Ignorance Isn’t Bliss: Don’t Assume You Know What Every Patient Needs in a Clinical Trial

When I arrived at a clinical trial simulation some time pre-pandemic (funny how those years blur together now), I parked my car, walked in the main entrance, and followed the signs down the hallways. My pace was even faster than normal as I was excited to find the conference room where I’d spend the day gathering feedback from patients and sites about an upcoming clinical trial. 

Like most meetings, it didn’t start on time, however, it wasn’t due to the usual reasons. We were waiting for the most important meeting participants – the patients! They had arrived at the building, but they hadn’t made their way to the conference room yet. Eventually, they sat down and the meeting began. As the patients shared their experiences and feedback, I remember being floored by my own ignorance and lack of consideration related to what they shared. 

The walk that took me three minutes from my car to the conference room had taken them 15 minutes or more. I was healthy and had no respiratory issues. They were not and required multiple rest breaks and oxygen. In our attempts to be patient-centric (by asking for their feedback), we had completely missed the opportunity to actually consider how we might best go about doing that. I was reminded of this story while attending the DPHARM conference in Boston last month when Jamie Macdonald, CEO of Parexel, implored the industry to evolve from being patient-centric to patient-led. 

Implementing a Patient-Led Philosophy

Being patient-led is more than just thinking about what, how, and when we need to do things for patients – it is about involving patients in every step of the journey by gathering their feedback, insights, and ideas and using them to optimize the patient experience. For example, asking them if they’d like to provide feedback at a meeting and if they had any concerns with the agenda, location, etc. (and perhaps finding out that walking through the building to the conference room was going to cause issues). There are three key areas where I see this philosophy (and execution on it) being extremely valuable. 

First, our diversity plans. It is not enough to simply attend conferences, debate internally, and roll out action committees. We must involve people from the actual communities we want to recruit from in our planning. And I don’t mean just asking them some questions on a survey – I mean meeting with them in-person, learning their experiences, concerns/hesitations, and what they would need to participate in a clinical trial. During a roundtable at DPHARM, one patient shared the two main reasons she hears why patients do not or cannot participate: one, health literacy (do they know or understand the trial) and two, feasibility (are they able to afford time off from work, how will they get to and from the visits, who will take care of their kids, etc.). While these are great starting points, the reality is that these may not be the only or most important reasons for every patient. And different patients will have different levels of health literacy and feasibility concerns as well! A patient-led approach to diversity would be including patients early on in study design and using their feedback to build trust, pick appropriate sites, and provide services or solutions to meet various health literacy and feasibility needs.

The second area where patient-led improvements could be made is protocol development. It isn’t enough to simply make certain visits virtual or provide wearables for easier data collection. Sponsors should ask patients for feedback on the entire protocol design. Hearing directly from patients related to I/E criteria (e.g., medications they cannot be on), concerns about being on placebo, invasive procedures, etc. will allow you to build a protocol that meets your key endpoints and provides the best possible experience for patients. 

Third, technology solutions designed for patients must include patient feedback in the design. We cannot simply make assumptions around what patients need. For example, I demonstrated the variability of individual preferences during my presentation at DPHARM by having audience members separate into groups based on their cell phone preferences such as type, brand, and carrier. In a room significantly more homogeneous than the populations we hope to recruit, there were easily eight different unique combinations of phone preference. Therefore, how many more variations exist in global diverse patient populations for things like travel, payment, and engagement preference? 

At Greenphire, we ask patients what they need and use that feedback to design solutions. Some patients need a reloadable debit card for their stipends/reimbursements. Others prefer direct deposit to their bank. Some will drive themselves to their visits, while others may need a Lyft. Technology solutions designed for patients must be done with a deep understanding of various scenarios around the world, ultimately delivering value for the diverse populations needed in our studies. 

As I was sitting down and catching up on emails at the end of the DPHARM conference, I looked up and saw someone walk by in a sweatshirt that partially inspired this blog. It read, “Have you asked a patient?” It got me thinking about the saying that “When you assume, you make a you-know-what out of ‘u’ and ‘me.’” When it comes to clinical trials, and our own unique involvement, I know I certainly don’t want to be a you-know-what, do you? 

If not, then ask a patient, because ignorance isn’t bliss.