Top 10 Ways to Transform the Patient Experience in Clinical Trials
Clinical trial recruitment has been a persistent problem, with studies showing up to 55% of trials are canceled prematurely due to low enrollment rates. These rates are even more dismal when it comes to diverse populations, including ethnic and racial minorities as well as seniors. Common methods for improving trial access such as transportation supports have been well documented, yet there are numerous other avenues for improving the patient experience that have yet to be uncovered.
We recently sat down with several patients, caregivers, and patient advocates, who shared their top 10 ways that trial sponsors can make trial enrollment and participation better for patients and their families.
1. Challenge your own assumptions.
Beliefs persist that some groups such as Black patients or seniors aren’t open to participating in research studies, leading many doctors to fail to offer these patients trial opportunities. Investigators should reconsider these assumptions, and let all patients know about trial options.
“My Mom’s oncologist dismissed the idea of an out-of-state trial for her because he assumed she wouldn’t want to travel that far for care,” said one patient. “We would have gone to the moon if it meant a chance at life.”
2. Connect patients with one another.
The idea of participating in a trial can be daunting, but connecting a patient with someone else who’s been on this journey can make the process a lot less frightening. “If you’re able to talk to other people who are in a trial, you’ll feel more comfortable among your peers, and that could also help recruit more participants as well,” said patient advocate LaToya Bolds Johnson.
Megan Lilja has seen the value of these connections for her whole family. Her daughter has been in a clinical trial to treat the rare disease galactosemia for the past two years. During that time, the trial sponsor made it possible for several families traveling to the trial to meet and fly together. “Some of these kids, especially in the case of rare or orphan diseases, haven’t met anyone else with their disease before,” says Lilja.
“Making connections with other families who are going through the same thing has been life-changing.”
3. Help patients to navigate trial information.
Information overload is a real problem when it comes to clinical trials. Sites like clinicaltrials.gov – though well intentioned – are overwhelming for patients to navigate. Think about how you would feel if your loved one was facing a scary diagnosis and you needed to read through reams of complex trial descriptions trying to understand what’s the best option.
“It should not be so difficult for the general public to be able to find clinical trials,” says LaToya. “Clinical trial navigators can help people to understand trials at a more basic level in terms of what trials do, what the purpose of a particular trial is, and how it may help that patient.”
4. Remember the golden rule.
The unknown can be scary. This is such a crucial time to put yourself in your patient’s shoes and really empathize. “Treat patients the way you want to be treated,” says Ricki Fairley, CEO of the patient advocacy organization TOUCH – the Black Breast Cancer Alliance. “If you were explaining a trial to your mama or your auntie, would you recite scientific data and check off boxes on a form, or would you hold her hand and explain it in a way she understands?”
Building these relationships can ease anxiety for patients and caregivers. When Megan Lilja had concerns about blood draws for her daughter, the trial contact made sure there was a consistent team of nurses with pediatric experience to work with her. “My child knows her main nurse by name. She saw him a few weeks ago when we traveled to Michigan for treatment, and she was so excited to see him,” shared Lilja. “They’ve built that rapport and that bond.”
5. Consider the language you use.
One trial sponsor invited TOUCH to provide input on the language used on its trial website, and found the experience quite eye-opening. “The early version of the site talked more about how the study was going to help the future as opposed to how it would help a patient,” says Fairley. “The words were very science-focused, and they used language like ‘placebos’, but that’s not a word you want to use when talking to patients. Nuances like that are important. You have to be intentional about everything you say and how you approach people.”
To demystify the clinical research process, TOUCH worked with the trial sponsor to produce a video sharing the firsthand experience of a young mom with triple-negative breast cancer who had participated in a clinical trial. “The trial has been successful because of videos like these,” says Fairley. “That’s what’s convincing other women to do it and to be comfortable with it.”
Outcomes data from PlatformQ Health’s patient education programs further confirms the importance of the patient perspective, highlighting how elevating patients’ voices helps change perceptions about clinical trials.
6. Make consent forms easier to understand.
Typically, when a patient is asked about participating in a trial, they’re introduced to a clinical research nurse, who’ll present them with a huge consent form to sign. These consents are necessary from a legal and ethical perspective, but they need to be written and presented in a way that is understandable and accessible to all.
7. Rethink the amount of data you need.
Trial sponsors understandably want to collect test data throughout trials to validate the safety and efficacy of a treatment. Yet sometimes these tests can be onerous. Do you really need to subject a leukemia patient to multiple bone marrow biopsies or need a patient to drive into the center each week for blood work? Consider what information you actually require and balance this against the impact this has on patients.
8. Expand hospital at home programs.
Many hospitals have in-home services for select patients with chronic illnesses, yet it’s uncommon for these services to be offered to trial participants. Often trials have strict rules, requiring all testing to be performed at a major academic center where the trial is offered. Being more liberal in certain guidelines (for example, allowing patients to receive blood draws or similar tests at home or at satellite locations) would make trial participation more feasible for more patients.
9. Support working families.
Several patients shared challenges they experienced during trials with finding childcare while they came in for an appointment or dealing with lengthy visits while balancing work. One patient reported: “My medical team seemed surprised that I was still working, but I don’t have a choice. I have bills to pay.”
“People are living longer with cancer and other diseases, but there seems to still be an assumption that the only responsibility patients have is coming in for appointments,” another patient reported. “It would help a lot if trial sponsors supported working parents who’d like to participate in trials but need a little extra help like a child care stipend or the flexibility to get tests done at night or on the weekend when they’re done with work.”
10. Ask patients how things are going.
Study sponsors often ask trial participants to fill out surveys about all kinds of topics, such as their eating habits and their mental health. Though well-intentioned, these can feel very impersonal. Instead, consider having someone who’s focused on fostering relationships with patients and their families. Proactively offer resources such as appointments with a social worker and/or a nutritionist.
“Ask patients how you can support them in other ways,” says Fairley. “That should be part of the regular conversation. Patients who feel supported and listened to throughout the clinical trial journey are more likely to share these favorable experiences with friends, family, and colleagues.
As Megan Lilja sees it, her family is a partner along the journey with their trial sponsor, who has impressed her with their level of communication. “The drug company has been open with us from the beginning. Even early on before the trial was open, they were sharing [early-phase] research findings. I prayed day and night for the drug. Getting those small updates was so helpful.” Now as part of the trial, her family has access to a patient family coordinator who they can ask questions to, as well as a nurse they can reach 24/7 if issues arise.
Ultimately, patients and trial sponsors need one another in order for research to be a success. Patients and their families have valuable perspectives that can help trial sponsors to improve the patient experience and, in the long run, increase enrollment. The more open dialogue that occurs between these stakeholders, the more likely the trial process will be positive for all involved.
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