AbbVie’s Christopher Boone on RWE’s potential — and its ‘profound ethical dilemmas’

MEEFRO May 10, 2023

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Posting under the Twitter handle @DataHippie since 2014, Christopher Boone has established himself as a leader in using data to improve healthcare delivery. Today, his mission is to reimagine how biopharmas can use real-word evidence (RWE) to better enable clinical discovery, development and commercialization of drug therapies.

He is evangelizing his message internally at AbbVie as vice president, global head, health economics and outcomes research, and externally as an NYU adjunct assistant professor of health administration. On his YouTube channel, Boone also shares his views with the healthcare community about unlocking the potential of RWE.

One of his first orders of business upon arriving at AbbVie about three years ago was to establish a center for real-world evidence and a center of excellence around patient-centered outcomes research.

“These are capabilities that didn’t necessarily exist formally in the organization before my tenure,” he said. “We thought about the cutting-edge capabilities that were needed to usher in this new world and recruit the top talent and put them in one place and have them think about this world in a different way.”

“I think data is a public utility. How people analyze it, use AI models and all the other things they create around IP should be the competitive advantage.”

Christopher Boone

VP, global head, health economics and outcomes research, AbbVie

Boone is also taking a global view of what RWE means from a regulatory perspective, noting that more agencies are looking for data that can transfer from one trial location to another when making decisions around approvals. He said regulators are looking for data that not only reflects their specific patient population in terms of biological issues, environmental issues, etc., “they (also) want to know that they’re going to see the same positive response in their citizens and their patient populations who are living in the U.S., and that’s just the way it is.”

“There is a push from the regulators, payers and others to see more of this type of evidence being generated,” he said.

Here, Boone talks about the initiatives AbbVie is taking to move RWE forward, the challenges involved and what the future holds.

This interview has been edited for brevity and style.

PHARMAVOICE: In addition to the two centers of excellence you established, what other AbbVie initiatives did you implement to move the RWE needle forward?

CHRISTOPHER BOONE: We initiated our own health equity strategy from an outcomes research perspective. This is focused on things like clinical trial diversity, on access and outcomes and subpopulations that may not be seeing the clinical outcomes that other populations or subgroups are. We’re doing things around talent management. We want to recruit diverse researchers because they understand many of the culturally sensitive issues that can contribute to the overall health and well-being of individuals, which is important when you think about study design.

How does this translate into a new way of thinking about clinical trials?

(It revolves) around the clinical research enterprise, because I actually think it’s bigger than a trial.

This idea of n of 1 trials the continuous generation of data and evidence over the entire life span of an individual — to where we know what a patient is dealing with, what they are genetically predisposed to, what their environmental factors are that contribute to their health and how we develop these interventions. That’s what’s driving my thinking now — continuously generating the evidence that we care about. Certainly from AbbVie’s perspective, we care about people who have positive responses to our therapies. We are starting to segment or stratify those patient populations and understand what populations will benefit most and which ones will not. And then start to make that evidence available publicly.

What are the critical areas of RWE that need to be advanced to improve outcomes in the next five to 10 years?

We have to address the issues around some of the ethical constructs around privacy, fairness, accountability and so on. We’re at a stage now where we have to define this, I don’t know if it’s due to the pandemic and hearing more about clinical trials, but the public has a keen interest (in) how exactly we are using this data.

There is also the issue of human nature. People may not want to know they are predisposed to a certain disease. What can be done about that?

That’s one of the more profound ethical dilemmas that we face. People oversimplify this challenge by saying that the privacy issue is more about people having access to their data, when the reality is it’s more, to your point, that maybe people don’t want the data about themselves. I mean, it’s a case where ignorance is bliss. I want to live my life fully and not be concerned that I may potentially develop Parkinson’s at an early age. And this is fair. So, we should have the opportunity for people to opt into and opt out of these types of disclosures.

This almost needs to be part of the consenting process. There should also be an opportunity for people to say, ‘Yes, I will participate in this trial or this study, but I don’t really want to know (the results).’ It’s about giving people the opportunity to make the decision for themselves.

“We have to address the issues around some of the ethical constructs around privacy, fairness, accountability and so on. We’re at a stage now where we have to define this.”

Christopher Boone

VP, global head, health economics and outcomes research, AbbVie

I do think, though, genetic sequencing for all people needs to be done. Now, this is going to raise security and privacy concerns, I get that. But I say this because we will run into issues later, where, if we really want to move toward precision health, we can’t do that without the genetic data of an individual. We live in a society now that’s much more attuned and educated to the possibilities. They don’t know all the possibilities, but they know enough now to be able to push back on things that they want or don’t want. Ethical constructs around privacy and several other issues are important.

There are also issues around data quality, which gets into interoperability challenges. I don’t like to over-index the interoperability issue, but I feel it becomes the topic du jour rather than moving to a real solution. The lack of system interoperability contributes to the level of fragmentation that we have in our health system. Better data connections would lessen the questions around the validity and credibility of the data that we’re using to generate RWE, which is an issue that comes up all the time now.

Another area we need to address is around the increasing use of digital technologies and wearables. We have to be able to put that data in. It doesn’t have to be in a centralized place, but it needs to be connected for decision making.

The third thing is around data sharing. Data has been used as a competitive advantage, and I don’t think it should be. Data is a public utility. How people analyze it, use AI models and all the other things they create around IP should be the competitive advantage. But the data asset itself should not be, because that should be used in the overall public.

What about decentralized clinical trials and RWE going forward? Is there a chance the industry will revert to pre-pandemic processes?

The reality is that many of these big life sciences companies have invested quite a bit in the infrastructure that they use to run trials, whether it be partnerships with CROs or partnerships with academic medical centers, even though RWE and the decentralized trial approach has proven to be a more economical and more sustainable approach. We recognize the current status quo is not sustainable, I don’t care what you invested, you can’t do this very long.

And now we have a new macro-environment with the Inflation Reduction Act, which creates a necessity to rethink current business and operating models around R&D. This creates an opportunity for decentralized trials.

Another bigger challenge though — which I’m sort of excited about — is the large consumer retailers (Walgreens/CVS) that are now in this decentralized trial space and able to conduct clinical trials. I don’t think they are being clear about what problem they’re solving.

There is this virtual trial idea concept. There is still an argument to be made that there is a contingency of patients who like to be in front of their doctor. Some would even argue logistically, if you need to get an MRI or a CT scan, do these retailers have that capability or do patients still have to drive two hours to get those things? And if so, then what gives? (The answer might) be partnering with a local community hospital. We haven’t really penetrated that space. At the end of the day, it’s really around the patient experience.