Having recently attended the World Congress of Nephrology (WCN) in Bangkok, Thailand, George Clinical representatives had the opportunity to meet experts and peers from around the world to share ideas and best practices and continue to develop networks that will advance global kidney health. Connecting with communities from different parts of the world not only highlights and identifies global challenges, but also brings regional issues to the forefront.
This is an especially exciting format for countries that are under-represented when it comes to clinical research — those considered to be “emerging countries” that are eager to participate in more clinical trials. Kidney disease knows no geographical boundaries, and neither should the reach of clinical research to deepen understanding and lead to better prevention and treatment strategies for all people in an equitable manner.
Some examples of countries that are emerging as candidates for bringing in an increasing level of clinical research include the Philippines, Vietnam, Sri Lanka, Indonesia, Bangladesh, Pakistan, Thailand, Argentina, Columbia, Brazil, Mexico and multiple countries in Africa.
Addressing Concerns
Concerns have been raised about conducting trials in lower and middle income countries (LMICs), for both sponsors and the patient populations. Sponsors may worry about infrastructure and quality issues — hospitals, physicians, data, etc. — and the regulatory and operational challenges they might face. Concerns around patient populations include protections from exploitation, comprehensive patient education, cultural and clinical differences that might not be respected, and local patients never seeing the benefits of the studied treatments.
While healthcare in emerging countries might not be as advanced as in developed countries, there are many areas where top tier hospitals have standards familiar to sponsors, with many of the healthcare professionals actually trained in a mature clinical trial ecosystem who have returned to their own countries eager to attract trials to their region. Choosing a CRO with “boots on the ground” — local professionals who know and have relationships with qualified sites, local KOLs and physicians, as well as knowledge of regulatory pathways — can quickly alleviate any concerns a sponsor may have about the quality of the research centers chosen and the data being generated.
A globally savvy CRO will connect with the appropriate local site support infrastructure, and through existing relationships with physicians, research facilities and sites, provide a watchfulness over studies that adds an extra layer of protection for vulnerable populations and ensures adherence to international guidelines. They will also provide patients with clear communications in their own language and cultural context for a thorough understanding of a study. This protects patents and benefits sponsors with expedited and optimum recruitment as well as highest retention levels.
Both Sponsors and Countries Reap Rewards
For sponsors, these emerging countries provide a strong and virtually untapped patient pool, allowing for more rapid recruitment of patients most suited for their study and providing greater diversity to clinical trial data. And of course there are cost savings over studies conducted in more expensive regions. Looking beyond the monetary benefits, a sponsor will get a better understanding of the global population — the specific responses different ethnicities may have to diseases and their treatments.
They will also be building relationships with key people in the region that can open doors for them for future clinical development and for more rapid translation of their treatments into local clinical practice. Building ethnic diversity into their drugs will make them more viable in the future and help to democratize advanced healthcare for all populations across the globe. And by strengthening the clinical trial ecosystem globally, we are moving closer to a world where all countries can benefit from drug research and development.
Benefits for the countries and their populations can be great. At the patient level, clinical trial participants get a standard of medical care and treatments that might not otherwise be available to them. They are contributing to data that can help drug developers better understand the differences in disease and drug behavior on their own population. They become more knowledgeable and trusting of the medical community, learn better how to communicate with healthcare professionals, and gain agency into their own healthcare. Ultimately their experience can help to more broadly educate the population as they go back into their homes and communities and share their experience.
At the country level, capacity building is the greatest benefit. More research in these communities helps improve facilities, educate investigators, attract better talent and increase government support. Every study done in a country makes that country better at participating in the next study. Day-to-day clinical practice is also advanced, as even when a study does not meet its endpoints, physicians gain new insights that can incrementally improve the quality of life for their patients.
The ripple effect can also extend to policy changes. Bringing clinical research into a country can have the value of raising their recognition beyond “just another LMIC” — it can help with job expansion and inspire their citizens who have studied abroad to return. When governments see the value of bringing clinical research into the country, it can lead to better policies that make it even more attractive for sponsors. Also, the interaction with global researchers can give local researchers more international visibility and improve opportunities to have their research disseminated to a broader scientific community.
The need is real. The mission is vital.
The need for global equity in clinical trials is real. If drug companies want their products to be effective across the globe, they must do their research across the globe — not just in areas where it’s easiest and most profitable.They then must work to ensure that the people in those areas are also going to benefit from the research and have the treatments available to them. Inclusive global registries need to be built that provide critical information to support research that is truly addressing a need and can support prevention, detection and treatment of the chronic diseases that are prevalent across the world.
George Clinical supports the vital mission of more inclusive clinical research to provide a more equitable distribution of advanced treatment options throughout all populations. Our global network of scientific leaders and clinicians share insights and successful methodologies with one another to help researchers in various countries to be better equipped and more responsive to clinical trials. In the end, our dedication is to the patients around the world who all deserve to benefit from the rapidly advancing treatments for kidney and other chronic diseases.
