What is patient centricity in clinical trials?

“Patient centricity” means designing a treatment, clinical trial, or other health solution centered around the patient. Creating a patient-centric solution involves getting feedback from real patients and their loved ones, and making decisions based on their needs and perspectives.

The term can mean different things to different people, but to us, it’s about letting the patient voice drive how we think about the entire clinical trial process.

What does patient centricity mean for clinical trials?

Many clinical trials struggle with both enrollment and patient retention. Not only do 80% of trials struggle with enrollment, but some studies estimate that up to 30% of patients who join a clinical trial end up dropping out. Designing and running a study while keeping the patient perspective in mind can help at every stage of a clinical trial. There are several ways to put the patient first during each stage of a clinical trial, from enrollment to retention and study follow-up.

Patient centricity and clinical trial design

Clinical trial design is one of the most important places to involve the patient voice. Depending on timeline and budget, there are several options trial sponsors can explore to learn more about what would make a trial successful and accessible from a patient perspective.

Host a patient group. Patients can give the best insight on how disease symptoms impact their daily lives. Understanding the kinds of treatments that would make a meaningful difference can help greatly with both designing the trial and positioning it when you’re ready to enroll patients. The Clinical Trials Transformation Initiative has resources for those interested in working with a patient group through each step of a clinical trial.

Try a live protocol simulation. In 2017, AstraZeneca hosted what the company believes to be the first clinical trial simulation to measure patient sentiments. The company simulated a trial for lupus. Patients shared feedback, and many reported that the sessions were too long. In all, the simulation yielded 60 recommendations from patients on how to improve the experience.

Work with patient advocacy organizations. If you’re not able to host a patient group, working with patient advocacy groups and nonprofit organizations can also offer valuable insights into how patients will respond to both the goal and the logistics of your trial. Connecting with patient organizations can also help build trust from a community you’re engaging around your trial and clinical research participation. Partnering with these groups can open up dialogues around where needs are not being met in terms of current clinical trial conditions and treatment options.

Use real-world data. When designing your trial, look at patient data from previous trials or trial searches to understand protocol issues that may have slowed down or stalled past research, such as eligibility criteria that do not reflect real-world patients.

Patient centricity and clinical trial enrollment

When it’s time to enroll patients in your trial, try to think about participation from a patient’s perspective. If possible, work with a recruitment company that has experience getting feedback from patients themselves.

Keep health literacy in mind. Only 12% of Americans are “health literate,” according to a study conducted by the Department of Health and Human Services. When creating materials, consider researching the real language patients use to talk about their condition. Talk to patients about this, or even read through social media posts related to the condition. While a medical researcher or health care professional might use certain abbreviations or terminology, patients may not connect with that language in advertisements and outreach materials.

Communicate as much as you can in your ads and landing page. In our survey of 4,000 patients about their clinical trials decision-making process, patients reported that their key motivators include: access to a drug, therapy, treatment, or device that could extend life or improve quality of life, reimbursement for time and travel, and receipt of health care at a free or reduced cost. On your trial landing page, consider also including information like the number of study visits, whether or not overnight stays will be part of the trial, and whether travel costs will be reimbursed.

Patient centricity and clinical trial retention

Patient engagement is perhaps the most important when it comes to retaining trial participants.

Create a schedule with some flexibility, if you can. Keep in mind your patient population and what day-to-day life with their condition may be like. Some patients may need more time to get to appointments or prefer them to be earlier in the morning or later in the evening. If many patients are of working age, consider setting appointments for weekends instead of weekdays. 

Consider a decentralized trial model. In light of the COVID-19 pandemic, when it comes to actually running a clinical trial, researchers have been getting creative, trading traditional processes for virtual or decentralized opportunities. One major advantage of decentralized trials is that they minimize health risks for patients taking part, many of whom have conditions that make them especially vulnerable to COVID-19. This benefit removes the burden and any accompanying anxieties from patients and encourages participation from wherever they may be. Other benefits of decentralizing research include:

  • Improved patient experience: Participating in a traditional clinical trial can be difficult. Obstacles can include multiple visits to clinical trial sites over extended periods of time or visiting sites that are not always conveniently located. Technologies like telemedicine simulate the kind of face-to-face interactions that help build trust between patient and provider and lower the burden on the patients. Decentralized trials also improve the patient experience by making necessary in-person visits local and adding in digital measurement tools.
  • Lower barriers to recruitment: If a study is largely virtual, location becomes less of an issue, and clinical trial recruitment companies can cast a much wider net to speed up the process. 
  • Higher data quality: Technology like wearables helps researchers by providing real-time data. This is different from the typical trial experience, in which researchers get looks into very small windows of a patient’s life, chiefly when they’re at a site, or rely on self-reports in-between visits. Since data is collected in real-time, research staff can spend less time on data entry and more time on the science itself. The breadth of data that wearables provide to researchers allows for more accurate analysis and ultimately, stronger data.

Solidify your team of lab partners: Nobody should be excluded from your trial because they can’t make it to a central location for sample collection. Working with a direct-to-patient lab vendor — or their recruitment company partners — to safely provide participants with access to lab/diagnostic services can accelerate enrollment in your trial. 

Make it easy to get to your site. Arranging transportation for patients can make a big difference in retention. Increasingly, research sites are partnering with rideshare services such as Lyft and Uber to coordinate rides to site visits free of cost. Some sponsors offer to pay for participants' travel costs in the form of a stipend to participants to cover transportation costs such as reimbursement for gas, mileage, and mass transit fares. Certain trials may even pay for air travel.

Create a communication toolkit in layperson’s language. In your toolkit, include basic information about what a participant can expect from the trial, and set clear expectations for required time commitments. If applicable, include the patient’s care partner in the conversation as well.

If you’d like to speak with us about how you can make your clinical trial protocols and recruitment more patient-centric, get in touch with us today.