Opportunities and challenges in access, collaboration, technology, and regulations
Nino da Silva is Deputy Managing Director and Chief Commercial Officer at BC Platforms. BC Platforms is a technology provider and trusted advisor to healthcare, biotech and pharma organisations. Its modular, highly configurable data access platform, combined with its federated Global Data Partner Network, and 25+ years’ pioneering work in data management and analytics solutions for healthcare, provides a strong backbone for global collaborations that are driving important advances in healthcare research.
Evidence-based medicine is going through a transformation, moving towards a patient-centric system with real-world data (RWD) at its core [1]. Generated by routine, patient standard-of-care, RWD has also allowed clinical trial research to better represent ‘real-world’ scenarios and allowed the use of data beyond that from randomised clinical trials, such as virtual patient cohorts.
With most of the genomic datasets currently available being mainly from European ancestries as of mid-2021 (86%) [2], recent advances have helped drive a need for more diverse patient data in basic research and drug discovery and development, including RWD.
Across the world, countries and their markets are at different points in their relative maturity in terms of their approach to RWD – from sequencing individuals’ DNA and acquiring genomes to ensuring high data quality, privacy and ethics and enabling secure, international data sharing. One important question is whether there is a solution which can overcome the challenges to provide exciting opportunities for safe and secure data sharing across borders, while also maintaining trust and transparency.
In a recent panel discussion with several international experts across three different continents – Prof. Tõnu Esko, University of Tartu, Estonia, Prof. Collen Masimirembwa, African Institute of Everyone Genome, South Africa, as well as Associate Prof. Teeradache Viangteeravat, Bumrungrad International Hospital, Thailand, I discussed market maturity and its impact across different regions. We looked at technology and regulations as well as roadblocks to collaboration between institutions, nations, and continents.
Africa – A revolution in RWD generation, access, and sharing
The African continent and its 1.2 billion people represent some of the most diverse ethnic populations on Earth. Most healthcare is delivered through public systems, and in a country like South Africa, treatment options can be more like in Europe or the US, with access to diagnostics and medicines, as well as data collection. In other African countries however, the focus, and therefore data collection, is often related to HIV, TB, and malaria infections, i.e. infectious diseases, because these are run under well-funded national programmes.
Across most of the African continent, non-communicable diseases have fewer funding avenues, and, therefore, fewer organisations have been developing infrastructure and centres for monitoring and recording data. Laboratory infrastructure remains weaker, although there is a focus on building capacity in this area. The African Institute of Everyone Genome also hopes to address this need with RWD research into over 10 million consenting patient genomes from the African continent over the next 10-15 years, to enable drug development and clinical research for patients in sub-Saharan Africa.
Even in South Africa, where the approach to data collection is more often collected as part of the standard of care, the mobility of the population, especially in the case of longitudinal studies, can be a challenge, as well as the consistency and transfer of electronic patient record systems for patients who have moved to another part of the country. There is also a need to drive further public awareness about the value of any data generated, and to be aware of national guidelines.
Africa’s genomic diversity is an asset, with the range of infectious and non-communicable diseases posing a significant challenge to modern medicine. Obtaining multiple types of phenotypic data can also be a challenge, with imaging, X-rays etc. not always accessible in the public sector.
Thailand – Trust, infrastructure and data quality are key
In Thailand, there is a large public hospital system, although the private sector has been thriving, driven by a sharp increase in medical tourism. Government policies have developed over the years to accommodate this demand, in addition to heavy investment in Thai healthcare infrastructure. This includes data infrastructure, including a biobank and the generation of genomic data.
Across Thailand, there are also recognition and efforts to improve the levels of high-quality data obtained and the standardisation of electronic medical record systems, to facilitate information exchange and support longitudinal data collection that can fuel research and discovery.
Thailand also has its new personal data protection act (PDPA) regulations, which have been significantly influenced by GDPR and came into place in June 2022. These regulations are more comprehensive and in line with the changing digital age to protect Thai citizens’ personal data, and gives them their right to privacy. This has reassured Thai healthcare providers’ perspective on the way patient’s data need to be protected, securely managed, consented and fully anonymised prior to using them for research and discovery. How data can be shared safely and securely has become paramount, as is being able to do this in a timely manner. Ultimately, data sharing comes down to trust, transparency, and building strong relationships.
Estonia – A need for improved global collaboration and data sharing
From the Estonian point of view, which can partly reflect the broader European situation, most healthcare is delivered by the public sector. Estonia sets itself apart as being a country with the broadest implemented electronic support for government health care, public services, and structured data as part of electronic patient records, with a sophisticated data infrastructure and a 20-year-old biobank.
Estonia might have a small population, of only 1.5 million people, but it has RWD that researchers and drug companies can learn from and develop products with, and, the ability to implement healthcare services based upon this research and development. This includes state-level precision medicine programmes that focus on pharmacogenomics, how drugs are prescribed, and disease prevention.
Despite the advantages we have in terms of digital advancements, advanced public healthcare system and small population, challenges remain, including the gathering of data as well as effective data sharing, locally as well as globally. An IT infrastructure that seamlessly connects genomic data with everyday clinical practice would also be ideal.
Estonia often lacks enough patients to run very large patient studies on its own, for example, for large cancer studies. That’s why it’s imperative to collaborate with other partners in Europe, Asia, and Africa, and to be able to navigate the laws and regulations in each of these regions.
The solution – a safe and secure Global Data Partner Network
Many of BC Platforms’ data partners are keen to generate and permit access their diverse RWD with a trusted and transparent global network, driving collaboration and accelerating discovery to benefit society as a whole, as well as their own country or region. The Data Partners are keen to see their data successfully used by industry to help drive better patient care and treatments, including precision medicine, while maintaining safety and security that meet all required government regulations and ensure patient privacy. Accessing the data without physically sharing actual data is also important, where these ‘data partners’ can feel they have control over where their data is used, and by whom.
BC Platforms’ growing Global Data Partner Network, including 36 data partners in 25 countries across Europe, the Americas, Middle East, Asia-Pacific, and Africa, with access to 65 million patient lives that meet both GDPR and HIPAA regulations. Our foundational infrastructure and legal pathway deliver patient-level RWD data with an unprecedented breadth and reach.
At BC Platforms, we’ve endeavoured to revolutionise drug development and personalised healthcare for over 25 years, placing the patient at the center of care. Ultimately, by delivering safe and secure data access and infrastructure, we are helping to address unmet medical needs and reduce the global patient burden for healthcare systems everywhere.
References
Subbiah, V. The next generation of evidence-based medicine. Nat Med 29, 49–58 (2023). https://doi.org/10.1038/s41591-022-02160-z.
Fatumo, S., Chikowore, T., Choudhury, A. et al. (2022). A roadmap to increase diversity in genomic studies. Nat Med 28, 243–250. https://doi.org/10.1038/s41591-021-01672-4.
Brits, E. Sequencing of African population to enhance genomic dataset for disease diagnosis. Nature (2023). https://doi.org/10.1038/d44148-023-00036-z.