Data sharing and privacy are an increasingly important part of an effective modern healthcare system. From early-stage clinical research to screening, diagnosis and patient monitoring and innovative collation and interpretation of data, the sharing of such data is key.

While data protection regulations are bringing enormous positive changes, they also bring limitations to clinical research, especially when the healthcare data crosses international borders.

Clinical trials often involve transferring large amounts of health/clinical personal data across borders. In the EU and the UK, the General Data Protection Regulation (GDPR) has become the gold standard for protecting individuals’ private information, but the GDPR contains several articles that present unique challenges to the pharmaceutical clinical trials industry. However, many of the responsibilities and obligations defined by the GDPR are not new for companies in the clinical research sector, including that of consent.

Informed consent is one of the most critical components of clinical trials and, as part of the GDPR, the conditions for consent have been strengthened – most notably, to make it as easy to withdraw consent as it is to give it.

Several countries have passed their own laws that offer even greater protections for citizens’ data. For clinical trials, this means the GDPR governs the trial activities of all UK/EU subjects, as well as all local and foreign pharma companies and clinical research organisations (CRO), acting as ‘controller’ or ‘processor’ of the personal data of UK/EU subjects.

This adds to ongoing challenges, especially when clinical research is done across international borders. In clinical trials, for example, when synchronous research takes place across different continents, regulations like GDPR could increasingly affect the use and collection of trial data, as well as patient engagement.

GDPR adds complexity to the systems and processes of collecting and processing data, which means that it increases the costs of the research processes that enable new medicines to enter the market.

During COVID-19, we saw how important it was for countries to share information quickly, which was bourne out by the approval, in record time, of the first COVID-19 vaccine. At the same time, the UK’s exit from the EU has not made things easier for the operation of cross-border clinical trials. Currently, the data situation is similar to what it was prior to the end of the transition period, with the UK adopting the majority of the GDPR.

‘From early-stage clinical research to screening, diagnosis and patient monitoring and innovative collation and interpretation of data, the sharing of data is key’

Data reforms are already underway, with the UK government publishing its Data Reform Bill in June 2022, with a package of measures aimed at reconstituting the country’s data policy landscape. While on the surface the proposals seemed significant in many ways, the extent to which this would be reflected was uncertain, especially surrounding the GDPR, given that many businesses might hesitate to change their operations too drastically in order to continue operating in both the EU and UK.

The UK, and the worldwide, clinical trials industry was already complying with most of the GDPR requirements due to strict regulatory requirements (including the FDA, MHRA, PMDA, ICH, GCP, etc) before the GDPR came into force. The main burden of a new data protection system is to demonstrate compliance through updated documentation and policies, and by introducing ongoing checks and controls. To ensure compliance with data protection, some companies are using generalised data protection checklists and documentation without realising that most of the articles are irrelevant to the clinical trial industry. For example, personal data cannot be deleted if it is related to clinical trial subjects. This adds an additional burden and inevitably results in increased head counts, the cost of which is paid by the consumer as the costs are passed on down the product chain.

To understand how efficient data sharing supports faster clinical research, it is important to consider how far we’ve come. In previous decades, paper-based data was the standard and the time taken to process these records meant that there were inevitable delays in the analysis of data and subsequent formal assessments.

With the advent of increasingly sophisticated ways to process the data, scientists can now utilise platforms that share information instantly, enabling real-time assessments of patient safety and trial outcomes. This enables rapid medical decision-making and ensures more efficient studies, with researchers able to make faster assessments of the efficacy of therapies and maintain a holistic view of clinical studies.

For example, at Richmond Pharmacology we recently conducted an internal trial where the trial participants shared their daily health data to allow ongoing assessment.

This resulted in an 80% reduction of heart failure hospitalisations within just five months of monitoring, which is not only beneficial for patients, but also for the NHS, with each complex heart failure admission costing around £6,500. Therefore, efficient data sharing can help make innovative medications available to the public sooner, by safely and comprehensively addressing hurdles to therapies, monitoring or follow-up at a faster rate.

While the data protection framework aims to protect private information about a range of activities, the resulting limits on the ability to assess EU/UK subjects’ health information poses additional burdens in advancing a global clinical research framework and common regulatory policies. The UK adopting a new system may further create a bureaucratic delay for an industry where timing is key.

Medical privacy has been at the core of trial participation for a long time and the clinical research industry is perhaps the most advanced in understanding how to safely handle sensitive personal data.

The impact of the UK diverging from the GDPR and the handling of personal data of study subjects is significant. While it is beneficial for data subjects to have more control of their data, the pharma industry needs to come together and ensure that bureaucracy and processes around compliance with data protection are simplified, as compliance has already mostly been achieved.

Looking ahead, advances in clinical protocol designs, combined MHRA and ethics study submissions, data sharing and visualisation while using experienced CROs to conduct clinical trials will ensure that the general population will be able to benefit more quickly from new life-saving medications. The UK government needs to recognise that facilitating the processes around clinical studies is an important part of becoming a global life sciences partner.

Regulatory changes in the various frameworks around the world are helping the integration of data management tools and the potential benefit for both industry and patients of better data-sharing tools is vast. Unlocking the next generation of data sharing, processing and visualisation in clinical trials will be the next great frontier in pharmaceuticals.