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利用精准医药推进拉美地区的临床试验
作者：Fortrea
In our ongoing efforts to increase diversity in clinical research and help enhance patient participation, our team at Fortrea recently hosted a client symposium in São Paulo, Brazil. We’d like to share four key insights from the symposium, which covered our collaboration with Biomakers, a molecular and genomic testing company headquartered in Argentina with three genomic testing laboratories in the region (Argentina, Brazil and Mexico).
1. Recognizing the urgent need for increased clinical trial access in Latin America
Approximately 8.5% of the world's population lives in Latin America (LATAM) but less than 5% of today's clinical trials are active in this region. Focusing on oncology clinical trials, LATAM patients are underrepresented in multinational tumor biobanks and new cancer therapies are often developed without LATAM-based participants.
Furthermore, an estimated two-thirds of the cancer patient population in LATAM do not have access to predictive genetic testing. Given that the majority of new cancer treatments are developed with the support of genetic data, Fortrea and Biomakers partnered to increase patient access to diagnostic molecular profiling and boost participation in clinical trials.
2. Understanding why Latin America represents a desirable clinical trial location
Drug development sponsors consider LATAM as a desirable location in an international clinical trial due to its ethnically diverse population and established doctor-patient relations, among other factors.[1] Patient recruitment in these so-called “emerging” regions is considered easier and faster than industrialized “Western” regions, and motivated investigators are eager to participate and publish results.[2] In countries that have national universal healthcare systems, access to healthcare may be delayed, which results in more patients interested in participating in clinical trials.
3. Combining real-world data and a pre-screening program to identify potential trial participants
As physicians order genomic testing and record clinical data from more than 10,000 new patients each year, Fortrea and Biomakers are gathering this molecular characterization data to populate a database that includes retrospective data for statistical analyses.
In this "live" database, potential investigators, sites and patients can also be evaluated for participation in a clinical trial. Coupled with the development of a large patient referral network, the patient screening and enrollment process has the potential to become more streamlined.
4. Bringing more diversity to clinical trials—and advancing precision medicine treatments
With this multi-faceted approach, which increases genomic testing, captures clinical data and implements an innovative pre-screening process, more patients across Latin America can participate in global clinical trials. Together with Biomakers and global drug development sponsors, we believe thesse collaborative efforts will also help incorporate the diversity of LATAM patients in global clinical trials and lead to more precision medicine treatments for people living with cancer, both in LATAM and around the world.
Learn more about our support of life-changing clinical research at https://www.fortrea.com
1. Pinto, Manuela Fernández. Doubly Disadvantaged: The Recruitment of Diverse Subjects for Clinical Trials in Latin America. Tapuya 1 2019 (2):391-407.
2. Strüver V, Ibeneme SC. Why are emerging countries popular for clinical research? S Afr Med J. 2021 Apr 30;111(5):453-459.
