Guest Column | September 11, 2023

The Landscape For Conducting Medtech Clinical Trials In The Dominican Republic

By Julio G. Martinez-Clark, CEO, bioaccess

Dominican republic-GettyImages-532049834

The Dominican Republic, a Caribbean nation with over 11 million people, has made strides in medtech clinical research and is experiencing an upward trend in attracting medical device clinical trials. This can be attributed to several factors, such as a growing economy, a favorable geographical location, a well-established healthcare system, and a large pool of potential trial participants. Clinical research not only proposes solutions to people's health problems but is also an opportunity for employment and development in the Dominican Republic.1 This article aims to provide a comprehensive overview of medical device clinical research in the Dominican Republic, focusing on new clinical trials' ethical and regulatory approval process, the challenges faced, and the potential for future growth.

The Healthcare System In The Dominican Republic

The population in the Dominican Republic is still relatively young (45% of the population was 24 years old or younger in 2020), even though demographic change has reached the Caribbean region (6.29% of the population was 65 years and older in 2020). Despite the challenges raised by the COVID-19 pandemic, the economy strongly recovered in 2021, and the country has experienced remarkable and continuous economic growth over the past 25 years. 2

Inequalities are still prominent in the country, and many people live in poverty and experience food insecurity. Income distribution remains unequal, the quality of health services is inadequate, and poverty still affects just over 40% of the population, with 10.4% living in extreme poverty. Most low-income families live in urban areas, and women head 63% of them.3 Most of the population must decide if they spend their money on food, medication, or housing.2

A large percentage of the population of the Dominican Republic suffers from food insecurity or obesity due to a lack of well-rounded nutrition. Both cardiovascular disease and diabetes are among the world’s leading causes of death and continue to rise. Reflective of international trends, rates of cardiovascular disease and diabetes are on the rise in the Dominican Republic. Hypertension is the second leading cause of death in the Dominican Republic, while diabetes is the sixth leading cause of death. Nearly 35% of Dominicans are hypertensive, and approximately 10% have diabetes.4,5

The Dominican Republic has a three-tier healthcare system. The first tier, which the government pays, guarantees free socialized healthcare for citizens. The second tier, the contributive tier, is paid for by employers and their employees. The third tier of healthcare, known as the contributive subsidized tier, is paid for by people whose income is higher than the national average and funded somewhat by the government.

Higher-income individuals will fall into this third category and must purchase private healthcare insurance for better access and quality. Although this is an additional expense, it costs less to see a doctor and receive treatment in a private hospital in the Dominican Republic than in the U.S. Private health insurance may cost up to $200 per month and covers most procedures, emergencies, and even some prescriptions. However, most people pay out-of-pocket for medical supplies and various services regardless of which tier they can access. Government-paid healthcare might be free, but it is below the standards of a first-world country.6

While the country's healthcare system is one of the more advanced among Caribbean nations, the disparity in access to quality healthcare in the Dominican Republic is enormous, especially in rural areas. The two large cities in the country, Santo Domingo and Santiago de los Caballeros, have many large, well-equipped hospitals. Still, most of the Dominican population does not live in the largest cities where healthcare is more easily accessible.5

Public hospitals need more staff, medical equipment, supplies, devices, and medications. Most patients must bring their supplies to the hospital. It is not uncommon for Dominicans to take care of their loved ones when they are in the hospital and bring food, medicine, supplies, etc. Santo Domino and Santiago de los Caballeros have first-class private, high-complexity hospitals offering the latest technology and methods and well-educated and experienced staff. Most of the personnel in these private hospitals will be able to communicate fluently in English, and many of them got educated abroad, probably in the U.S.7

Some top hospitals in Santo Domingo are United Hearts Clinic, Hospiten Santo Domingo, Hospital Padre Billini, Hospital Infantil Dr. Robert Reid Cabral, and others. The top hospitals in Santiago de los Caballeros are Clínica Unión Médica del Norte and Hospital Metropolitano de Santiago (HOMS). HOMS is regarded as the largest in the country and one of the most modern hospitals in Latin America and the Caribbean, with 300 doctors’ offices, 400 beds, 16 operating rooms, a hotel, and other specialized units.8

HOMS not only takes care of the Dominicans’ health but also allows foreigners to have the opportunity to receive high-quality healthcare at low prices in what is called "health tourism." HOMS has an investment of more than (U.S.) $80.0 million and will be looking to be accredited by the Joint Commission of International Hospital Accreditation.

