5 Ways to Reduce the Patient Burden in Clinical Trials

When developing the protocol for a clinical trial, it's important to consider the potential benefit for patients taking part. At the same time, it's also crucial to consider the possible burden the trial may place on patients, too. Scheduling difficulties, transportation issues, and confusing directions can all create an unpleasant experience for patients that can ultimately lead to dropouts from your trial.

Unfortunately, 30% of patients across all trials drop out, including 18% of patients who randomize into a trial. Of course, patients are free to leave a trial at any time, and some reasons are very personal and unavoidable. But planning ahead to include the patient voice in your protocol design and site staff training can help reduce the patient burden and improve retention, while reducing the costs associated with clinical trial patient recruitment.

1. Think about the symptoms of the condition and how they may impact their day-to-day experience in the trial.

As you develop your trial protocol, consider what daily life is like for patients joining your trial. In addition to the symptoms your trial aims to treat, what other symptoms do patients tend to experience? Think about how these symptoms may impact patients. For example, an arthritis patient may have difficulty opening certain kinds of packaging for medication.

Earlier this year, Antidote spoke with patient advocates from the invisible illness community. For many with invisible illnesses, the fatigue and chronic pain that accompany these conditions can make it difficult to participate in research. Designing trials that account for flexible schedules can help.

For help understanding a specific patient experience, run a focus group, conduct a patient survey, or connect with a disease nonprofit. Use the information you gather to improve your protocol.

2. Consider health literacy when creating materials for patients.

The average American reads at a 5th-grade level, but the average medical information is provided at a 10th-grade reading level. Make sure all of your patient-facing materials are simple to follow, and that sites are trained to respond to questions from patients throughout the trial. Share materials with patients during a feedback session or consult with a trusted partner for feedback on readability. Simple-to-follow directions on medication can also help improve patient adherence during your trial.

3. Provide training for site staff.

In addition to a well-designed protocol, a patient's experience at the research site itself can also make a significant impact on patient retention.

The informed consent process can be key to ensuring patients fully understand what participation will entail. In a CISCRP survey, of patients who reported that it was difficult to understand the informed consent, 35% dropped out, compared with 16% of patients who did not find it difficult to understand.

To help, site staff should make it their goal to communicate trial expectations as clearly as possible, including what medical procedures will be used and how frequent site visits will be. During the conversation, site staff can also give patients the opportunity to express whether they will have any difficulties with transportation. Encourage site staff to share feedback from patients related to transportation challenges and other frequently asked questions that may impact patient retention.

4. Use technology to improve the patient experience.

Text messaging services, electronic patient-reported outcomes (ePRO), and other technologies can help engage patients throughout your trial. Studies suggest that patients who record symptoms and answer questions electronically, rather than through paper forms, are much more compliant. This method also allows patients to provide responses in real time as symptoms happen, with a timestamp automatically included.

If you do use ePRO for your trial, make sure that site staff are trained on frequently asked questions related to the technology and feel comfortable navigating the tools on a variety of devices, if patients will be providing their own.

5. Consider transportation options

In a survey conducted by the recruitment and retention company Continuum Clinical, 44% of research sites surveyed currently offer patient transportation assistance. This can include reimbursement for gas, taxi services, or ride sharing such as Lyft and Uber.

If you predict transportation will be an issue for your trial, consider working with a company that provides these services or offering compensation for patients who use them to get to your trial. Even if providing compensation or travel services adds up-front costs, it’s worth it if your efforts improve patient retention in your trial.

Antidote works with a network of 270+ partners to connect engage patients with research opportunities. Learn more about how we aim to make every part of the recruitment process patient centered in our case studies below.