What Is a Patient-Centric Approach in Clinical Trials
In 2020, accommodating patients with telehealth calls, at home-visits, or wearable devices became commonplace. But once COVID-19 vaccines arrived, research sites and sponsors were confronted with a question: should they continue running patient-centric hybrid or virtual trials, or switch back to traditional site-based trials?
Many of the research teams we work with have come to similar conclusions: think about what patients want. In other words, embrace a “patient-centric” approach to clinical trials. But what does it mean for clinical trials to be patient-centric, and how can clinical trial teams achieve this goal?
In this post, you’ll learn why a patient-centric approach works and how sites and sponsors can better accommodate patients without sacrificing efficiency or safety.
What does patient-centric mean?
Antidote, a patient recruitment company, defines patient-centric as “getting feedback from real patients and their loved ones, and making decisions based on their needs and perspectives.” Michael Keens of Firma Clinical Research adds that patient-centric trials are meant to “reduce the burden on patients.”
These definitions point out two important elements of being patient-centric. Clinical researchers must make trials more convenient for patients, and they must do so by asking patients what they need instead of guessing what they need.
Smartphones, computers, and WiFi have transformed how patients approach healthcare. Patients have more access to health information than ever before, and many of them want to be active partners in making decisions about their treatments. And by embracing patients’ feedback, research sites and sponsors may see benefits, too.
The benefits of patient-centric trials
Most clinical trial sites have trouble recruiting and retaining participants. 85% of clinical trials don’t meet their recruitment goals, and 80% are delayed by recruitment issues. The average drop-out rate for clinical trials hovers around 30%.
Because recruitment and retention can be so difficult, many clinical trial teams are actively working to make their trials more patient-centric. In a Huron study, 80% of research sites and sponsors said they were trying to improve participants’ experiences.
These sites and sponsors have the right idea. According to a different study in BioPharma Dive, trials that incorporated patient input took an average of four months to recruit 100 participants, while trials that didn’t ask for patient input took seven months to recruit the same number of people.
Patient-centric trial design may even help drugs be approved. The same study discovered that drugs developed with patient-centric trials had an 87% chance of being launched. Drugs that didn’t go through patient-centric trials only had a 68% chance of being launched.
Since patient-centric trials can decrease recruitment timelines and help therapies get approved, it makes sense that research sites, sponsors, and CROs want to become patient-centric. But how can they accomplish this goal?
How to make clinical trials more patient-centric
Investigators and sponsors need a plan to make their clinical trials patient-centric. Here are some tips that have helped other sponsors and sites understand what patients want:
1. Talk to patients about their needs.
Sponsors and CROs can begin building patient-centric trials by surveying patients about what would make clinical trials more convenient for them. Patients (or a caregiver, if the patient is a child) can let the sponsor know if they prefer site visits, remote check-ins, or stops at a local pharmacy or clinic.
Michelle Shogren, Senior Director of Innovation at Bayer, pointed out on our podcast that patients’ needs could even change based on where they are in their treatment. A patient who has just received a diagnosis has different needs than someone who’s been living with a disease for years. Sponsors may not be able to accommodate patients’ requests for every study, but they can listen and seriously consider those requests.
Some sponsors have also established official patient advisory boards. These groups are a great resource. But advisory boards shouldn’t solely review protocols you’ve already written. In a truly patient-centric trial, the advisory board will help you brainstorm protocols too.
2. Work with patient advocacy organizations.
While creating a patient advisory board is a great option, sponsors may not be able to create a board that includes a representative of every illness or patient demographic. Smaller sponsors and CROs may not have the resources to create a patient advisory board at all.
This is where meeting with patient advocacy organizations can help. These groups may be able to provide a broad perspective on what treatments patients are searching for and what trial requirements will be more convenient for them. Partnering with well-regarded organizations can also help sponsors gain participants’ trust.
Around 60% of sponsors and CROs now try to cultivate relationships with patient advocacy groups. While many sponsors, CROs, and sites meet with nonprofits in person, others rely on online forums to learn about patients’ perspectives on their illnesses and treatments.
Although forums aren’t a replacement for in-person meetings with advocacy groups, they can help researchers understand what it’s like to live with a specific condition.
Forums can also reveal which factors may cause patients to avoid or drop out of clinical trials. For example, if patients are sharing stories of how difficult it is for them to travel, sponsors and investigators know they should consider remote check-ins or sending nurses for home visits.
