Chris Sigley explains why the devil's in the data when it comes to empowering innovation
Clinical data is, in every sense, a valuable asset. In the current year, the pharmaceutical sector is due to spend over US$200 billion on research and development (R&D), and clinical trials represent one of the most complex, costly and crucial disciplines in life sciences.
As the life sciences industry seeks to empower innovation throughout the R&D cycle – from drug discovery to regulatory reporting – new research has found that 73% of life sciences organisations are likely to make a substantial investment in technology to facilitate interrogation of clinical data on a large scale. Moreover, 68% of the 304 research respondents – all senior professionals in life sciences – reported that their organisations have accelerated their digital transformation strategies rather than simply persisting with them. To place this in a broader context, in May 2021, mid-pandemic, McKinsey reported that “across key areas of the business model, companies’ overall adoption of digital technologies had sped up by three to seven years in a span of months.”
The research, on the theme of ‘Transforming the Future of Clinical Data’, was conducted for Arkivum, a UK-based specialist in digital archiving and preservation, in collaboration with EMIG, the UK’s Ethical Medicines Industry Group. As the third annual survey of its kind, tracking views on digital transformation and the progress of clinical data strategies, it opens a longitudinal view on the ‘lockdown years’ (2020 and 2021) and 2022 as we re-emerge into a world transformed by the experience and learnings of the pandemic.
A long and productive life for data
Clinical data generated and collected today – as innovations such as AI, robotics, cognitive automation, real-world evidence (RWE), digital health and telemedicine set the pace – stands to have a long and diverse life. Regulation (EU) No 536/2014, which came into force in January this year, requires the data in the clinical trial master file to be archived and to remain readily available and accessible for at least 25 years after the end of the clinical trial in question.
Beyond regulatory requirements, the 2022 survey has highlighted a number of ways in which crucial data, records and files – if suitably preserved in a digital archive – play a role in meeting a wide range of scientific, regulatory and commercial objectives. These range from new formulations to patient safety, and from inspections to market access and mergers and acquisitions. For instance, 35% of survey respondents cited new submissions (i.e. support for new drug indications or drug repurposing) as a reason for accessing the archive.
During the pandemic, the TOGETHER trial, a 2021 collaboration between teams in Brazil, Canada and the USA, supplied a dramatic and auspicious example of the use of data in drug repurposing. Interrogation of historical data demonstrated that fluvoxamine – a low-cost treatment used as an anti-depressant – could be repurposed to prevent Covid-19 hospitalisations. In a very different area of medicine – the development of gene therapies – a prerequisite for unlocking scientific and commercial potential is access to vast volumes of rigorously controlled digitised data. This cutting-edge segment of life sciences is setting important precedents. Inevitably, its practice will become more widely applicable in the search for new treatment hypotheses, not least as AI facilitates interrogation and analysis of recent and historical big data. 36% of respondents to the Arkivum/EMIG survey stated that their organisations were running clinical studies on novel and next-generation treatments such as cell and gene therapies (versus just 23% in the 2021 survey), while 24% are exploring new therapeutics for diseases for which, as yet, there is no effective treatment.
Kinks in the lifeline?
The progress in digital transformation, like the possibilities it is opening up, is exciting. Yet, as in previous years, the 2022 survey suggests that life sciences’ best intentions could be undermined by inadequacies in data strategies and in the everyday collation, management and storage of data. Ambitious plans to improve the health of the planet could be hindered by seemingly run-of-the-mill issues such as missing files or siloed and inaccessible data, or by possible chinks in the integrity of clinical trial records.
According to the survey, 86% of all life sciences organisations face technical challenges when running a clinical trial. For instance, a third (34%) of respondents confessed that stewarding data is problematic, while more than half (53%) felt 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.” A substantial majority (84%) of respondents agreed that: “Storing and preserving clinical data, records and files enhances the value of data and its potential to drive innovation”. Yet 75% worried that their valuable data – gathered in a multiplicity of formats from a variety of sources and environments – was confined by departmental silos.
At the same time, it seems there are mistaken perceptions about the cost of storing valuable data, possibly in huge petabyte volumes, in a digital archive that is genuinely fit-for-purpose. These do not, in fact, have to be prohibitively high. In a false economy, a surprising number of organisations are still housing clinical data and files in storage solutions that prove inflexible, limiting access and impeding the ingestion and integration of data from multiple sources.
At the moment, almost a quarter (23%) of life sciences organisations are leaving their clinical trial data in their licensed clinical trial software system. On a purely operational level, the practice is not cost-effective, since storing the data becomes disproportionately expensive. On a strategic level, these systems – which are not designed as dedicated solutions for archiving and digital preservation – cannot ensure the long-term integrity, security, findability, searchability and accessibility of data. At the moment, seven in 10 specialists in clinical research view their organisation’s capacities for accessing archived clinical data, files and records as ‘extremely inadequate’ or ‘very inadequate’. The inference is therefore that organisations are exposing themselves to risk – and not just in the event of a regulatory data inspection. They could well find themselves losing access to data that is the fruit of major investment and which holds continuing scientific and commercial value.
Keeping the lifeline open
At a time when digitisation is transforming the life sciences industry, it becomes clear that dedicated measures to preserve clinical data are ever more worthy of detailed consideration. It is a matter of ensuring that, in the medium and longer term, valuable data remains FAIR (Findable, Accessible, Interoperable, and Re-usable), so that it can remain integral to discovery, innovation and commercial success. Still more than that, digital preservation is about keeping clinical data alive, so that scientific endeavour can continue to do its utmost to improve human health.
Chris Sigley is CEO of Arkivum
