When people-driven insights are at the heart of clinical trials, more – and more diverse – patients will feel invited to participate.
Today’s standard clinical trial practices and methodologies are backfiring. They assess patients’ eligibility to participate purely on the basis of their medical profile. This is a narrow approach that has exacerbated challenges in clinical research: restrictive protocols, a systemic lack of diversity and representation, and limited options for where, when and how people can participate. All of these have calcified over time into roadblocks to effective recruitment and study conduct. The result? Increasingly costly delays and continuously missed study milestones.
It has to change. That’s why at Hū, we’re doing things differently.
We’re not discounting patients’ diseases and unmet needs. But we are looking at the entirety of their lives – patients as people from different cultures and backgrounds, with jobs and families, who have their own unique set of priorities, aspirations, challenges, physical and economic advantages and limitations, concerns, fears and needs.
Seeing patients through this purposefully hūman-centered lens, it’s easy to see why the standard model for patient recruitment and engagement isn’t working – if it ever really did. More importantly, at Hū, we believe it’s possible to fix it: by truly understanding who patients are and what they need as consumers of a clinical trial experience. After all, there might be many patients in real need out there, but if the vast majority of the recruitment pool is unable or unwilling to participate because they just don’t feel welcome and their behaviors, personal circumstances and expectations are ignored, the size of the pool is irrelevant.
So we offer a variety of interconnected solutions that allow us to collect, synthesize, analyze and, finally, operationalize patient experience data and the actionable insights that result from it by:
- Applying behavioral science to give us insight into what motivates people toward action and activation – information that leads to more inclusive and patient-centered study designs and recruitment strategies that will increase representative enrollment and create attractive studies as a care option.
- Using a proprietary clinical trial propensity model to help us predict with more certainty which patients are more likely to participate in a trial.
- Creating study- or disease-specific personas by aggregating complex data about people as patients and as individuals into what we call Hū Persona 360. Far richer and more human-centered than data on a screen can provide, these personas generate strategies to engage patients who are not only ready, willing and able to participate, but excited about and more committed to being a part of the trial.
We use these methodologies, along with detailed insights into global differentiators, to give us a three-dimensional view of patients and the impact their disease has on their lives – insights that can facilitate more relevant trial designs; inspire more engaging and informative communications with patients; inform better study placements (i.e., we want patients to be able to participate irrespective of where the sites are actually located); help create more compelling and resonant strategies to engage the patients we want to attract; and, finally, help sites supporting the trial become more sensitive and responsive to the cultural diversity of underrepresented groups. In other words, we want to hūmanize the clinical trial experience for all those who might, and eventually do, participate.
An insights-driven approach such as this has become all the more urgent. Those who design and run clinical trials are increasingly caught between the pressures from regulatory agencies on one end, which are starting to demand the patient voice be brought into the clinical trial development process in a more obvious and standardized way, and patients on the other end, who are demanding greater flexibility from the healthcare model, which when applied to clinical trials would give them more opportunities, options and leeway to participate.
Before the COVID-19 pandemic, clinical trials were already moving toward decentralization, a process that accelerated over the course of the past year. But just as the conventions of centralized clinical trials eliminated many participants who either couldn’t or wouldn’t do what was necessary to participate (e.g., travel several hours to the trial site), decentralized clinical trials can be restrictive or make assumptions about patients that may not be true. For example, trials may require that patients have a depth of technological know-how (not to mention devices) that many do not possess, nor have any interest in acquiring. Or trials may think it is okay to fully remove in-person visits, even though some patients still prefer them.
Clinical trials that swing too much in one direction or the other aren’t the future. The future lies in giving people flexibility to participate in ways that work for them, which can only come from understanding more about them.
Ultimately, our goal is to modernize clinical trials in order to open them to a wider, more activated and committed patient audience. Using data and insights in new and innovative ways, we will help hūmanize the clinical trial experience from the start, remembering that people may live with their medical conditions and diseases, but they are more than those conditions and diseases. People are the future.