Almost three quarters of life sciences professionals believe COVID-19 will compromise their ability to conduct and analyse clinical trials in the next 12 month, data suggests.
As a consequence of the coronavirus pandemic, 41% of global clinical trials in fields other than COVID-19 have been delayed or put on permanent hold. Looking ahead, 74% of life science organisations say that COVID-19 will continue to compromise their ability to deliver on clinical trial objectives for the next six to 12 months.
That is among the findings of a new report, TMF Futures: Keeping Data Alive.
As the life sciences industry takes the conduct of clinical trials beyond the first wave of the crisis, 70% of survey respondents identify a crucial opportunity for changing the way clinical trials are conducted in the future – with technology as an empowering factor.
All the life science professionals surveyed were directly or indirectly involved with the management of clinical trial data and the trial master file (TMF) – the repository of information that supports clinical trial compliance and protocols.
More than half (51%) say that there needs to be more diversification of patient enrolment for clinical trials – for example, trials cannot focus on just one city, country or even continent.
Over a third (37%) say that more patients need to be enrolled to counteract possible future disruption, and 56% say there is a need for more virtual trials, incorporating telemedicine, remote monitoring of patients, wearable technologies, and mobile apps and devices.
While the life sciences industry continues to embrace new technologies enthusiastically, the survey findings point to major deficiencies in “interoperability between eClinical applications” – with 39% of respondents saying they are unable to convert documents from multiple eClinical applications.
The collection and archiving of clinical trial data is also a challenge, with 65% of compliance, legal and regulatory professionals describing their ability to access archived data as ‘extremely inadequate’ or ‘very inadequate’.
According to the report, unless addressed, these deficiencies could undermine any progress made in re-starting clinical trials.
They could also “engender regulatory risk, potentially causing delays to marketing authorisations” and “hinder future access to TMF data”.
All in all, these current deficiencies could stand to cost the life sciences industry billions, the report warns.
Over the last decade, the life science industry has moved to transform the conduct of clinical trials through the application of technology.
The quest to eliminate paper from clinical research – and thus increase efficiency, enhance collaboration and improve trial performance – has transformed the primarily paper trial master file (TMF) into an electronic trial master file (eTMF).
Over 90% of life science organisations have adopted eClinical applications, and 36% of sponsors and 48% of Contract Research Organisations (CRO) now use purpose-built eTMF applications to manage clinical documents.
Despite that, the survey finds that 45% of CROs continue to struggle to manage, locate and report data, while 50% are unable to convert documents from multiple software applications in order to make them usable.
When it comes to transferring valuable data from CRO to sponsor in clinical trials, many life science organisations use cumbersome and sometimes non-secure methods: 52% use email, 14% CDs, 12% data sticks and 25% paper files.
FDA and EMA directives require the data of completed trials to be maintained *n an archive – in a continuous state of inspection-readiness – for at least 25 years.
Over two-thirds (70%) of new sponsors use a digital archive. But the survey suggests that just 31% of life sciences organisations have a digital archive which facilitates good practice in long-term data management.
The survey also reveals that currently just 15% of organisations make plans for TMF archiving at the study start-up. Around a third (34%) do so at phase 1, in accordance with GCP (good clinical practice).
Meanwhile, 64% of life sciences organisations have experienced an inspection of an archived TMF, but the archive’s importance extends well beyond regulatory and compliance concerns.
As organisations make further use of technology and data to extend the lifecycle and commercial potential of approved medicines, the digital archive must be increasingly responsive
to broader objectives for innovation and commercial growth.
The report was published by Arkivum, in collaboration with clinical and regulatory software firm Phlexglobal, the Ethical Medicines Industry Group (EMIG) and Survey Goo.
Chris Sigley, CEO of Arkivum, said: “In so many aspects of our professional and personal lives, COVID-19 has highlighted the practical value and transformational power of digital
technology. Yet this report endorses a view expressed before the pandemic by influential voices: that in certain respects the life sciences industry has been outpaced by other highly regulated industries, such as banking and insurance, when it comes to digitisation. Now, as we all embark on shaping ‘the new normal’, is the time for the industry to overcome the digitisation challenges it still faces.
“In the case of clinical trials, successful digitisation presupposes efficiency and agility in collecting and managing data, and reliable interoperability between clinical applications. The electronic trial master file, or eTMF, has already become the norm, though our survey suggests that full interoperability often remains elusive.
“The crucial and valuable data in the TMF merits special treatment – and specialist technology – when it comes to being archived. This is not just in the interests of regulatory compliance, but also of future scientific discovery and commercial growth. Clinical data has a life far beyond the clinical trial.”