Keeping trial data alive

By Chris Sigley

In 2020, the pharmaceutical industry has been obliged to rise to the challenges of COVID-19. The disruption has been huge, but – as in other industries – the pandemic has accelerated the crucial process of digital transformation that was already underway.

As Paul Hudson, Sanofi’s chief executive, wrote in Fortune in January: ‘As we enter the new decade, pharmaceutical leaders are envisioning a new era of innovation, one in which the discovery of life-saving treatments, enhanced patient experience, and improved overall health will be driven by the transformative power of digital technology.’ By August 2020 a report from McKinsey was exhorting pharma leaders to ‘focus on their crisis response’ and on ‘increasing resiliency and better adapting to the post-COVID-19 world,’ asking ‘As the increased adoption of digital tools, telehealth, and app-based ecosystems make patient-level data available, how will your organisation adapt its operating model and who will be the driver of change?’

This summer, with the aim of gaining insight into the conduct of clinical trials and, in particular, the management and archiving of trial data, a survey of life sciences professionals was commissioned by Arkivum in collaboration with Phlexglobal and the Ethical Medicines Industry Group (EMIG). Among the key findings, 70% of the 200+ respondents said that COVID-19 has triggered a change in the way clinical trials will be conducted. There can be no doubt that digital technology – encompassing such innovations as wearable technologies and artificial intelligence – will play a key role in that change, both when it comes to the collection of data and in the way it is subsequently analysed and stewarded.

Paul Hudson also said that: “As it stands, the pharma industry lags behind other highly regulated industries, such as banking and insurance, when it comes to successful digitisation.” That is a topic for another day, but our survey found that no fewer than 90% of sponsors and clinical research organisations (CROs) have already adopted an eClinical application to improve study execution and data collection in live trials, while 36% of sponsors and 48% of CROs now use purpose-built digital applications to manage the trial master file (TMF). In other words, the paper TMF has, over the past 10 years or so, largely been superseded by the electronic TMF (eTMF) a tool more commensurate with the demands of a digitised world and ever-growing volumes of data.

The TMF is, of course, a central discipline of drug development and key to any marketing authorisation application (MAA). It constitutes a structured and closely regulated repository for clinical trial data and provides evidence of the good practice implemented by stakeholders in the trial. The integrity of clinical trial data must be ensured in the TMF/eTMF over the period of the trial itself and subsequently, for a minimum of 25 years, in an archive, which can be subject to regulatory inspection at any time.

As ever, regulatory compliance is rightly a top priority, but a well-curated digital archive can also offer an opportunity to look at things differently. It can open the way to much wider benefits throughout the product life-cycle, proving of value in matters of pharmacovigilance, value-based pricing and reimbursement, and in the quest for new indications and formulations.

On the corporate side, it can play a role in licensing and partnership opportunities, in handling legal challenges and due diligence, and in mergers and acquisitions.

Essentially, the TMF is a body of data too valuable simply to lock away in the archive until there is an audit, an inspection or a question about compliance. Beyond meeting regulatory requirements, an indexed, searchable, interoperable, discoverable digital archive can become a knowledge repository for an entire organisation. It can create efficiencies, enhance collaboration and avoid duplication of previous effort when the search is underway for new applications and indications for an existing treatment. It can provide the answers to such questions as ‘Did we do this work previously?’ or ‘What did we find last time?’ All in all, a dedicated, secure digital archive can enhance an organisation’s ability to exploit the often hard-won knowledge that it already has.

When it came to the question of archiving, the survey found 70% of sponsors reporting that they use a digital archive rather than the traditional paper-based option, while 45% of respondents cited the role that clinical trial data plays in finding new indications and formulations. Yet at the same time, 38% of sponsor organisations described their ability to access archived clinical data and records as ‘extremely or very inadequate’. This percentage rose to 65% amongst QA, compliance, legal and regulatory professionals. (These practical issues echo the technical challenges that respondents faced with the interoperability of eClinical applications in the live trial: 39% of all respondents and 50% of CRO respondents found themselves unable to convert documents from multiple eClinical applications.)

In fact, the survey suggests that only just under a third of life sciences organisations currently run a digital archive of sufficient sophistication to ensure that data can be managed in accordance with the FAIR data principles. These were established to further scientific study through keeping data Findable, Accessible, Interoperable and Re-usable – all key attributes when it comes to making the most of clinical trial data, both as a driver of scientific discovery and as a substantial company asset.

As we learn to live, for the meantime at least, with COVID-19, the imperatives for digital transformation seem more powerful than ever. To quote Sanjeev Khagram of the Thunderbird School of Global Management, writing for the Economist Economic Intelligence Unit in April 2020: ‘The profound pressures that individuals, organisations and societies face in this crisis are accelerating the fourth Industrial Revolution (4IR) … The pandemic is forcing all of us to appreciate how much we rely on 21st-century technologies – artificial intelligence, the internet of things, social media, digital learning platforms, augmented and virtual reality, drones, 3D printing and so much more – to keep us healthy and to transform economies.’

Yet, in certain respects, it appears that the pharmaceutical industry is still to reap the full benefits of digital possibilities that have been available to it for some time. Pharma now has an opportunity to start giving renewed and longer-term life to its precious stores of data by means of what is known as digital preservation.

This is partly a matter of adopting the policies, processes, techniques and tools that are used successfully in other spheres by memory institutions such as libraries, museums and commercial and academic archives. These days, when we talk about data – not least highly regulated data such as trial master files – we should consider the full range of content and formats that can be safely preserved in digital archives: documents, emails, images, audio files and more. This is not just data in the classic sense, it is digital content.

Technology moves fast, and, in the normal course of business, data and digital content is likely to outlive the specific systems and environments that are used to store and provide access to it. Bearing this in mind, we need to consider sustainable governance and organisational frameworks, robust infrastructure, and comprehensive policies for the long-term management and preservation of crucial digital assets. If we are to ensure that they do indeed remain FAIR, we have to accustom ourselves to some further concepts expressed through acronyms. As we look to create trustworthy digital repositories, or TDRs, we simultaneously commit to upholding the TRUST principles that should guide the stewardship of any research data: Transparency, Responsibility, User Focus, Sustainability and Technology. As the pharmaceutical industry and the whole world of medicine knows, when it comes to achieving the most positive outcomes for patients, you need trust on your side.

Chris Sigley is chief executive of Arkivum