After the havoc of COVID-19, ambitious strategies for digital transformation are seen as a wise investment as life sciences organisations upgrade their capacities for managing clinical trials and the valuable scientific and regulatory data they generate. This is the key overall finding of the second annual TMF Futures survey of over 300 life sciences professionals, conducted on behalf of digital archiving specialists Arkivum.
The challenges of running clinical trials
More than half (56%) of life sciences organisations report that COVID-19 has had a negative impact on their ability to deliver on the objectives of their clinical trials, though this compares favourably to the findings of Arkivum’s 2020 TMF Futures survey, where the figure was 69%.
Four in ten clinical trials were cancelled or postponed during the first wave of the pandemic (2020). Sponsors and CROs struggled to identify, recruit, and treat participants, and patients, often suffering from chronic and life-threatening conditions, were frequently unable to access trial treatments. 84% of rare disease patients in Europe – many of whom are enrolled in clinical trials – experienced a disruption of care, such as reduced access to diagnostic tests and therapies such as chemotherapies and infusions.
TMF Futures 2021: Good data in the age of digital transformation finds that, by Spring 2021, 41% of cancelled clinical trials were back on track. Each organisation is planning to conduct an average of 6.5 Phase I/II/III/IV studies this year, and every major clinical trial sponsor is now running at least one decentralised clinical trial. But it also finds that 90% of life sciences organisations are still facing challenges when running them – from recruiting patients and setting up protocols to managing data from multiple CROs.
Nearly half (49%) of life sciences organisations report that the pandemic has caused significant increases in the time of completing clinical trials, and 57% of life sciences organisations now say the cost has risen. $188 billion was spent on R&D in 2020.
‘Coming back stronger’ with digital innovation
Fortunately, digital innovations offer the prospect of tighter schedules and reduced costs for clinical trials – and also of reduced risk of failure, thanks to the potential of such technologies as artificial intelligence (AI).
In October 2020 the management consultancy McKinsey reported that, across industries, COVID-19 has accelerated the adoption of digital strategies by as much as seven years. In this context, life sciences companies clearly stand to benefit from further adoption of new technologies to accelerate scientific discovery and increase productivity and reduce inefficiencies. Indeed, looking to ‘come back stronger’ in the post-pandemic era, 80% of life science businesses are planning to invest significantly in digital transformation strategies to aid the conduct of trials and the management of data.
One-third of all TMF Futures 2021 respondents confirmed that, over the next 12 months, their organisation will make a priority of adopting new technology (such as cloud computing, machine learning, and AI) to aid the conduct of clinical trials and the management of trial data.
The primary focus for their investment in digital strategies will be on improving and accelerating the conduct of trials, for instance by decentralising clinical trials (47%) and by increasing racial diversity (34%) and geographic reach (26%) in the enrolment of trial patients. Another prominent aim is to improve identification of and communication with healthcare professionals and patient populations (50%).
Managing clinical trial data and archiving the eTMF
When it comes to the management of data produced by clinical trials, 38% of life sciences companies are looking to improve integration and archiving of large data sets, such as the crucial regulatory data held in the eTMF (electronic trial master file). The EMA requires the secure preservation of TMF data in an inspection-ready condition for 25 years.
Currently, just half (48%) of life science organisations say that, if they were inspected tomorrow by a regulator, they would be confident that their eTMF would pass an inspection and not incur a critical finding. (In 2014, the MHRA ruled that a deficiency in the eTMF could be classed as a critical finding in an inspection.) Even today, when the vast majority (90%) of life sciences companies maintain a digital archive, 1 in 10 say they would not be confident that they would pass a TMF inspection. Meanwhile, 30% of all respondents to the TMF Futures 2021 survey, and 80% of regulatory and compliance professionals, describe their TMF archive as very or extremely inadequate.
Most confirm that their data archives are not able to:
- Keep their data secure, accessible, and inspection-ready for 25 years (59%)
- Conduct searches in real-time to locate files in seconds (66%)
- Handle large volumes of data (75%)
- Upload data from multiple sources (81%)
- Provide a clear audit trail (83%)
Now more than ever, in an environment marked by transformation and acceleration, the eTMF holds significant potential beyond its fundamental regulatory role. Living data in the eTMF archive is also playing an increasingly important role in extending the applications of certain treatments. One in four (26%) life sciences organisations now access the eTMF archive to support an investigation or to provide regulatory oversight. Looking beyond these issues, many (66%) also access the archive either to: support the extension of the lifecycle of a drug (34%); to investigate repurposing of a drug (7%); for pharmacovigilance purposes (15%), or to meet broader commercial objectives, such as pricing and reimbursement (21%), legal challenges (21%), licensing (19%), and due diligence for mergers and acquisitions (12%).
‘This second annual TMF Futures report bears witness to a period of rapid transformation,’ says Arkivum’s CEO, Chris Sigley. ‘Over the course of the pandemic, digital technology – both established and innovative – has played a crucial role in overcoming physical interruptions and bottlenecks. Applied resourcefully, it has ensured the continuity of clinical trials and laid foundations for future ways of working. As we emerge from the Covid crisis, clinical trial teams can take stock of the challenges they have faced and surmounted since early 2020.
‘Just one of the many lessons learned is that technology, beyond enabling business continuity, can rapidly prove transformative. Over the past 20 years, data has consistently empowered discovery, driven business, and shaped our society. Over the coming years, it will play a central and multi-faceted role in reducing the cost of developing new therapies, bringing them to market more quickly and – through innovative thinking and practice – maximising commercial and societal benefits at every stage of the extended product lifecycle. In a transformed world, further empowered by digital technology, the life-sciences industry is in a position to come back stronger than ever before.
‘Whatever new challenges life sciences face over the coming years, Arkivum is ready to support the industry in making the most of its assets, expertise, and opportunities.’