Highlights from the TMF Summit 2023
Now that the dust has settled on this year’s TMF Summit in West Palm Beach, I wanted to take a moment to share some of my top highlights and learnings from the event last month.
For those of you who don’t know, the TMF Summit is a yearly conference run by Fierce Pharma that brings together some of the leading professionals in the world of TMF, for 3 days of workshops, presentations, and discussion.
So, without further ado, let me jump into my highlights…
What to do with data at the end of the trial?
While there is still a way to go, I’m starting to see a shift in mindset towards archiving digital records at the end of the trial. There were plenty of positive conversations had at the event about how best to approach the challenge of ensuring the long-term access and use of these records for the years ahead.
A big part of this is the concept of data portability; ultimately given how long these records need to be retained for, it is simply not an option to leave them where they are after the trials concludes for that entire period.
Organizations need to get comfortable with the fact that their data must be kept in such a way that it can be migrated in future…and that is going to be easiest at the conclusion of the trial rather than 3, 5 or 10 years in the future.
FDA regulations, guidance and best practice
Attendees at the conference were lucky enough during the keynote to hear from FDA Investigator, Craig Garmendia. While the views he shared were his own (and not an official statement or stance from the FDA), it was fascinating to hear his insights on the inspection process.
While I won’t share everything he said, there are two particular insights I want to flag. The first was his response to the question “What records do we need to keep?”.
His response illustrated the divide between what a sponsor must provide and what they can provide. Craig would like to see it all (even though the regulations don’t require it), it provides the clearest picture of the trial and how it was run, and any gaps in this could cause red flags for further investigation.
In a similar vein, he stressed not only the importance of maintaining good audit trails, but also conducting periodic reviews of those trails. Again, FDA regulations and guidance don’t state that reviews are necessary, but they do consider it best practice.
I think these two points really illustrate how regulations are very much the bare minimum of what sponsors are required to do; but to ensure smooth inspections with minimal negative findings, sponsors should be looking to good and best practice approaches and not just the regulations.
The big resignation
I heard it said in many sessions about the impact of the big resignation on managing clinical trial data and records. While industry employment trends will often fluctuate, it is fair to say that employees are switching jobs more frequently than ever before.
This really focuses attention on the importance of good record keeping, not only ensuring that records are well kept and ordered, but that the process for ordering them is also recorded.
This applies not only to live managed records but archived data. It’s becoming increasingly likely given the timescales involved, that when those historical records are required in future, it will be someone different who is trying to find and access them.
Digital Data Flow
The final point I wanted to highlight was the increased number of references to the ‘Digital Data Flow’ within clinical trials.
An initiative led by TransCelerate in collaboration with CDSIC and Accenture it is aiming to:
“…develop a Study Definition Reference Architecture that will serve as a standard model for the development of a Study Definitions Repository. The Repository is a novel central component aimed at facilitating the exchange of structured study definitions across clinical systems using technical and data standards.”
I won’t comment on it too much here, but the idea of unifying the language and standards used by the many clinical trial systems into a more seamless flow can have a huge impact on the sector. If it’s not something you’ve looked into before, I would highly recommend having a further read at the link above.
To wrap up I’ve covered only a tiny portion of what was discussed at the event, but I hope I’ve given a flavour of some of the topics that I found of particular interest.
If you have any questions or comments about anything I covered, please don’t hesitate to email me at Tom.Lynam@Arkivum.com.
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