Exploring Panama's Landscape for First-in-Human and Early Feasibility Medical Device Clinical Trials

As you explore the world of medical device innovation, Panama emerges as a promising destination for first-in-human and early feasibility studies. This Central American nation, between Colombia and Costa Rica, offers unique advantages for conducting cutting-edge medical device clinical trials. With its strategic location, robust healthcare infrastructure, and favorable regulatory environment, Panama attracts worldwide attention from medtech companies and researchers.

You'll discover how Panama's landscape for first-in-human and early feasibility medical device clinical trials sets it apart from neighboring countries like Paraguay and Colombia. This article delves into Panama's rich history in medical research, examines the current scene for medical device trials, and highlights the benefits of carrying out these critical studies in Panama. By the end, you'll gain valuable insights into why Panama is becoming a go-to destination for groundbreaking medical device research and development.

Panama's Rich History in Medical Research

The Gorgas Memorial Laboratory

Panama has a rich history in medical research, particularly in tropical medicine. This legacy can be traced back to the early 20th century, when yellow fever posed a severe threat to U.S. troops during the Spanish-American War of 1898. In response, the U.S. Army established a Yellow Fever Commission, with American physician Dr. William Crawford Gorgas leading the charge in Cuba and the Panama Canal region. Gorgas' extensive research and control efforts were instrumental in allowing the Americans to complete the Panama Canal after the French had abandoned their construction due to the challenges caused by yellow fever and malaria.

In 1921, as a tribute to Dr. Gorgas' legacy, the government of Panama established a research laboratory called the Gorgas Memorial Laboratory (GML), which has since been renamed the Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES). The creation of the GML was further solidified in 1928 when U.S. Congressman Maurice Thatcher introduced the Gorgas Institute bill in the U.S. Congress. The bill was approved on December 20 of the same year, and the U.S. government allocated funds to operate the new research laboratory.

Contributions to Tropical Disease Research

The work conducted at ICGES has positioned Panama at the forefront of several experiments related to malaria and yellow fever research. ICGES has carried out control and prevention research on various parasitic diseases, including malaria, toxoplasmosis, leishmaniasis, Chagas disease, and diseases caused by arboviruses, retroviruses, arboviruses, papillomaviruses, respiratory viruses, and other. This research has had a significant impact on the understanding and management of tropical diseases not only in Panama but also in the broader region.

Panama's contributions to tropical disease research extend beyond the work of ICGES. After serving as Surgeon General of the U.S. Army, Dr. Gorgas joined the Rockefeller Foundation's Yellow Fever Commission as director of its work on yellow fever eradication. Later, Harvard instructor Max Theiler joined the commission and developed the 17D vaccine against yellow fever. Theiler, a virologist, eventually won the Nobel Prize for his efforts, and the 17D vaccine is still used today, a testament to the enduring impact of Panama's rich history in medical research.

Evolution into ICGES

In 1930, the GML published its first paper, "Preliminary Report on Some Parasites in The Blood of Wild Monkeys of Panama," by Herbert C. Clark (director, Gorgas Memorial Laboratory, Panamá), in The American Journal of Tropical Medicine (Vol. X, No.1. January 1, 1930). This marked the beginning of a long and fruitful scientific discovery and publication journey for the institution.

Over the years, the GML has evolved into the Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES), a leading institution in Panama's medical research landscape. ICGES continues to build upon the rich legacy of its predecessors, conducting cutting-edge research on a wide range of tropical diseases and public health issues. This evolution has positioned ICGES as a key player in Panama's current landscape for medical device trials, particularly in first-in-human and early feasibility studies.

As you explore the advantages of conducting first-in-human and early feasibility medical device clinical trials in Panama, it is essential to understand the historical context that has shaped the country's medical research environment. Panama's rich history in medical research, exemplified by the work of Dr. Gorgas, the establishment of the Gorgas Memorial Laboratory, and its evolution into ICGES, has laid a strong foundation for the country's emergence as an attractive destination for medical device clinical trials.

Current Latin American Landscape for Medical Device Trials

Regulatory Framework

Panama updated its clinical trial regulations in 2019 (Law 84 of May 14, 2019) and received 16 clinical trials and about $3.9 million in pharmaceutical clinical research investments. The country has a three- to four-month central ethics committee review process and has 11 accredited ethics committees. However, Panama may be too small to ensure fast recruitment for medical device clinical trials. It only has five private hospitals in Panama City, with little medical device clinical research experience since the country is mainly known for vaccine trials. Panama is largely underdeveloped outside Panama City, limiting subject recruitment and the site selection process for a medical device early feasibility study or first-in-human study to just the five hospitals in Panama City, with about 1.8 million people.

Paraguay has established a robust regulatory framework for approving clinical studies since Resolution 614 of December 2016. According to local experts, the timeline for a study approved in Paraguay is three to four months, but the time can be shortened to as little as one week with the right government contacts. However, there are industry concerns about corruption in Paraguay's clinical trial regulatory approval process and light oversight of good clinical practices (GCPs). MedTech clinical trial companies that want to have clinical studies above reproach have limited interest in conducting clinical trials in Paraguay.

Colombia's regulatory agency, INVIMA, recently announced to the research community that it is working on updating the medical device clinical trial framework to make the approval process more efficient and align it with its 10-year plan to become a knowledge-based society and OECD best practices recommendations for international clinical research.

