Patient dropout: Why it happens and how to prevent it.

Patient compliance and retention are critical to the success of clinical trials. But they’re also two of the hardest variables to control, with the average dropout rate across all clinical trials totaling about 30 percent.1 And as you know, these patient dropouts result in costly delays and data errors that can compromise the results of a study.

While patients always have the right to withdraw from a trial at any time, many reasons for dropouts are preventable. Here you’ll find some of the most common reasons patients cite for leaving clinical trials – and what you can do to keep your participants around.

1. Inconveniences to the patient. An overwhelming number of visits and assessments, appointment times that conflict with work or school, long visits and wait times, and parking hassles are all common reasons patients give for leaving a clinical trial early.

What you can do: Starting with protocol design, try to minimize burdens on the patient. Reducing the number of visits and collecting only the information needed at each visit can help with this. Whenever possible, offer evening or weekend appointments so that trial participation doesn’t interfere with weekday commitments. Keep visits as short as possible, or lend a tablet, reading material, or games to help pass the time while patients are waiting. If parking is limited, provide valet service.

2. Forgotten appointments. A study is just one of the many commitments in a patient’s life. And while forgetting the occasional appointment is understandable, multiple missed visits can negatively impact study results.

What you can do: Traditional appointment reminder cards or stickers are an easy way to help patients remember where they have to be and when. Depending on the audience, text message reminders also work. If able, offer a study-branded mobile app. Apps can provide appointment reminders synced with the patient’s calendar, as well as a host of other helpful tools for study participants.

3. Unclear expectations. A patient may know a lot about his or her condition, but protocol language can be confusing to even the most informed study participant. If a patient is unsure about his or her role in a study, or feels confused about what to expect throughout the trial, he or she may become discouraged.

What you can do: Make patients aware of what will happen every step of the way, and make sure to remind them of upcoming milestones so they know what to expect. An educated patient is more likely to adhere to the protocol guidelines and understand study requirements. Set clear expectations up front while reviewing consent forms, but also be careful not to overwhelm them with information. Always communicate study objectives in easy-to-understand terms, and provide informational resources for patients to take home.

4. Lack of appreciation. If a patient feels like a number rather than an individual making a meaningful contribution to the study, he or she is much more likely to drop out.

What you can do: Show patients that you appreciate their dedication to the study by being available to answer any questions or requests. Make sure patients are content with the program and ask about their well-being. Remember that clinical trial participants are volunteers.Simple gestures, such as thank-you cards, make patients feel valued. Study-branded items are another great tool for improving patient engagement throughout the study. You can also choose to pay patients for their time and expenses, so long as the IRB ensures that the compensation amount is not coercive.

5. Condition stagnancy. Patients who experience positive results are less likely to drop out of a trial. But what about those who don’t? And what if symptoms or side effects actually become worse?

What you can do: Many people decide to enroll in a trial to help advance medicine – not just for themselves, but for everyone affected by their condition. Individuals who are placed in a placebo group or those who simply don’t experience relief of symptoms may become discouraged and decide to drop out. Site staff and investigators should listen to these patients with empathy and promptly respond to concerns. Negative side effects should be addressed immediately. Starting on day one, explain the importance of the patient’s continued participation in the trial as it relates to valid study results. Between visits, send newsletters with FAQs, important study updates, and messaging about the vital role participants are playing in scientific advancement. This will help to keep the patient engaged and dedicated to study completion.

In clinical trials, listening to and understanding your patient is important. But proactively acting on the information patients give is what keeps them engaged. If you have any additional questions about patient dropout and how to prevent it, get in touch with us.

1http://forteresearch.com/news/infographic-retention-in-clinical-trials-keeping-patients-on-protocols/

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