The Dos and Don'ts Of Patient Centricity

By Life Science Connect Editorial Staff

Patient centricity is a multifaceted objective that begins with clinical trial design. Study participants should reflect the targeted patient population, and establishing trust with that community starts at the clinical trial level. Biotech and pharmaceutical companies must ensure that their trial design fits into participants’ lives.

Finding ways to make participants’ lives easier is more nuanced than jumping on the latest technology bandwagon. At a recent Clinical Leader Live event, Elevar Therapeutics’ Jennifer Lee, RSM US’s Steve Kemler, and Janssen Clinical Innovation’s Bert Hartog shared their best practices and cautionary tales for designing patient-centric trials in Hard-Earned Lessons From Clinical Trial Implementations.

Are DCTs Always The Answer?

Decentralized Clinical Trials (DCTs) can enable diverse populations to participate in clinical research, which increases the applicability of study results. Also, in the U.S., minorities are currently underrepresented in clinical trials compared to the general population. Since the pandemic, the FDA has increasingly prioritized diversity in clinical trial research, and this trend is expected to grow. However, DCTs are not the best fit for every clinical trial.

On the positive side, DCTs provide greater convenience for participants. According to a 2021 Forbes Technology Council survey, over 70% of the U.S. population lives more than two hours away from their closest research site.¹ It’s not feasible for many participants to spend hours commuting to research sites, creating recruitment delays that cost the industry millions each year. By providing patients with greater flexibility, DCTs reduce site visits and provide other conveniences such as real-time consent data tracking.

However, DCTs carry some disadvantages. First, they are more expensive than site-specific trials because they require more technological platforms and vendor partners. Companies have to balance increasing enrollment with the cost of conducting DCTs. Secondly, DCTs aren't the right fit for every study. For example, complex protocol procedures should be conducted on-site.

Also, DCTs frequently rely on participants to self-report data within specific time windows, such as submitting an ePRO while experiencing symptoms. However, participants managing serious diseases may have higher priorities than filling out forms. Technology becomes a burden to patients when they are asked to juggle multiple platforms and logins. Sponsors and pharmaceutical companies need to consider whether DCTs are making participants' lives easier or more stressful.

Wearable Devices: A Cautionary Tale

New, exciting technology can improve patient-centricity, but only when participant preferences are kept in mind. One of our panelists shared a story demonstrating the importance of participant buy-in.

A certain clinical trial decided to use smartwatches to collect patient data. Smartwatches are becoming popular for clinical research because they are readily available and widely used by the general population. The study recruited participants suffering from a chronic cardiovascular condition, and the smartwatch recorded how their daily activities affected their symptoms. This solution appeared to be an ideal, non-invasive method to collect round-the-clock data.

The study involved participants from multiple countries, and yet a pattern emerged: they weren’t wearing the smartwatches consistently after the first day or two. There were no mechanical problems with the smartwatches, and the participants were between 12-18 years of age, so they were assumed to be comfortable with technology. The problem was that the smartwatch chosen for the study wasn’t “cool.” It looked like a medical device, not a trendy fashion accessory, and the participants were embarrassed to wear it on their wrists around their peers.

This cautionary tale serves as a reminder that just because a device meets all scientific and safety requirements for a clinical trial doesn't mean participants will use it. This study focused on the smartwatch's technical features and forgot to ask the participants whether they liked it and were willing to wear it. If study designers had talked to participants in advance, they could have chosen a solution that was less visible or more appealing to the young participants.

Lessons Learned

The relationship between patient-centricity and trial design is complex. Study designers need to consider the precise targeted patient population to determine what methodologies and solutions fit well into the participants' lives. If in doubt, sponsors and companies should start by talking to participants themselves. After all, no one can convince a teenager to wear an unattractive medical accessory in public, no matter how technologically superior it may be.