The Importance of Clinical Trial Oversight when Outsourcing

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product manager, TMF practice area, Pharmalex, discussed challenges in the trial master file (TMF) space, highlighting outdated regulations such as ICH E6(R3).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: Cencora’s TMF Leadership Summit was just a few weeks ago. What were some key discussion points or trends that emerged from conversations there?

Jones: It was really good. Again, this is going back to my point about everyone being open and sharing, this was the nice thing. It was a group of us just being brutally honest about the struggles that we all face. There was one word that came up time and time again, and that word is oversight. It's something that has been in our industry for a long time. It's something that the regulation is now putting more pressure on, and it's also a word that I love, because, like many words in the English language, it has two meanings. One meaning is to oversee something, make sure it goes well, and the other is you miss something, and something bad happens. It produces this fantastic sentence that, again, in a lot of my talks, I like to bring it up on the screen, which is, “Without oversight, you risk an oversight.” It really says a lot that, again, in the past, oversight was just this idea of it's a tick-boxing exercise, but we're outsourcing more and more now. We're outsourcing to vendors, to partners, to just third-party groups in general. It's not always cost effective to do everything yourself in-house, and you don't always have the experience in-house, you can't have an A-team for everything you do. This idea of outsourcing is becoming bigger and bigger now the current regulations have really set that up as to what they expect, and in essence, what they're saying is just because you're not behind the wheel of the car at that moment doesn't mean that you should not be in control. You should be in control. You should be ready to correct when things go wrong. What we're having to do is really look at that support, really looking at making sure that it doesn't matter if it is, and this was part of what came up. It doesn't matter if it's a live trial that you're running today, and you're halfway through it, you've got loads of metrics, you still need oversight. It doesn't matter if you are getting to the end of the trial and you're about to receive it from a CRO partner. It doesn't matter if it's a trial that you never did, but your company has acquired that trial and that product, you need to prove oversight, and it's a real delicate balance, going too far one way, you're basically just doing the job that you outsourced, you're checking on everything, you're chasing people up, you're making sure that everything goes exactly as you think it should, and there was no point in outsourcing it, you've overstepped it. On the other side, what you don't want to do is just ignore it, and then when disaster does strike, if you're lucky, you know about it, but a lot of the time you don't even know that disaster struck you. You're oblivious to it, and unfortunately, regulators won't accept innocence. They will accuse you of ignorance at that point, so getting that balance and what we say a lot, is that idea of trust but verify, so when you're thinking about oversight, really think about what sort of checks you're doing. You don't want to do all of them, but how about a sample? You want to set your vendors up for success. You want to share ideas with them, and if you see something going wrong, don't wait for them to tell you, go to them, so have that two-way communication. There is no us in them, everybody's working towards the same goal, and yeah, that ultimately, over those two days that we had at our leadership summit, every talk, at some point, touched on oversight, and again, didn't matter what it was, oversight was still the thing that came in, and I think that's an area that again, as we move forward, as we think about what's happening and what's changing, it's going to become pivotal, especially when you're sat in front of that inspector and they say, “So, what did you do to make sure that this went well?”