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Clinical Research

Globalising Clinical Trials

Pharmaceutical companies are increasingly embracing the need for running trials across multiple sites globally. The rise of personalised medicine, and its promise of improving the drug development process and focused, faster approval of new therapies, places the industry firmly at the centre of the global genomics initiative. But capitalising on it requires a combination of technologies supported and enabled by increased collaboration among the industry, academia and healthcare providers. Pharma needs data and, as the unprecedented opportunities for data collection improve – from technologies including apps, wearables, sensors, telemedicine, electronic patient records and other medical devices – the industry must become increasingly digitised and collaborative.

By 2020, it is predicted that 601 million connected wearable devices will be in use, up from 97 million in 20151. This explosion in the number of people taking charge of their own health is creating an unprecedented opportunity to transform the pharma industry by enabling data sharing that supports the entire R&D value chain. However, this is only achievable through multidisciplinary research collaborations. By definition, global clinical trials are “large-scale trials conducted across populations from multiple countries to enable high-quality, unbiased outcomes”2. Such undertakings inevitably require new approaches to data transparency and collaboration. At the interface between pharma and healthcare systems, as well as in the pre-competitive world of basic science, complex collaborative approaches have already emerged as a robust strategy for exchanging data and knowledge. And while our increasingly data-driven world is broadening opportunities for innovation and disruption, 66 INTERNATIONAL PHARMACEUTICAL INDUSTRY

complexities remain in harmonisation, integration, communication and sustainability.

organisations in these innovations, so that local academic and clinical productivity rises.

Looking beyond the R&D pipeline, globalisation also means that drugs can potentially be marketed in many healthcare territories – can the lessons of data-driven collaboration help scale the necessary regulatory approvals and delivery across multiple localities?

Clinical trial managers should therefore design their programmes to work with local regulators and address ethical concerns. Building on ethical principles outlined in the World Medical Association’s Declaration of Helsinki 3 and the Belmont Report4 among others, a 2000 paper by Emmanuel et al. 5 theorised seven key requirements that must be met for clinical research to be considered ethical, including: (1) value; (2) validity; (3) fair subject selection; (4) favourable risk-benefit ratio; (5) independent review; (6) informed consent; and (7) respect for potential and enrolled subjects of multi-regional clinical trials. These requirements are universal and applicable to any population or site. However, their application requires open and transparent discussion to ensure that trials are seen as fair, necessary and beneficial to the local population, and this should be a key concern of any multi-site trial.

1. Understanding Differences in Populations Genomics and research in personalised medicine increasingly make sense of the differences across populations and individuals. Safety and efficacy of a compound may vary significantly, depending on genetic make-up. Clinical trials rightly restrict the inclusion and exclusion criteria to manage the statistical validity of results. In a global market, this may come at the cost of transferability of results between regulatory territories with distinct populations. It may also be the case that a more genetically varied population provides better insight into individual variability early on, providing greater information gain in the long run, or driving earlier (cheaper) failure. 2. Emerging Markets, Emerging Regulators In emerging markets, a local regulator may be more sympathetic to data gathered, at least in part, in their territory. As well as having 'genetic' relevance to their population, local trial data would indicate that local factors have been considered. These might include availability of diagnostic tests, distribution channels, and clinical expertise that accompany modern complex therapeutics. In territories with strongly interventionist governments there may be increasing demands for pharma to involve, and therefore educate, local clinical teams and healthcare

3. Globalisation: A Key Risk Factor It is widely acknowledged 6 that globalisation has also led to rises in westernised diseases, without the necessary healthcare infrastructure to respond to an increasing burden of chronic disease. Diabetes prevalence in Europe stands between 5% (Scotland) and 13% (Turkey), whereas in the Middle East prevalence rates of 20–25% are not unknown. In 2014 the World Health Organisation put China’s prevalence at 9.4%7. Regionally, in Guangdong China, this is currently estimated at 15%. The increased burden of disease in emerging economies provides a ready market for existing drugs. This will drive localisation of previous trials, attempting to replicate results. However, it also highlights the need to build on any Autumn 2017 Volume 9 Issue 3