Sector professionals believe COVID-19 must trigger a change in clinical trials

As a consequence of the coronavirus pandemic, 41% of global clinical trials in fields other than COVID-19 (c.4,5001) 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 just one of the findings of a major new report, TMF Futures: Keeping Data Alive, published by Arkivum in collaboration with Phlexglobal, the Ethical Medicines Industry Group (EMIG) and Survey Goo.

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.

More than 200 life science professionals were surveyed, all of them directly or indirectly involved with the management of clinical trial data and the trial master file (TMF). More than half (51%) say that there needs to be more diversification of patient enrolment for clinical trials – e.g. that trials cannot focus on just one city, country or even continent. 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 (39% of total respondents and 50% of CRO respondents are unable to convert documents from multiple eClinical applications);
  • the collection and archiving of clinical trial data (65% of compliance, legal and regulatory professionals describe their ability to access archived data as ‘extremely inadequate’ or ‘very inadequate’.

Unless addressed, these deficiencies could undermine any progress made in re-starting clinical trials; compromise the benefits of technologies being used to transform the TMF into an eTMF;  engender regulatory risk, potentially causing delays to marketing authorisations and hinder future access to TMF data, whether for pharmacovigilance purposes or in the cause of scientific discovery (new indications and formulations) and commercial growth (licensing, pricing and reimbursement, mergers and acquisitions).

All in all, these current deficiencies could stand to cost the life sciences industry billions.

Commenting on the report, 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.”


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