Preserving the Power of Clinical Data

For the life sciences industry, digital transformation is – unsurprisingly – a hot topic that keeps getting hotter. Large, complex datasets from diverse sources are ever more crucial to achieving a deeper understanding of diseases and to speeding the development of drugs and medical devices.

In the fight against COVID-19, the ground-breaking TOGETHER trial, a collaboration between teams in Brazil, Canada and the USA in 2021, provided a shining example. Through astute interrogation of historical data, it demonstrated that a low-cost repurposed medicine (fluvoxamine) could prevent hospitalizations. Meanwhile, the development of cutting-edge gene therapies, which relies on seamless access to rigorously controlled digitized data, has set precedents that can now be more widely applied in life sciences. Artificial intelligence (AI), facilitating effective analysis of recent and historical big data to create new treatment hypotheses, is opening up further possibilities.

Despite all this rapid and dramatic progress – and life sciences’ ambitious plans for the coming months and years – new research suggests that inadequate data strategies could be undermining ambitions for digital transformation. Such apparently banal issues as missing files or siloed and inaccessible data, compounded by potential compromises to the integrity of clinical trial records, could be obstructing endeavors to improve human health.

Tracking progress in digital transformation

Over the past three years, Arkivum, a UK-based specialist in digital archiving and preservation, has collaborated with EMIG (the UK’s Ethical Medicines Industry Group), to track the views of senior executives in life sciences on digital transformation and the progress of clinical data strategies.

In its 2022 survey, probing perceptions and practice in the wake of the pandemic, 68% of the 304 respondents reported that their organizations have accelerated their digital transformation strategies rather than simply persisting with them. Commercial objectives are inevitably a driver, with 52% stating their intention to prioritize improvements in productivity through streamlining processes, and 46% aiming to focus on reducing costs. That being said, scientific discovery is also very much on their minds.

36% say that their organization is running clinical studies on novel and next-generation treatments such as cell and gene therapies – an increase from 23% in 2021, while 24% are exploring new therapeutics for diseases that are not yet effectively treatable. A growing number of organizations are also conducting trials in repurposing and new indications of existing drugs (14%). Over the next 12 months, 85% of life sciences organizations say they plan to optimize the conduct of clinical trials, prioritizing the adoption of new trial designs and the use of real-world data (RWD), cited by 38%, while ensuring compliance with new clinical trial regulations (34%).

As the industry looks to innovate further over the entire R&D cycle – from drug discovery and clinical trials to regulatory reporting – three in four (73%) life sciences organizations say they are likely to invest substantially in technology to facilitate interrogation of clinical data on a large scale. This will be achieved through the use of such innovations as AI, robotics, cognitive automation, real-world evidence (RWE), digital health and telemedicine.

A further priority for 34% of respondents, with the pharmaceutical sector due to spend over USD 200 billion on research and development (R&D) in the current year, is to improve the management and conduct of clinical trials, one of the most complex, costly and crucial disciplines in life sciences. When it comes to the long-term archiving of the valuable data collected in clinical trials – which is subject to stringent regulatory requirements for integrity and accessibility over periods of 25 years and more – the techniques of digital preservation will come increasingly into play.

Data management: challenges and risks

The intentions are undoubtedly good, but the survey suggests that 86% of all life sciences organizations are experiencing technical challenges when running a clinical trial. For instance, 34% are struggling with the current realities of stewarding data – integration, management, reporting, and locating missing files. More than half (52%) of the survey respondents went so far as to say that: “Transferring clinical trial data from the clinical trial software compromises the integrity of the clinical trial data and files, thus causing breaches of regulatory compliance.” This will be a particular cause for concern following the introduction earlier this year of Regulation (EU) No 536/2014, which applies to the conduct of clinical trials.

A substantial majority, 84%, of respondents to the Arkivum/EMIG survey agree that: “Storing and preserving clinical data, records and files enhances the value of data and its potential to drive innovation”. Yet a hindrance for three-quarters of life sciences organizations is the fact that their valuable data – originating in a diversity of formats from disparate sources and environments – often sits in departmental silos. Moreover, the cost of storing data (sometimes running to petabytes) in a fit-for-purpose digital archive is often – mistakenly – perceived as too high. Clinical data and files are therefore housed in inflexible storage solutions that are frequently difficult to access, which means that data cannot be ingested and integrated from multiple sources. Currently, one in four (23%) life sciences organizations leave their clinical trial data in their licensed clinical trial software system. These systems are not designed as dedicated solutions for long-term archiving and digital preservation, so this practice could expose organizations to regulatory risk in the event of a data inspection – and to the broader risk of losing access to important and commercially valuable data. Nor, on a purely operational level, is the practice cost-effective. 

The preservation imperative

Whether a life sciences organization’s aim is to interrogate data on a large scale to recruit suitable patients for clinical trials, to gain data insights to support the repurposing of drugs, or to ensure robust regulatory reporting, its storage and preservation practices need to ensure that archived clinical data remains FAIR: Findable, Accessible, Interoperable, and Re-usable. Yet currently seven in ten specialists in clinical research would describe their organization’s ability to access clinical data, files and records as “extremely inadequate” or “very inadequate”. At a time when solutions are readily available, the position seems unnecessarily precarious.

As digitization further transforms the life sciences industry, it becomes clear that the preservation of clinical data needs to rise further up the corporate agenda. Preservation is not merely an end process, but an integral component of discovery, innovation and commercial strategy. Organizations across the board must recognize that historical clinical data is not something to be consigned to the past. On the contrary, it has an important part to play in ensuring in the future of life sciences, facilitating productivity, enhancing vigor and furthering progress.