The State Of Medtech Clinical Research In The Dominican Republic

In 2004, the Dominican Republic joined the Convention on Biological Diversity (CBD) as an Associate Member. The country signed the International Clinical Trial Registry (ICTR), the International Committee of Medical Journal Editors (CIMeJ), and other international clinical trial organizations. The country has had a national healthcare research policy since 2012, when it created Law 1-12, which formulated a 2030 vision for the country’s development called National Strategy for Development 2030. In 2022, the country announced its National Health Plan, PLANDES 2030, which formulates the long-term health vision and strategies to improve its healthcare system. The country also has a National Policy for Clinical Research. Fostering clinical research is an integral part of the country’s vision.9–12

According to ClinicalTrials.gov, since 2005, 223 medical device and drug clinical trials have been reported in the Dominican Republic, covering a wide range of topics. HIV/AIDS and lower respiratory infections were the two main areas of focus, followed by various other health conditions.13 Since 2005, there has been growth in the number of clinical trials conducted. In 2021, the national regulatory body received 57 protocols for review and approval; in 2022, it received 87 protocols, a 52% increase.14 It is crucial to note that the research addressing the health needs of Dominicans still needs to be expanded. As a result, there is a need to prioritize clinical research to better align with the burden of disease in the Dominican population. Last year, the Dominican Republic created a clinical research award to incentivize specialists to participate in clinical research projects.15

In recent years, the Dominican Republic has seen increased medical device clinical trials conducted within its borders. ClinicalTrails.gov shows 28 medical device studies since 2000. The country had one medical device study in 2020 and five in 2022, a 400% increase in studies. This growth can be attributed to several factors, including a growing interest in research in the country, improved infrastructure and training for researchers, and collaboration with international organizations. Hospital Regional José María Cabral y Báez and HOMS are examples of this progress. Their investigators are being trained in clinical research by the Harvard School of Public Health.16–18

The Dominican Republic has made progress in developing a regulatory framework for clinical research. The country has adopted legal instruments to govern research involving human participants, and in 2000, it implemented a national body tasked with approving new studies and overseeing research ethics committees (RECs). Despite these advancements, challenges still need to be addressed in terms of ethics training policies, clinical trial registration, and the adoption of guidelines on responsible conduct of research and accelerated ethics review for emergency research.

The general population in the Dominican Republic is open to participating in clinical trials. Clinical trials allow most Dominicans faster and easier access to the healthcare system, especially at private hospitals where most clinical trials happen. Also, physicians are revered as authoritative figures, and this collective sentiment nurtures a conducive environment for undertaking clinical trials, as the population deeply appreciates a physician's opinion and values clinical research's pivotal role in advancing healthcare and enhancing public health outcomes.

The Dominican Republic’s Advantages For Medtech Clinical Trials

The Dominican Republic is known for its robust healthcare infrastructure, experienced medical professionals, and diverse patient population. Here are some potential benefits of conducting clinical trials in the Dominican Republic:19,20

  1. Healthcare Infrastructure: The Dominican Republic has a well-developed healthcare system with modern facilities and advanced medical technology. This infrastructure provides a solid foundation for conducting clinical trials and ensures access to quality healthcare for participants.
  2. Experienced Medical Professionals: The country boasts a pool of highly skilled and experienced medical professionals, including physicians, nurses, and researchers. Their expertise and knowledge can contribute to the success of clinical trials and ensure the safety and well-being of participants.
  3. Diverse Patient Population: The Dominican Republic has a diverse population, which can be advantageous for clinical trials that require a varied patient pool. This diversity allows for a broader representation of different genetic backgrounds and can enhance the generalizability of study results.
  4. Streamlined Regulatory Processes: The Dominican Republic has implemented regulatory frameworks that simplify the approval process for clinical trials. This efficiency can expedite the start of trials and reduce bureaucratic hurdles, saving time and resources for researchers and sponsors.
  5. Cost-Effectiveness: Clinical trials in the Dominican Republic may be cost-effective compared to other countries. Factors such as lower labor costs and reduced administrative expenses can contribute to cost savings for sponsors.

Ethical And Regulatory Approval Process In The Dominican Republic

The ethical and regulatory approval process for clinical trials in the Dominican Republic is a critical aspect of ensuring that research conducted within the country adheres to international standards and safeguards the well-being of study participants.

