Clinical Trial Contracting Challenges: Streamlining CTA Negotiations Beyond Legal Language

Kaitlin Kelleher:
Hi everyone. Welcome to this podcast from Cambridge Healthtech Institute for the Clinical Trial Forecasting, Budgeting, and Contracting meeting, part of SCOPE Summit, taking place February 12th through 15th, 2018, in Orlando, Florida. I'm Kaitlin Kelleher, Conference Producer. We have with us today one of our speakers, Debora Araujo, an associate director and the U.S. group head of site budgets and payments at Boehringer Ingelheim. Thanks for being here today, Debora.

Débora Araujo:
Absolutely. Thank you for having me.

Kaitlin Kelleher
So you're an associate director of site budgets and payments at Boehringer and previously served as associate director of clinical contract services. In addition, you have over a decade of experience within the clinical contracts, budgets, and payments area. Tell us a little bit about some of the daily challenges you have faced and what impact you think these have on clinical trials at large.

Débora Araujo:
Sure thing. I think, within this space of clinical contracts and budgets, payments, I think there's an overarching challenge that we have in our industry, which is to ... sort of the three-legged stool scenario where we're trying to manage costs, quality, and do it all in a really fast timeframe, right? I think it's no different within clinical contracts and budgets and in the payments arena. But in more detail of that area, the challenges that we go through and that I have faced in the past is within clinical contracts, we obviously have the language barrier in terms of the CTA language in the negotiations.

We have budget negotiation barriers, making sure we're within fair market value and still covering costs for sites. We obviously have also some challenges with CRO-managed negotiations and making sure we have the right CROs in place to do that. Within the space of contracts and budgets and payments, we also have a little bit of a lack of standardization in our industry, which I think many colleagues in this space will agree with. Along with the standardization, the lack thereof, there's also a little bit of a lack of innovation in terms of contracts, particularly in better ways we can do that. Those are some of the challenges.

I guess maybe the last challenge I'll say is what I call the peripherals, is everything else other than contracts, budgets, and payments that actually affect it. We have all these types of challenges that we face daily within this space and just the overall impact, I would say, within clinical trials overall at large. When we're having the impact, especially in the contract negotiations piece side, when we're having delays there, we're really impacting our study's start-up and having our site start and really having our patients be able to participate in the trials. Overall, at the very end, what we're looking at is a delay in having our patients get the treatment that they need, the life-saving treatment many times, in a quicker timeframe. I would say those are some of the major challenges that I've faced and I've seen and we continue to face, I think, as an industry within the realm of clinical contracts and budgets and payments as well.

Kaitlin Kelleher:
You're speaking at SCOPE Summit 2018 specifically around streamlining CTA negotiations beyond the legal language. What are some of the barriers within and beyond the legal language you've faced and how did you work them out?

Débora Araujo:
Within the legal language, I would say that's perhaps one of the biggest barriers that we have within CTA negotiations currently. I think one of the major barriers within the legal language, I'll say, is really being able to get a consensus between all the parties involved, particularly the sponsor and the site, be able to get a consensus on the must-haves and the nice-to-have sort of situations. So the areas that we really see a lot of challenges is the bigger areas of the CTA, which is publication, indemnification, intellectual property, subject injury, and confidentiality that say those the sort of the big ones that, within CTA, that we really see a lot of barriers.

It really stems from each organization, each sponsor and site, they have a certain level of risk they want to take within those areas. They have certain things they want covered. But at the end of the day, it's really being able to reach a nice compromise and a consensus in that. There's a lot of things that can be done actually within the legal language and being able to speed things up. Just one of them is just being able to have both parties sit and send their own organizations and look at what are their must-haves I mentioned, what are their nice-to-haves? What are areas they can be more flexible and allow for that flexibility within the negotiations really, and really assessing the level of risk they're willing to take and just being able to reassess that and reassess that constantly because the industry is always ... It's very fluid and it's changing, so it's being able to get that consensus.

Beyond the legal language, as I mentioned, there are a few things such as the budget, budget development, negotiations, CRO-managed negotiations. There's standardization, there's all these other things, regulatory and ethics approvals and committees, that are going on that are affecting CTA negotiations and really create a lot of barriers. There's many things that, practically, we can do, lots of strategies that we can do for addressing each of these. But I think, overall, the most important thing to remember in addressing the barriers beyond even the legal language is to make sure we're not addressing them in isolation. We're really needing to address them simultaneously and comprehensively. When we do that, we're really able to accelerate the process and the CTA negotiations and really speed things up overall.

Kaitlin Kelleher:
You've written a book on this topic as well, due out in February. Could you tell us a few highlights from the book?

Débora Araujo:
Sure thing. Absolutely. I have to preface by saying that making clinical trial agreements captivating, especially in a book, is a real challenge. Right? Except for the few people like me that actually enjoy the topic. But being in the industry over a decade, in this space, I started for places that I can go to and really be able to look at all these different barriers and things that are affecting and ways to address them. I couldn't find one, so it seemed like there was a big need in our industry to really be able to see all these different challenges and barriers that are affecting CTA negotiations and adding to the delays in one place.

So I decided to go ahead and write a book on it. Just to keep things a little more fun, I decided to put a little bit of a villain's comic storyline to keep everyone from falling asleep within this space. It'll be coming out in February, as you mentioned, and it's called The Four Villains of Clinical Trial Agreement Delays and How to Defeat Them. It'll provide really a more intimate look at each of these ... what I call in the book, the villains or the barriers to CTA negotiations that we talked about. It's gonna provide a little more of an intimate look at each of them.

But more importantly, it'll really show, and I hope that passes on to the readers and the people in the industry that are looking at it, it'll really show the readers how dealing with each of these what I call villains or each of these barriers simultaneously can really yield much greater results than if we are addressing them in isolation. I really hope that it'll be helpful to the folks in the industry so that we can really get this issue solved, not just for us but as we mentioned in the beginning, for our patients that really depend on getting these treatments out to them as quickly as possible.

Kaitlin Kelleher:
Well, that sounds like a great take on an interesting topic. Thank you for sharing some of those highlights, and thank you for your time today, Debora.

Débora Araujo:
Thank you so much. I look forward to speaking at SCOPE 2018.

Kaitlin Kelleher:
That was Debora Araujo from Boehringer Ingelheim. She'll be speaking at the Clinical Trial Forecasting, Budgeting, and Contracting meeting at SCOPE Summit on February 14th. If you'd like to hear her in person, go to scopesummit.com for registration information and enter the key code podcast. I'm Kaitlin Kelleher. Thank you for listening.