How does AbbVie differentiate its approach to inclusive research in clinical trials?
We're not only looking at it on a trial-by-trial basis but are also focusing on addressing the legacy processes that created unintentional barriers.
In doing an internal audit of our systems and processes, we have implemented an enterprise approach to inclusive decision-making, from planning and the execution of a clinical research program to closing out and setting forth the program.
What is an example of that upstream, change management approach to diversity and inclusion?
One example is from when we examined the patient funnel. Real-world data tells us how many patients are diagnosed with a particular disease. As patients go through eligibility criteria, the screening process, enrolling, etc, of a clinical trial we start to see attrition. The problem is that those numbers don’t give the qualitative aspects of those patients. We’re not seeing who we’re starting to lose.
That’s where our commitment to inclusivity comes in; the team is focused on pulling together more of a qualitative and demographic understanding by age, sex, race and ethnicity for the patients we’re losing in each step of the process. That way, we can start to make informed decisions around how that criteria can be adjusted so that we can be more inclusive.
"We're not only looking at it on a trial-by-trial basis but are also focusing on addressing the legacy processes that created unintentional barriers."
What was the impetus for shifting the focus upstream, to ensure greater inclusivity and diversity?
We realized that we cannot simply look at diversity further downstream once the protocol is already set. Even if we want to get the awareness out there, and even if we have patients who want to sign up, if they’re not eligible then we’re not moving the needle.
So we looked at the areas of focus we needed to change, and realized that we had to move upstream. I always tell my team that this work is really about change management. When people think about clinical trial diversity or increasing representation, it’s always packaged as a heavy lift. But it’s not when you come with inclusivity top of mind from the very beginning, rather than something to react to after the decisions have already been made. If we can make the effort at the beginning to truly understand who we’ve typically recruited for and who’s living with the disease, beyond disease profiles, we can make targeted plans proactively to reach the patient populations that were previously untapped.
What is the path to ensure that trials are more representative of communities?
We start with framing the understanding that we have of the disease beyond just the disease profile. We identify the health inequities that exist, the subpopulations that have the highest disease burden and how that informs the planning. The biggest challenge is that the real-world datasets we have aren’t truly representative of all patients living with those diseases, for example the under-insured or the non-insured. That requires us to think specifically about how we capture their profiles because they interact with the care system differently.
When we look at a particular study, from the time we conceive a protocol to the actual closeout, we identify the considerations that we’re thinking about for those patients. When it gets to enrollment, we are laying on and leveraging real-world data for our sample size. We are benchmarking what “good” looks like for a representative trial.
"We looked at the areas of focus we needed to change, and realized that we had to move upstream"
What metrics or measurements are you using to ensure that trials are representative of communities?
From that sample size, we use real-world data to identify what we expect the breakdown to be by race, ethnicity, age, sex and gender identity. Once we have that information, we track enrollment in real time against the sample size. We're able to see not just the number of people that we're enrolling but who we're enrolling based on demographics.
It helps us to be better informed regarding the key tactics that resonate with those actual patients in real-time – as the information is coming in. We can dial up or down these activities based upon what’s working.
If you were not hitting the percentages you expected for certain demographics, what would be the course of action?
That’s the benefit of having a diversity plan in place and having our enrollment benchmarks upfront. We have mitigations put in place that are aligned with the enrollment goal planning so that we know what levers we will need to pull should the real-time tracking tell us that we're off-track.
Can you share an example of real-time mitigation?
We had a situation where we were doing well with recruitment for a typically underrepresented population. However, we started to see an uptick in premature discontinuations. We were able to isolate exactly when that was happening and in what study visit periods. Then we started to take a look at the profiles of those people discontinuing and went back to the sites to understand what the common themes were.
From that work, we recognized that the trial burden was very high at a specific point in the trial once you got past Month 1, specifically around the expectations of the questionnaires patients had to complete. To combat that, we offered more education around the questionnaire leading into Month 1 and we were able to start to see the premature discontinuation level off.
You’ve shared addressing barriers to participation in a Phase II uterine fibroids study. How did you identify those hurdles and address them?
We had put together a proactive plan, recognizing that uterine fibroids disproportionately affect Black American women and Hispanic women, who were historically underrepresented in research. Knowing that, we brainstormed ahead of the trial to understand all the challenges that might exist and how we could reduce that trial burden. We recognized that many of them were the ‘sandwich-generation,’ caring for elderly parents as well as their children. With that information, we asked what things we needed to consider, such as greater flexibility with scheduling.
In addition to the clinical trial awareness campaigns, we also wanted to engage in a way that made these patients feel supported. We created toolkits to support sites with open houses. We knew that there was apprehension from these women surrounding the medical system; the open houses provided a chance to see that there were other women who looked like them with the same diseases. Our PIs and their staff were able to talk about the study opportunity and provide education about the disease.
What was the response from sites and patients?
The open houses were well-received by the sites because it reduced the burden for them. There isn’t enough time in the day to have these one-on-one conversations. And from a patient perspective, they were able to see other women considering the trial, able to ask questions and build a community within the clinical trial.
We also put together episodic videos, providing an overview of the opportunity at each stage. It set expectations and helped patients visualize what a study visit would look like. We also did exit interviews and used those insights to help us plan for our Phase III study.
What else are you doing to make clinical research more diverse?
We can't have diverse representation without diversifying the site staff that's conducting our trials. We have created a new investigator pathway for physicians not exposed to clinical research but who would like to start the process. It’s important to say that this is a pathway because training is not enough. It’s about how we then provide the support that they need as they continue to build their clinical trial experience.
We give them the training at no cost. It’s no strings attached. It doesn’t mean that they have to commit to doing an AbbVie trial. It provides these physicians the foundational information on the differences between treating a patient in the standard of care and what it takes to conduct a clinical trial. If they show an aptitude for clinical trials, we could match them with an appropriate study based on their experience, mentor them and provide them with support that is right-sized based on their experience that will scale as they develop.
Do you have any other partnership initiatives to share?
A portion of our team is focused on clinical trial partnerships, where we take a look at the relationships we currently have, specifically with non-traditional partners. These are community groups that may not be advocacy groups, but whom we know are engaging the patients that we're looking for. We've been engaging with community groups that have a health component, with the goal of integrating the topic of clinical trials when the group is discussing hypertension, for example, or cancer.
We’ve been exploring and engaging a number of different partnerships, specifically within oncology where the highest health inequities exist. That's where we've been focusing right now, and we are looking to scale that across our other therapeutic areas as a model of what community partnerships could look like.
