5 ways to reduce patient burden in clinical trials
When creating a clinical trial protocol, it’s important for sponsors to consider how each requirement impacts the patients who are taking part. While participating in a clinical trial can be beneficial for many reasons, it can also place a burden on patients who choose to participate. Complications with scheduling, transportation, and instructions can all create friction for patients — and can ultimately lead to dropouts if they are not addressed.
When all of this is considered, it is no surprise that many clinical trials face difficulties related to enrollment and patient retention. Not only do 80% of trials struggle with enrollment, but some studies estimate that up to 30% of patients will end up dropping out of a clinical trial — including 18% of patients who randomize into a trial.
Because patients can leave a trial at any time, there may be a number of factors that influence a participant’s decision to exit — but when sponsors make a point to focus on patient centricity in their trial design, it’s possible to reduce the number of patients lost. Considering patients’ pain points in your protocol design and site staff training can reduce patient dropout rates, which can lead to a lower cost of patient recruitment.
Consider health literacy when creating clinical trial materials
For anyone outside of the medical field, medical jargon can be difficult to understand — especially when considering that the average American reads at a 7th-8th grade level. In fact, according to a study by the Department of Health and Human Services, only 12% of Americans are “health literate." Many individuals find it difficult to understand all the information presented in trial materials, such as dosage amounts, consent forms, acronyms, and other common forms of medical lingo. This lack of health literacy can result in poor health outcomes, higher hospitalization rates, less use of preventative services, and poorer health management.
When you create your patient-facing materials, it’s important to keep this in mind. Instructions that are easy to follow can make a big difference, as can training site staff to respond to common patient questions throughout the trial. If your trial requires patients to administer medication, providing simple dosage directions can also help patient adherence. To get an idea of the readability of your materials, consider soliciting feedback from patients or consult with a trusted partner to make sure your materials are not unnecessarily complex.
Think about how a clinical trial may impact a patient’s life
While site visits are sometimes necessary to a study’s design, for patients, they can also be a major barrier to participation. Juggling general life responsibilities on top of a medical condition can already be overwhelming, so adding site visits and travel requirements into that can complicate a patient’s life.
When designing your trial, consider what impact the condition being studied has on a patient. For example, arthritis patients may struggle to open certain types of medication packages, making it difficult for them to adhere to a study’s medication regimen. For patients in the invisible illness community, Antidote had the opportunity to learn about specific pain points from this community’s patient advocates and learned how fatigue and chronic pain can often be a hindrance to participating in certain trials.
Offering options that accommodate patients’ needs is vital to achieving adequate study participation. To better understand your patients, consider running a focus group or connecting with an advocacy organization to glean more insights into what living with the condition in question is actually like. Making use of virtual check-ins, offering more flexible scheduling, and reducing the number of site visits required can all help reduce barriers to participation.
Provide training for clinical trial site staff
Providing a positive patient experience is important at every stage of the enrollment process, from clinical trial matching to a patient’s site visit — and it can make a significant impact on patient recruitment and retention. Many patients who participate in a clinical trial are doing so for the first time, so thoroughly training staff to be able to answer questions and address concerns may make the difference between the patient deciding to participate or drop out.
All site staff should be able to clearly communicate trial expectations with patients in a friendly manner so participants have a full understanding of what taking part in the study will entail — this overview should include what medical procedures are involved, any medications that may be necessary, and how often site visits will take place. This can also be a useful conversation for patients, as they can bring up any concerns about transportation or visit scheduling, and ask any other common questions that site staff will need to address.
Offer fair compensation and incentives to trial participants
Though altruism is the primary reason people opt to participate in clinical trials, offering fair compensations and incentives to participants can have a positive impact on enrollment rates. This can include benefits such as paying travel costs, providing compensation for participants’ time, or offering virtual check-ins to reduce travel burdens on participants.
In a survey regarding barriers to clinical trial participation, respondents rated the inconvenience of travel as the number one reason for declining to participate. Research from Deloitte backs up this finding, as their data shows that 70% of potential clinical trial participants live over two hours from the nearest study center. Though offering compensation or travel services may add costs to your study, it can potentially help you save by reducing the overall cost of patient recruitment.
Use technology to improve the patient experience
Technologies such as text messaging services, email newsletters, and electronic patient-reported outcomes (ePRO) can be a great way to engage patients throughout a trial. Some research even suggests that patients who have the option to report symptoms and answer questions digitally are much more compliant than those who use paper forms. Allowing patients to record data via a smartphone can also allow them to provide responses in real-time, which can allow for more accurate reporting. If you do choose to use ePro or other technologies in your trial, be sure to train site staff so they can answer questions about the technology to reduce friction in the patient experience.
Creating content about the clinical trial experience can also build an informed audience for your study. Blog posts, educational guides, videos, and articles can be drafted with a relatively low investment and can be used to educate patients, highlight the importance of research participation, and provide helpful tips for managing a condition — all of which can engage patients and expand the reach of your platform in order to bolster recruitment efforts.
Antidote connects engaged patients with research opportunities. Download our case studies to learn how we aim to make every part of the recruitment process patient-focused.