LATAM's Regulatory Framework For Medtech Early Feasibility Studies

U.S. medtech companies are increasingly searching for a destination where they can recruit patients faster, easier, and cheaper for their early feasibility studies. Medtech companies want to avoid the uncertainty of the FDA Investigational Device Exemption (IDE) review process. Due to the new European Medical Device Directive (MDR) 's difficulties since May 2021, the medtech clinical trial pendulum is shifting from Eastern Europe to Latin America. Many more medtech companies are now looking at Latin America as their destination for their early feasibility research instead of Eastern Europe.

Latin America's Landscape For Medtech Clinical Trials

This article examines the need to conduct medtech clinical trials outside the U.S. and explores the growth of these trials in Latin America, particularly in Colombia and Paraguay. I will address critical success factors and provide recommendations to ensure cost-effective, ethical, and quality EFS and FIH medtech clinical trials in the region.

The Opportunities For Conducting Vaccine Clinical Research In Latin America

This article discusses the 101-year history of vaccine research in Latin America, how Latin America could help solve the vaccine clinical trial diversity problem in the U.S., and why the region is a desirable destination for such clinical research.

Latin America: A Compelling Region To Conduct Your Clinical Trials

This article examines the need to conduct clinical trials outside the U.S. (OUS), addresses the recruitment crisis in the U.S., reviews the incentives for clinical trials overseas, and explores the growth of clinical trials in Latin America. We will profile Colombia as an example of a country committed to attracting more foreign investment in clinical trials.

4 Time Variables that a Medical Device Company Must Evaluate to Start a First-In-Human Medical Device Clinical Trial in Colombia

The time it takes to approve a clinical research study in Colombia has four main variables. The first is the search for the principal investigator (PI) and his/her associated hospital where he/she practices and has the right patient population (aka IPS in Colombia). The second is the approval time of the ethics committee associated with the IPS. The third is the approval time in the regulatory agency (INVIMA), and the fourth is the approval time of the import permit of the devices under investigation (VUCE). In this blog post, we will explain the reason why the selection of the principal investigator is really what could make a study successful or not.

Three Steps for a Medical Device Startup to Run a First-In-Human Clinical Trial in Colombia and Gather Quality Data at a Fraction of the Cost

Colombia's Ministry of Health (MoH) has one of the fastest regulatory approval times in Latin America: 30 days. The country also boasts a top-performing universal healthcare system that covers about 95% of its 50-million population and competitive hospital fees that are about 30-50% less than in the US or other Western European countries. The EC and INVIMA will evaluate the study protocol, the investigator's brochure, the patient informed consent form (ICF), the case report form (CRF), all information about the investigational product (e.g., biocompatibility tests, reports of unexpected adverse events), the study insurance policy, and all advertising material planned to recruit patients. You must also apply for an import permit at VUCE (Ventanilla Única de Comercio Exterior) —an office within Colombia's Ministry of Commerce, Industry, and Tourism (MinCIT).

Should You Conduct Your Medical Device Clinical Trial In Latin America?

According to ClinicalTrials.gov, device trials have increased 94 percent from 2012 to 2017. The medical device contract research organization (CRO) market is expected to continue growing at 11.5 percent per year; at this rate, the market could reach nearly $13 billion by 2033.

Latin America has seen an explosive growth in medical clinical trials. According to ClinicalTrials.gov, out of the 35,780 global medical device trials conducted since 2000, 1,219 of them (or 3.4 percent) were registered in Latin America.

The same ClinicalTrials.gov data reveals that from 2000 to 2010, there were 255 medical device clinical trials in Latin America; there were 891 from 2011 to 2017 — an impressive 249 percent growth.

Sinopsis de protocolo de investigación para un ensayo clínico con terapia génica transcriptasa telomerasa reversa humana (hTERT) asociada a un adenovirus (AAV) en la enfermedad de Alzheimer

Se trata de un ensayo clínico en único centro, abierto, en donde se evaluará la seguridad, eficacia y actividad del AAV-Htert administrado por vía Intratecal (IT) (Tratamiento A) o vía intravenosa (IV) (tratamiento B). Se realizará una evaluación de la actividad de la terapia AAV-Htert para establecer una dosis proporcional, además de recopilar información sobre la seguridad de los pacientes, así como cambios en el estado basal de la EA. Se incluirán sujetos entre los 40 y 100 años inclusive quienes recibirán uno de los dos tratamientos al inicio del estudio. Los sujetos se evaluarán clínicamente por un año, asistirán a 10 visitas en total incluida la visita de tamizaje y serán evaluados de manera posterior después de finalizar el estudio, mediante chequeos anuales de seguridad para evidenciar eventos adversos tardíos.

Why Gene Therapy Companies like Libella Gene Therapeutics are Looking at Colombia for their Clinical Trials?

Libella Gene Therapeutics —a US-based company— recently chose Colombia to conduct a phase I clinical trial that could represent a breakthrough in the treatment of Alzheimer's disease (AD) using gene therapy. The approval of a gene therapy trial in Colombia takes 30-45 days from the date of submission to an ethics committee. This time may be shorter or longer depending on how fast the ethics committee at the health institution (aka research center) evaluates the study documents. This positions Colombia as one of the countries with the fastest approval time (and lowest cost) in Latin America for gene therapy research.

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