Infrastructure and Facilities

Colombia stands out as a clinical trial destination in Latin America thanks to its scientific rigor, ethics, and quality. The World Health Organization (WHO) ranks Colombia's healthcare system 22 out of 191 countries and rates the country's healthcare system as the best in Latin America. Colombia offers the necessary guarantees to conduct clinical research of the highest level by having a rigorous level-4 regulatory agency (the FDA is also a level-4 agency) and strict regulations on this matter. Five Colombian research centers have been classified among the 15 best in Latin America. Colombia is the only country in Latin America with a GCP institutional-level certification to ensure the quality of the clinical data exported from the country. Colombia has 135 certified research centers and 76 institutional and central ethics committees.

Patient Population and Recruitment

Latin America is a less exploited region for patient recruitment compared to major, saturated U.S. and EU centers. Several studies indicate that awareness changes attitudes toward clinical trials, enrollment, and the benefits of participation. In a survey, 85 percent of patients were either unaware or unsure that participation in a clinical trial was an option at the time of diagnosis, and 75 percent of these patients said they would have been willing to enroll had they known it was possible. The lack of clinical trial awareness, drug shortages, difficult access to the national public healthcare systems, and the strong bond between patients and physicians make Latin America a fertile ground for subject recruitment and retention. Also, the large metropolitan areas in the region provide subject concentrations for robust enrollment and retention. These factors explain why experts agree that dropout rates in Latin America are one-third of those in the U.S. and the EU.

With almost 52 million people (80 percent in urban areas), Colombia stands out as a clinical trial destination in Latin America. The clinical trial industry in Colombia expects to reach close to $120 million in foreign clinical research funding inflow and to treat over 20,000 subjects. Experts agreed that Colombia could benefit from over 100 new clinical trials yearly, with nearly $500 million in economic gains per year. Several studies have found that Colombia's level of education, physician-patient relationships, adherence to trial protocols, and patients' enrollment and interest in the research are all perceived as high.

Advantages of Conducting FIH and EFS in Panama

Streamlined Approval Process

Panama's streamlined regulatory approval process for medical device clinical trials is a significant advantage for companies seeking to conduct first-in-human (FIH) and early feasibility studies (EFS) in the country. In 2019, Panama updated its clinical trial regulations with Law 84, which helped create a more efficient and predictable regulatory environment. The country has a centralized ethics committee review process that typically takes three to four months, which is relatively quick compared to other countries in the region. This streamlined approval process can help medtech companies save valuable time and resources when conducting FIH and EFS trials in Panama.

Moreover, Panama has 11 accredited ethics committees, which provide companies with various options for obtaining ethical approval for their studies. These committees are well-versed in the specific requirements for medical device clinical trials, which can help to ensure a smooth and efficient review process. Additionally, Panama's regulatory authorities are known for their collaborative approach, working closely with sponsors and investigators to facilitate the approval process and ensure that studies are conducted following international standards.

Cost-Effectiveness

Conducting FIH and EFS trials in Panama can also be a cost-effective option for medtech companies. The country has a relatively low cost of living compared to many other countries in the region, which translates to lower costs for clinical trial operations. This includes expenses such as site fees, patient recruitment, and investigator payments, which can add up quickly in more expensive locations.

Furthermore, Panama's favorable tax incentives for research and development activities can help offset some of the costs associated with conducting clinical trials in the country. These incentives include tax credits and exemptions for expenses related to research and development, as well as streamlined import and export procedures for clinical trial materials.

Diverse Patient Demographics

Panama's diverse patient demographics are another key advantage for FIH and EFS studies. The country has a population of approximately 4 million people, with a mix of ethnic backgrounds, including mestizo, Indigenous, and Afro-Panamanian populations. This diversity can be precious for studies that require a broad range of patient characteristics to evaluate the safety and efficacy of a medical device.

In addition to its ethnic diversity, Panama has a relatively high prevalence of certain medical conditions that interest medtech companies. For example, the country has a high incidence of cardiovascular disease, which is a significant focus area for many medical device companies. This can make it easier to recruit patients for studies related to cardiovascular devices, such as stents, heart valves, and pacemakers.

Panama's population is also relatively concentrated in urban areas, with approximately 68% living in cities. This can make recruiting patients for clinical trials easier, as many potential participants are located near research sites. Panama's well-developed healthcare infrastructure, including modern hospitals and clinics, can also support complex medical device trials.

While Panama's population is smaller than that of some other countries in the region, such as Colombia or Chile, it can still offer a viable option for companies conducting early-stage clinical trials. The country's streamlined regulatory process, cost-effectiveness, and diverse patient demographics make it an attractive destination for medtech companies looking to conduct FIH and EFS studies in Latin America. As the medical device industry continues to grow and evolve, Panama's role as a hub for clinical research will likely expand, offering new opportunities for innovation and advancement in the field.

Conclusion

Panama's emergence as a promising destination for first-in-human and early feasibility medical device clinical trials has a strong foundation in its rich history of medical research. The country's strategic location, updated regulatory framework, and diverse patient demographics make it an attractive option for medtech companies looking to conduct cutting-edge studies. While challenges exist, such as the limited number of research sites, Panama's cost-effectiveness and streamlined approval process offer significant advantages to explore.

Panama's role in advancing innovative research is likely to grow as the medical device industry continues to evolve. Its unique blend of historical expertise and modern infrastructure positions it well to contribute to groundbreaking developments in medical technology. For those looking to explore these opportunities further, scheduling a Medtech Clinical Trial Consult with bioaccess® can provide valuable insights and guidance. Ultimately, Panama's landscape for first-in-human and early feasibility studies presents an exciting frontier to push the boundaries of medical device innovation and improve patient care worldwide.