Battling Outdated Regulations in the Trial Master File Space

In a recent video interview with Applied Clinical Trials, Rob Jones, product manager, TMF practice area, Pharmalex, discussed challenges in the trial master file (TMF) space, highlighting outdated regulations such as ICH E6(R3). When it comes to innovation and compliance in the space, he stressed the importance of a risk-based approach, focusing on critical records and leveraging artificial intelligence for big data analysis. Moving forward, Jones believes the TMF community's collaborative nature can be viewed as a strength in navigating regulatory changes and technological advancements.

ACT: What are some challenges the TMF space is currently facing? How do you think they can be addressed?

Jones: It's a nice, broad question. I think really the biggest challenge is keeping up. I think right now we've got new regulations coming in, things like ICH E6(R3) have finally come in this year, after being delayed for a little bit because of other things that were going on in the early 2020s. We've got new proposed standards from the reference model with V4 and all of this while trying to balance that desire for innovation, cost effective solutions, just an ever-changing landscape. I think one of the things that we have to look at and admit is regulations have been a little out of step for a while. We were expecting ICH E6(R3) months, if not years ago, but again, due to things that got delayed. That's fine, but a lot of things have already passed it by. The EMA has already put in new guidelines around their perception of the TMF. They had a brilliant new guideline around computerized system validation, which included things like the electronic TMF. The MHRA have been giving us more and more feedback on their current public forums and Q&As and things like that. It's kind of a little too late in some ways, ICH E6(R2) came out in 2016, and even then it was only a small look there in the grand scheme of things, realistically, it was written back in 1996. I don't need to tell you how much has changed since 1996. My marker for a lot of these things when I talk with people, is the first iPhone came out in 2007, so anything post-2007, you have had constant satellite communication world in your pocket. We're an industry that's built on stability, order, organization, we're managing clinical trial documents, but this new world hasn't been that for a long time, it's messy in a lot of ways.

The challenge really is, what do we do when the regulations are a little bit too old and outdated? How do we manage when other industries, especially outside of clinical trials, are just flying by, and what can we do to keep up without jeopardizing people's comfort, without jeopardizing all of the hard work that's gone into it? I think the nice thing really, with the TMF, and this shows every single time I go to a conference. It is one of the very few parts of clinical trials where it's an open book. There is a real community behind everything. Everyone's talking to each other. You go and talk with people, and they will tell you that TMF stands for “too much fun.” They'll tell you that TMF stands for “too many friends.” There is really this idea of everyone's in it together. I think the nice thing with that is that's been built from the beginning. The reference model when it came up was sponsors, CROs, vendors, consultants, all working together, sharing what they were doing. Nothing was secret. Nothing was hidden behind closed doors. I think, really, that is the biggest strength, and that's how we can address this ever-changing landscape, if we all come to get together and make a bit of a collective decision and say, “We as a group are going to make an interpretation of this, and this is how we're going to take it forwards.” There's a little bit where perception becomes reality, and if we're all pushing in that same direction, that really helps with how we can address all of this. I think, again, just for the TMF world, that's really how we're going to get by with these things changing at such a rate. It's one of the biggest strengths of our little, niche part of the industry.