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Highlights
- There is a rise in globalized clinical trials which necessitates international data transfers.
- With outsourcing of clinical research and development (R&D), international data transfers have become indispensable.
- Pharma companies need to ensure regulatory compliance in international data transfers during clinical R&D.
In this article
In this article
Globalized clinical trials
With the rise in globalized clinical trials, the pharma industry needs to ensure compliant international data transfers.
We are seeing changing regulations in clinical R&D, which promote increased efficiency, transparency, and inclusion of clinical trials. These evolving regulations also incentivize and offer benefits from global clinical trials—where only 31% of clinical trials registered on clinicaltrials.gov are US-only trials. And, in Europe, multi-national clinical trials comprise more than 29% of the continent’s clinical R&D sector. Moreover, these regulations create a self-sustaining virtuous cycle that maximizes the societal and economic benefits of R&D in pharma.
However, globalized clinical trials increase sponsors’ exposure to associated risks and unforeseen challenges. The primary challenge is navigating complex regulatory landscapes of jurisdictions in which trials are conducted. Although clinical trials are based on the universal aspects of the scientific method, they simultaneously represent complex projects with multi-faceted medical, societal, and legal aspects that are differently perceived and not uniformly regulated across various jurisdictions.
What’s more, clinical research collaboration or outsourcing is made possible with seamless data transfers on a real-time or daily basis. This enables transferring data to partners across borders making globalized clinical trials possible. With international data transfers being indispensable to globalized clinical trials, how can companies ensure compliance with its requirements?
Outsourcing clinical R&D
Clinical R&D outsourcing is projected to continue growing at 11.4% CAGR to reach a market capitalization of $91B by the end of 2026.
This exponential increase in outsourcing clinical R&D has given the drive to conduct trials on a global level. Outsourcing clinical R&D has become inevitable as it increases efficiency and controls the already massive spending that is required to get new drugs to the market. Like most businesses, the power law of 56% of the virtually-hyperconnected world has shaped the clinical outsourcing landscape. This means that for most data-oriented services a ‘winner-takes-all’ reality prevailed, with best-in-class suppliers becoming the trusted outsourcing partners of pharma companies.
The migration of clinical R&D data to the cloud has given a huge edge to the rise of globalized clinical R&D service providers. This enables one to transcend international borders with the centralized, upscaled, and specialized processing and barrierless transfers of data, resulting in improved efficiency and reduced costs of clinical R&D.
Hence, this free flow of data maximizes economic value of clinical R&D. In addition, it offers unprecedented scientific opportunity to simultaneously conduct trials on a larger, more inclusive population, resulting in more statistically powered results. That’s not all. It also helps in getting much needed treatments to the international market at unimaginable speed. The international rollout of COVID-19 vaccines at record speed is a compelling example of how fast things could get when barriers are overcome.
Regulatory obstacles
Data protection and varied perceptions of the privacy of clinical subjects hinder regulatory harmonization.
Medical regulatory bodies have recognized the enormous advantage of globalized clinical R&D. They support and endorse unified frameworks to regulate clinical trials. For instance, the Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory authorities adapt the International Council for Harmonization’s (ICH) good clinical practices (GCP). Moreover, regulators are keen to make clinical trials and their results globally and readily accessible through centralized registries such as FDA’s Clinical Trials online system.
While huge strides have been made in harmonizing the medical and scientific rules that underpin clinical trials, certain societal and legal aspects are recalcitrant to global consensus. The topmost concern lies in patients’ right to privacy and the adoption of mandatory measures to protect sensitive data on personal health. Unlike scientific and medical matters which are objective, the sense and boundaries of personal privacy are highly subjective issues which are differently perceived across countries and societies. This leads to high complexity and contrast in the international regulations on privacy and protection of personal data, including data transfer regulations and compliance prerequisites. To top it all, the applicable laws in each jurisdiction are subject to dynamic changes, which reflect the evolving politics, public opinions, and culture of different countries.
Data transfers, which are the bread and butter of clinical R&D collaboration, are governed by laws and regulations of data privacy, protection of both exporting and importing jurisdictions and relevant agreements between them. In other words, data privacy and protection regulations are now to clinical trials what customs and trade regulations have always been to international trade. Nowadays, international data transfers are usually required to collaborate with best-in-class clinical R&D service providers, even when the actual patient recruitment and treatment occurs in one country or jurisdiction.
Compliant data transfers
Driving regulatory compliance in clinical R&D data transfers.
European pharma sets a strong example for a market with huge demand and potential for regulatory compliance in data transfers. This is largely due to the European Union’s (EU) extensive personal data privacy and protection rules. The EU categorizes jurisdictions based on their perceived safety to the personal data of individuals in EU and legal protection of data transfers. It foresees legal and technical protective measures that dynamically evolve to cope with the ever-increasing data flow in a digitalized world.
For TCS’ European pharma clients, compliant data transfers are essential for supporting multinational clinical trials that represent 29.2% of ongoing clinical R&D activities. However, this is only a fraction of the larger number of clinical trials that require international data transfers to enable outsourcing. Nowadays, almost every major clinical trial requires international data transfers to one or more service providers. What’s more, seamless international data transfers are essential to ensure international market access. For European pharma, that represents over 76% of its overall market, which are export markets outside Europe.
The way forward
Make the best use of a trusted services provider for seamless data transfers in clinical R&D.
To ensure seamless international data transfers in clinical R&D, pharma companies need to collaborate with a capable service provider like TCS. TCS’ wide engagement with pharma majors and contextual and technical capabilities drives regulatory compliance of clinical data transfers from and to EU partners. We offer a wide portfolio of IT services, integrated approach to consulting, service delivery, and shared experiences for pharma companies across markets.
Moreover, systemic solutions for compliant international data transfers will enable data sharing and access beyond clinical trials, covering health and wellness data. We envision a Health Data Marketplace (HDM), for instance, as a single point of access to health and wellness data. This will enable data and analytics as a service and promote data democratization to harness big data and hyperconnectivity for individuals’ wellness and transform the business model for healthcare and pharma.
With a remarkable presence in 55 countries, and as a leading excellence partner for pharma and life sciences, to tackle the regulatory challenge of international data transfers in clinical R&D through tailored, contextualized solutions. This will enable compliant and seamless data transfers, along with data democratization, for pharma companies in clinical R&Ds.
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