cited: May 9, 2023.] https://www.worldbank.org/en/programs/competitiveness-for-jobs-and-economic-transformation/brief/el-salvador-economic-recovery-transformation.
- El Salvador Population (LIVE). Worldometer. [Online] [Cited: May 9, 2023.]
- Wikipedia. Demografía de El Salvador. [Online] [Cited: May 9, 2023.] https://es.wikipedia.org/wiki/Demograf%C3%ADa_de_El_Salvador.
- Organización Panamericana de la Salud. Organización Panamericana de la Salud. [Online] [Cited: May 9, 2023.] https://www.paho.org/es/salvador.
- Acerca de OPS/OMS El Salvador. Organización Panamericana de la Salud. [Online] [Cited: May 9, 2023.] https://www.paho.org/es/salvador/acerca-opsoms-salvador.
- El Salvador vs United States - Cost of Living Comparison . LivingCost.org. [Online] [Cited: May 18, 2023.] https://livingcost.org/cost/el-salvador/united-states.
- Dirección Nacional de Medicamentos. [Online] [Cited: May 9, 2023.] https://www.medicamentos.gob.sv/.
- Comite Nacional de Etica de Investigación en Salud. Comite Nacional de Etica de Investigación en Salud. [Online] [Cited: May 9, 2023.] https://cssp.gob.sv/servicios/descarga-de-documentos/comite-nacional-de-etica-de-investigacion-en-salud/.
- Dirección Nacional de Medicamentos. Establecimientos. [Online] [Cited: May 24, 2023.] https://www.medicamentos.gob.sv/?p=2258.
- ClinicalTrials.gov. [Online] [Cited: May 9, 2023.] https://beta.clinicaltrials.gov/search?locStr=El%20Salvador&country=El%20Salvador.
- Dirección Nacional de Medicamentos. [Online] [Cited: May 9, 2023.] https://www.medicamentos.gob.sv/?wpdmcategory=ensayos-uic.
About The Author:
Julio G. Martinez-Clark is co-founder and CEO of bioaccess, a market access consultancy that works with medical device companies to help them do early-feasibility clinical trials and commercialize their innovations in Latin America. Julio is also the host of the LATAM Medtech Leaders podcast: A weekly conversation with Medtech leaders who have succeeded in Latin America. He serves as an advisory board member for Stetson University's Leading Disruptive Innovation program. He has a bachelor's degree in electronics engineering and a master's degree in business administration.