How Medtech Companies are Unlocking the Potential of Latin America in Clinical Research
Source: The INTERNATIONAL BUSINESS TIMES
03/07/24 AT 4:39 PM EST
Over the past two decades, clinical research has shifted from Western countries to emerging low-income and middle-income countries (LMICs) in Eastern Europe, Latin America, and Africa, with offshored R&D activities from the US, Europe, and Japan gaining attention. Studies challenge the traditional cost-related reasons for offshoring clinical trials, emphasizing the importance of recruiting human subjects in trials faster.
Latin America attracts clinical trials due to its faster and easier patient recruitment, diverse population, and strong doctor-patient relationships. In 2020, there were 67 medical device trials in Latin America, a 67.5% increase from 40 in 2017. Colombia, one of the countries attracting more Medtech clinical trials in the region, is updating the medical device clinical trial framework to make the approval process faster and more efficient.
The availability of many FDA-approved palliative therapeutic options in the US prompts patients to be cautious when participating in trials with unproven therapies, particularly in phase I or first-in-human studies. Moreover, life science startups need more fast access to investigators at hospital systems and universities for clinical trials and also complain about the uncertain regulatory pathway to approve a first-in-human study at the FDA.
The national government of Colombia has been making efforts with its 10-year plan to strengthen the processes of science, technology, and innovation in the country over the years, along with the case study contributed to the Organisation for Economic Co-operation and Development (OECD) TIP Knowledge Transfer and Policies project, aiming to organize and improve the organizations and processes involved in these activities. Colombia, one of the only four OECD members in Latin America and one of the only three countries in the region with a vision to become a knowledge society by 2032, has a National Science, Technology, and Innovation System that promotes inclusivity, accessibility and classifies research groups based on excellence. Social appropriation in science involves linking individuals to scientific processes, creating knowledge communication strategies, and developing pedagogical strategies. With these initiatives, Colombia seeks to attract more US Medtech startups to transfer advanced knowledge to local investigators and collaborate in clinical trials.
