Digital Preservation & Archiving of Clinical Data
'Retaining data in a readable format as stipulated by EU regulation 536 may sound simple in theory, but in reality, provides numerous operational and technological challenges.'
Challenges to data retention and capability gaps within Life Sciences
As Life Sciences organisations continue to embrace digital transformation, there is growing pressure on the long-term management of that data. Balancing retention requirements between what must be kept, and what cannot be kept is tough.
This is in addition to operating in the context of evolving regulations which can provide limited information about what an organisation must actually do in order to be compliant.
Retaining data in a readable format as stipulated by EU regulation 536 may sound simple in theory, but in reality, provides numerous operational and technological challenges.
And yet, data preservation is not just about compliance with regulations – organisations who invest properly in the discipline can reap the benefit of having ready access to historic digital records. This data could be used for finding specific datasets for repurposing approved drugs or taking a broader view and used for strategic planning, trend analysis and decision making.
Do you agree there is value in retaining clinical data for future use?
Accessing clinical data archives
Generally speaking, and at least in principle, many Life Sciences organisations see the value in retaining clinical data for future use as seen in 84% of Life Sciences organisations agreeing (43% strongly) that “storing and preserving clinical data, records and files, enhances its value and its potential to drive innovation.”
Our study identified a broad range of reasons why organisations needed to access their historic trial data over the past 12 months.
The most common of these were:
- New submissions to support new indications or repurposing
- New formulations
- Repurposing
- Inspections
- Legal challenges
You can see the full breakdown here.
This highlights the importance of keeping digital assets in an archive which ensures they remain easily accessible and which preserves their integrity.
Data migration at the end of the trial
Over half of Life Sciences organisations (52%) believe that migrating data from the clinical trial software at the end of the trial would compromise the integrity of the data and files, thus causing breaches of regulatory compliance.
This view is reflected in the responses to a question on the destination of data at the end of the trial. Nearly one in four (23%) organisations leave their clinical trial data in their licensed clinical trial software system, with only 17% transferring to a dedicated digital archive.
The migration of data at the end of the trial need not risk the integrity of the data, or breach compliance guidelines. In fact, leaving the data stored outside of a fit-for-purpose archive is putting it at serious risk of loss, corruption and obsolescence – and often at a greater cost to the sponsor.
Clinical trial software does not have the appropriate capability to safeguard and preserve data for long periods such as up to 25 years, as stipulated by any drug, seeking to gain approval in the EU.
By working with data migration experts, trial sponsors can ensure any risk to the integrity of the data during transit is extremely minimal.
'...67% of people working in clinical research roles described their organisation’s ability to access data, records and files as ‘extremely inadequate’ or ‘very inadequate’...'
To what extent do you agree or disagree with the following statement?
“Transferring our clinical trial data from the clinical trial software would compromise the integrity of the clinical trial data and files, thus causing breaches of regulatory"
Current archiving and preservation capability
Following on from the above, the survey also highlighted the gap between the perceptions and realities of archiving and preservation capability.
When thinking about their strategy for archiving and digital preservation strategy, 67% of respondents working in clinical research roles described their organisation’s ability to access data, records and files as ‘extremely inadequate’ or ‘very inadequate’; by comparison, the figure for people working in commercial functions or holding senior management positions is just 25%.
Further research into why this gap exists is outside the scope of this report, but it would be interesting nonetheless to explore further.
Additionally, as few as 17% of life sciences organisations say they are not confident that their digital archive can guarantee the preservation of files in a format which will remain accessible for 25 years (i.e. protection from format obsolescence).
Only...
Maintain a clear & unambiguous audit trail
Only...
Provide data searches in real-time
Only...
Provide automatic integrity checks
These assertions do not tally with our experience of the industry or the responses to the survey question on the specifics of archive capabilities.
Less than a quarter (24%) of respondents’ archives could maintain a clear and unambiguous audit trail; less than half (45%) could offer data searches in real-time in order to locate files, and only 39% provided automatic integrity checks throughout the lifecycle of the data.
This suggests that further education about what is required to guarantee that retained data is accessible, readable and compliant for entire retention periods is needed within the sector.
You can access the full list of archive capabilities here.