Harnessing clinical trial data post-COVID

Booster COVID-19 vaccine clinical trial launches

A survey has found that post-COVID, ambitious digital transformation strategies are seen as a wise investment as life sciences organisations upgrade their capacities for managing clinical trials and the valuable resulting scientific and regulatory data.

The second annual TMF Futures surveyed over 300 life sciences professionals and was conducted on behalf of digital archiving specialists Arkivum.

It found that:

  • 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.
  • Four in 10 clinical trials were cancelled or postponed during the first wave of the pandemic in 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.

The report, TMF Futures 2021: Good data in the age of digital transformation found 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 the survey also showed that 90% of life sciences organisations are still facing challenges when running trials – 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 taken to complete clinical trials.

Digital innovations now offer the prospect of tighter schedules and reduced costs for clinical trials – and also of reduced risk of failure, thanks to the potential of technologies such as artificial intelligence (AI).

Life sciences companies stand to benefit from further adoption of new technologies to accelerate scientific discovery and increase productivity and reduce inefficiencies. 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%).

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 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.

Arkivum’s CEO, Chris Sigley, said: “Just one of the many lessons learned is that technology, beyond enabling business continuity, can rapidly prove transformative…In a transformed world, further empowered by digital technology, the life-sciences industry is in a position to come back stronger than ever before.”