3. Design patient-centric protocols.
Once sponsors and investigators receive feedback from patient groups and nonprofits, they need to consider that feedback when designing their protocols. It’s easy to revert to old study designs instead of adjusting protocols to be more patient-centric.
Firma Clinical Research suggests examining every patient visit, test, or procedure to make sure it’s directly related to the clinical trial’s primary or secondary endpoints. If you’re requiring patients to participate in a visit or test that isn’t related to a specific endpoint, you may be able to remove it to make the trial easier for them.
You can also use real-life data to inform your protocols. Some sponsors have started looking back at recruitment timelines and retention rates from past trials. Recruitment difficulties may indicate that the eligibility criteria didn’t reflect real-life patients, while high drop-out rates may show that the protocols were too demanding.
One group of clinical trial researchers even ran a simulated trial to discover which protocols worked for patients and which didn’t. After the simulated trial, patients with lupus offered dozens of recommendations to make the real clinical trial more patient-centric for people like them.
4. Rethink recruitment.
Since 85% of studies struggle to hit their recruitment goals, it’s clear sponsors, CROs, and sites need to make recruitment more patient-centric. But how?
Sites and sponsors can look at the feedback from patient groups and advocacy organizations to understand how patients talk about their own illnesses and medical treatments. Clinical research teams can then use the same language patients use to make recruitment materials easier to understand.
When deciding whether to join a clinical trial, patients consider factors like whether the treatment could extend or improve their life, whether they’ll be reimbursed for travel costs, and whether they’ll receive additional tests at a free or reduced cost. Therefore, it’s a great idea to include information about reimbursement for travel or other healthcare costs in your recruitment materials.
You could even consider creating a webpage about the clinical trial that tells participants how the trial will work, how much of their time it will require, and which costs will be covered.
5. Accept patient feedback once the trial begins.
Don’t stop listening to patients after the trial has started. To improve retention, sponsors, CROs, and research sites need to know how patients are feeling throughout the clinical trial.
Rick Rohrbach, Managing Director of the Huron Consulting Group, suggests that researchers solicit participant feedback on clinical trial forms. For example, clinical research staff could ask patients whether the informed consent document made sense or how they feel about the trial so far.
Asking patients how they feel about the informed consent process is especially important, because participants often find informed consent documents long and confusing. In the Huron study, 42% of sites didn’t ask patients whether they understood the informed consent forms.
Research staff can make informed consent more patient-centric by using clear, simple language, providing translations where necessary, and perhaps even using videos. Many sponsors and sites are also looking into eConsent so patients can fill out informed consent documents at home or on their own device, with plenty of time to read and digest the information.
Try to make all patient feedback forms, from eConsent to surveys, easy to understand so patients can quickly share their thoughts with you.
6. Consider patients’ needs outside of the trial site.
Clinical trial staff sometimes fail to consider ways they can make patients’ lives easier outside of providing medical treatment. One study found that only 4% of research institutions offered to help patients communicate with their jobs about participating in a clinical trial. Just 31% of organizations offered accommodations for trial participants’ families, and no organizations offered childcare.
To run truly patient-centric trials, research organizations should consider reimbursing patients for expenses like childcare, their family’s overnight accommodations, and transportation.
Low-income patients may struggle to afford gas, public transit tickets, or rideshare services. Many parents with young children can’t participate in overnight trials unless their children have affordable care, and young patients may need their parents or siblings to stay nearby before they can participate in a trial.
Even if a clinical trial doesn’t require long-distance travel or an overnight stay, some patients may not be able to participate because of work. Scheduling appointments in the morning, the evening, or on weekends can make a difference for many patients.
Finally, consider whether patients can check in from home or from local clinics and pharmacies instead of from the research site. Remote technology has made it possible for many clinical trials to be conducted using a flexible, decentralized model.
How to turn patient-centric trials into a reality
Patient-centric clinical trials can help research organizations shorten their recruitment timelines and increase their participant retention. They can also improve the lives of patients.
But just deciding to be more patient-centric isn’t enough. Building patient-centric trials requires seeking out patient feedback, re-examining study protocols, and supporting patients outside of the study site.
To learn more about patient-centric trials, check out our post on how decentralized clinical trials will change research sites. You can also download our exclusive eBook on decentralized clinical trials.
The featured image on this post is from freepik.