Research Ethics Committees (RECs): Institutional RECs play a central role in the ethical oversight of clinical research. These committees review and approve research protocols, ensuring the study adheres to ethical principles and international guidelines, such as the Declaration of Helsinki and the Council for International Organizations of Medical Sciences (CIOMS) guidelines. The Consejo Nacional de Bioética en Salud in the Dominican Republic, CONABIOS (National Bioethics Council in Health) oversees RECs. This council is part of the Ministry of Health and establishes policies and procedures for the scientific, methodological, and bioethical review and approval of research involving human participants.21,22

Ethics Review Process: The ethics review process in the Dominican Republic begins with submitting the study documents to the institutional REC and then to CONABIOS.23 The protocol should include a detailed description of the study objectives, methodology, and potential risks and benefits to participants. The protocol should also outline measures to protect participant confidentiality and informed consent procedures.

The REC first reviews the protocol and may request revisions or additional information before approval and submitting the protocol to CONABIOS. Once the REC and CONABIOS grant approval, the study can commence. Researchers must provide regular updates to CONABIOS and the REC, and any changes to the protocol must be submitted for review and approval. The REC takes an average of 30 days to review and approve the study. CONABIOS takes an average of 45 days and up to 120 days.

Clinical Trial Registration: Besides obtaining ethical approval, researchers conducting clinical trials in the Dominican Republic must register their studies on clinical trial databases, such as clinicaltrials.gov. This registration process aims to promote transparency and accountability in clinical research, ensuring that the research community and the public have access to information about ongoing and completed clinical trials.

Medtech companies usually choose a destination country for their clinical trials based on three factors: Fast and predictable regulatory approval times (120 days or less), subject recruitment potential, and cost savings. The Dominican Republic checks positively on each of these factors. The Dominican Republic, Honduras, and El Salvador are now the top destinations in Latin America for medical device clinical trials. These three countries have predictable and fast regulatory approval processes to attract foreign investment in clinical research.

Addressing Challenges In Clinical Research In The Dominican Republic

Despite the progress made in recent years, several challenges still need to be addressed in the field of clinical research in the Dominican Republic. These challenges include:

  • Limited Resources and Infrastructure: As a developing country, the Dominican Republic's resource limitations impact clinical research. These limitations include a need for more local funding for research projects, limited access to specialized research training, and inadequate infrastructure for conducting clinical trials in public hospitals. Addressing resource limitations is critical to promote the growth of clinical research in the Dominican Republic. This could include funding research projects, investing in research infrastructure, and improving access to specialized training.
  • Regulatory and Ethical Challenges: While the Dominican Republic has made progress in developing regulatory frameworks for clinical research, there is still room for improvement. Researchers need help navigating the ethical approval process, which can be time-consuming and complex. Additionally, there is a need for more significant investment in the training and support of RECs, ensuring they have the necessary resources and expertise to oversee clinical research effectively. Improving the ethical and regulatory frameworks for clinical research ensures that studies conducted in the Dominican Republic adhere to international standards and safeguard participant well-being. This effort could involve providing additional resources and training for RECs, streamlining the ethical approval process, and promoting the adoption of policies on responsible conduct of research.
  • International Collaboration and Cooperation: International collaboration is essential for advancing clinical research in the Dominican Republic. However, challenges exist in fostering effective partnerships with international organizations and researchers. These challenges include differences in regulatory requirements, ethical standards, and research priorities. Enhancing international collaboration and cooperation can help overcome barriers in clinical research and promote sharing resources, expertise, and best practices. This could involve establishing partnerships with international organizations, participating in multicenter clinical trials, and promoting the exchange of researchers and trainees between countries.
  • Aligning Research Priorities with the Burden of Disease: As noted earlier, the current focus of clinical research in the Dominican Republic only sometimes aligns with the population's disease burden. There is a need to prioritize clinical research that addresses Dominicans' most pressing health needs, ensuring that resources are directed toward studies with the most significant potential to improve health outcomes.

Conclusion

The Dominican Republic has emerged as a promising destination for medical device clinical trials, offering a favorable regulatory framework, robust infrastructure, and a diverse patient population. The country's growing economy and well-established healthcare system contribute to its attractiveness as a location for clinical research. However, challenges such as limited awareness of clinical trials and infrastructure gaps in rural areas must be addressed. By leveraging opportunities and addressing challenges, the Dominican Republic can further enhance its position as a leading destination for medical device clinical trials in the region.

References

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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 has a bachelor's degree in electronics engineering (BSEE) and a master's degree in business administration (MBA).