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Regional factors impact direct-to-patient modalities and bring the benefits of DCTs to life.
The pandemic gave the research industry the workflows and infrastructure to address some of its biggest challenges, including recruitment, retention, patient centricity, research access as a care option, and more. And in Latin America, addressing these needs together with the desire for higher enrollment, positive patient experiences, and more diverse patient populations provided study sponsors a favorable investment option to conduct research. But with all its advantages, there were challenges to scale studies that technology alone is unable to overcome. The transformative ingredients to advancing decentralized studies in Latin America are regional access to key stakeholders (i.e., virtual principal investigators, patients, and communities), plus localized infrastructure, ecosystem expertise, and staff recruitment that scales to achieve broad regional diversity.
Patient centricity in clinical trials has long been a common goal of the industry. The aim is always to work in the best interest of trial participants. This is especially true for patients in Latin America who are afflicted with diseases. If the key to the pursuit of cures and therapies requires these limited patient populations as trial participants, then it should not come at the expense of burdening their lives. Direct-to-patient trials expand recruitment into all reaches of Latin America while alleviating many downsides to enrollment.
Patients with rare diseases, cancer, and other maladies have obvious limitations. These challenges include physical, financial, and personal support restrictions that impede travel to sites. The hindrance of distance is a familiar factor. Typically more than 70% of trial participants live more than two hours from sites (source: Sanofi). But in Latin America, there are more complicating factors that impact transportation. In 2021, the number of vehicles per capita in this region was approximately 0.22, or 220 per 1,000 people. Compared to rates of more than double in Europe (0.52) and North America (0.71), combined with the lack of transportation infrastructure in urban zones where 80% of the population resides, the ability to cover distance is a socio-economic challenge that is exponentially more difficult in Latin America than in other regions.
“The challenges can stack up,” said Diogo Lopes, Chief Nurse, Hospital Infantil Candido Fontura, and Decentralized Clinical Trial Project Manager in Brazil. “The reasons that patients are unable travel to clinical trial visits are the same reasons that make home visits challenging.”
Road conditions, lack of clearly marked streets and no addresses, limited or aging vehicles, and the sliding scale of increased difficulties for transportation access as you travel from urban to more rural areas. This makes the viability of direct-to-patient trials that use home health services a modern success story of clinical trials in Latin America. “I mean how do you find and access a house on stilts in an Amazon community that floods during certain times of the year? How do you perform a visit in a favela where outsiders are not tolerated? The only chance of success is a local decentralized trial organization with the experience, infrastructure, and nurses [with the right dialect and who are known to these closed communities],” said Lopes.
Of the benefits for conducting research in Latin America, the access to a deep and diverse patient population are among the keys to successful patient recruitment and enrollment—especially in the case of rare disease and pediatric studies. Providing in-home health, centralized mobile nursing locations, or temporary mobile site services that suitably address transportation limitations are increasingly important to the success of patient enrollment and retention. But the factors for successful enrollment are multi-dimensional.
While these benefits may seem universal across global clinical trial modalities, the added value of sending care providers to patient homes in Latin America is a differentiator. “Patient populations see access to research the same as a care option. Plus, trustworthy patient-physician relationships in this region present a more willing population to participate in clinical trials,” said Dr. Tamara Newman, Infectious Disease Physician and Clinical Researcher at Centro de Pesquisa Clínica, Hospital Dia Instituto de Infectologia Emilio Ribas in São Paulo.
Because the region is still developing, the prospect of gaining access to care carries significant weight for patient populations willing to participate in clinical trials. This enables patients to obtain novel drugs that they could not otherwise access in a healthcare intervention. The prospect of participating in trials is also less encumbered by concerns about research than you might see in the United States. “With decentralized trials and the ability to perform home visits, we have expanded our care from only those who live in or can travel to Mexico City, to patients across the entire country,” said Dr. Susana Monroy, Medical Geneticist and Clinical Researcher at Instituto Nacional de Pediatria in Mexico City. “Patients in Mexico need medical attention and are eager to join clinical trials, and now physicians and Investigators, like myself, are able to provide this to the most challenging patient populations, including pediatric rare disease patients.”
In Latin America, patients also develop strong relationships with their physicians. Many patients live in the same region, use the same hospital, and have the same doctor from birth to death. “We have enthusiastic investigators who gain captive patient populations. Their high level of involvement, even when it comes to in-home trials through home health providers, makes recruitment and retention easier. The culture of trust and eagerness between patients and physicians is probably one of the most unique strengths of conducting research in the region,” says Monroy.
Many sponsors and CROs fully understand the benefits of access and recruitment associated with decentralized trials in Latin America. But when it comes time to execute clinical research, there is one common pitfall: lack of infrastructure. The ability to scale an effort over distance and multiple countries requires a boots-on-the-ground staffing and logistics strategy.
“Direct-to-patient trials that cover vast geographical and rural areas require extensive resources and a sophisticated coordination effort. You can’t parachute infrastructure into a region. Considering it takes hundreds of drug deliveries and visits staffed by local GCP-trained nurses to administer those drugs and a trusted source to harmonize the study between patients, investigators, and care providers—infrastructure that empowers logistics is what makes the difference,” says Paloma de Almenara, Director of DCT Services at H Clinical. "But beyond personnel, medical equipment such as infusion pumps are not always readily available in Latin America, like where I live in Peru. You also must manage regionally but operate locally—you can’t simply ship supplies between countries. This does not work because in Argentina, for example, each imported nursing item can be held up in customs. Even bandages in a phlebotomy kit requires inscription, which is time and cost prohibitive.”
Applying the infrastructure to enhance trial management logistics reduces costs for study sponsors through efficiencies. But how does it impact patient centricity in Latin America? The key is a diverse local workforce. If you employ regional considerations to your decentralized trial strategy, you will better understand what is culturally appropriate, sustain an ethos of trust, and improve patient experiences. This translates to patient engagement and retention in a region with the capacity for higher enrollment.
Achieving a greater level of effectiveness with well-orchestrated regional infrastructure that supports cultural diversity and inclusion is a game-changer. The ability to simultaneously accomplish this across the vast majority of Latin America will lead to smarter clinical research, better care coordination, and transformative patient centricity.
Mitchell Parrish, President, H Clinical