Clinical researchers often site improved patient recruitment, engagement and inclusion as a goal in their work. A new clinical trial solutions firm aims to help hit those targets with technology designed to better bring in the patient thought process and include their voice.
Outsourcing-Pharma (OSP) spoke with April Lewis (AL), Hū’s executive vice president and general manager of clinical trial solutions. The conversation touched upon ways technology can elevate the patient experience and integrate the voice of patient participations from the outset.
OSP: Could you please share an overview of the clinical trial industry over the past several years? How have things like technology, protocol, patient-centric strategies and other factors changed?
AL: Over the past 20 years, the introduction of big data, platform technologies, and mineable EHR has driven significant improvements in evidence-based protocol design. Specifically, we have been able to streamline the validation of prevalence and incidence, confirm patient populations with specific Inclusion/Exclusion criteria, and automate the exchange of patient data through operational systems.
However, despite the introduction of buzz words like ‘patient centric, patient-first’, and the best of intentions, little has been done to re-design the patient engagement model from the current, highly tactical, Sponsor-CRO-Site-Patient waterfall model – leaving the industry at a standstill, and in some cases, decline in trial enrollment.
OSP: Could you please share how various aspects of human behavior impact trials?
AL: Misinformation, bias, fear, and perception of the pharma industry as a whole have significant impact on trial participation. Trial awareness is a major blocker in recruitment, with an immediate need for changing the perception of value that each patient brings to innovation, and the future proofing of tomorrow’s care options for their family and their community.
OSP: How have trials in the past taken decision making, values, motivations, fears and other aspects of human behavior into account—or have they?
AL: They have not. The strong majority of patient recruitment has focused on demographics, geo-targeting, and some consumer information as a means by which to create engagement strategies. There has not been a focus on decision making and quantifying behaviors associated with trial participation (until now).
OSP: How does factoring in human behavior benefit clinical studies—and similarly, what are the risks of failing to factor it in?
AL: By understanding the motivations and the biases of potential patients, we are able to have a more human conversation around the value of participation. This includes understanding the blockers of perception and creating engagement strategies that meet the patient where they are on their decisioning process – with the right message, tone, and embedded connection to the motivators for that individual's behavioral make up. The result is increased participation in trials, both in volume of participants and the speed at which trials are enrolled.
OSP: What’s broken about the current trial model?
AL: The current model is highly operational and highly tactical. Most studies take a ‘just in time’ recruitment effort, fueled with an assumption that just because we have the analytics to confirm the patients exist, that they will naturally want to participate. There is little coordinated focus on driving awareness, education and accessibility to clinical trials.
Today’s model defers to the physician to recruit the patient, there is no effort placed to engage patients more holistically prior to the trial, and no effort placed for gratitude to patients after the trial. This is particularly damaging in communities of color.
OSP: How does Hū’s model build/improve upon the traditional model?
AL: First, we are focused on the long game. This means we are deploying community engagement strategies that focus on trust-building, cultural nuances, access barriers, ambassador programs, and active listening. These engagement strategies start before a trial is developed, and long after a trial is complete.
Second, we have quantified decision making behaviors in unprecedented ways, enabling our ability to engage with large sets of current and future patients at scale, with an understanding of what motivates a patient around participation, which patients are most likely to activate, and which patients are in need of additional foundational information before a trial opportunity would ever become of interest.
Third, we are looking at patients as people, and personalizing the tone, the message, the timing, and the channels for engagement to drive more meaningful and thoughtful communication around disease management, trial literacy, and individual value in the R&D innovation lifecycle.
OSP: Specifically, how does this evolved model approach inclusion, and how does that benefit trials?
AL: The issue of inclusion is deep rooted; lack of diversity and inclusion in trials didn’t happen overnight, and it won’t be solved overnight. No single entity or solution can effectively address the issues and obstacles associated with achieving health equity.
However, through the combination of ethnic insights, behavioral science, and our local and national champion model, we are beginning the hard work of breaking down the perceptions, the mistrust, and ultimately, increase participation of minority populations as we look to close the gap in representative trial participation.