Article is based on concepts provided in “Principals and Practice of Clinical Trial Medicine” by Richard Chin, Richard Yoonsik Chin, and Bruce Y. Lee
Recruitment and retention of patients on a clinical trial is unquestionably crucial to the success of the study. Since recruitment alone can be a long, tedious, and costly activity, it is critical that enrolled subjects maintain their participation for the duration of the trial. Dropouts lead to inferior data, low staff morale and increased trial costs. Therefore, it is imperative to examine the reasons behind subject dropouts and ways to overcome these hurdles.
Know what motivates the patient
In an effort to understand why subjects drop out, it is helpful to identify the motivating factors for participation. Often, individuals are looking to help advance medicine—either for themselves, or the affected community as a whole. Those with conditions for which they are seeking treatment stand the most to gain, and therefore, may have the highest expectations of the trial. If at any point the trial does not reach their hopes, the risk for dropout increases. The best way to meet expectations is to thoroughly communicate them prior to the subject starting in the trial. Throughout the life of the trial, there may be unexpected circumstances that cannot be controlled, such as relocation, personal issues, or financial constraints. That said, using empathy and understanding, most concerns can be addressed with clear and open communication.
Listen to the patient’s concerns
Once on the study, a patient may voice a number of concerns such as difficulty complying with the protocol specifications (number of visits, dosage schedules, etc.), rumors from media and Internet sources about the protocol or other treatments, or simply loss of motivation. Providing as much educational material as possible and discussing all expectations with the subject prior to starting the trial can reduce many of these concerns. One strategy is to remind subjects of the value and importance of their contributions with words of encouragement and positive feedback.
Always keep an ear open for warning signs that may indicate the patient is struggling with the trial. Use them as an opportunity to dig deeper to identify their real concerns. Simply listening to patients and being empathetic to their needs can greatly reduce thoughts of withdrawal among subjects. Providing a confidential outlet for subjects to provide feedback or complaints can be a valuable tool for patients who may not be comfortable vocalizing their concerns in person. Getting this honest feedback provides the opportunity to address any issues that may arise, perhaps even from something as simple as a misunderstanding.
Maintain open and individualized communication
Be mindful of the amount of communication between the patient and the study staff. It is often beneficial to limit the number of staff working directly with the patient to build a more personal connection and rapport. Additionally, ensure that the patient has the means to communicate with the designated staff at all times during the trial, whether by phone or email, should they have any questions or adverse events to report.
An atmosphere that encourages patients to feel comfortable, respected, and actively involved in their care goes a long way in the realm of patient retention. Remembering that subjects are volunteers, and as such, can opt-out of the trial at any point should motivate study staff to do all they can to make the entire process a positive experience. This starts with the first interaction, whether it be a screening call, study visit, or an advertisement.
Other retention tools to consider include patient newsletters, self-monitoring tools, and personally calling to follow-up and provide appointment reminders. To ensure patients can conveniently return for visits, make sure they feel their time is equally as valuable as that of study staff. To this point, keep the following factors in mind:
- Is ample parking available?
- Is the waiting room inviting?
- Are scheduled appointments kept timely?
- Are appointments scheduled according to the patient’s schedule as much as possible?
Ultimately, there will be some patients that withdraw from a study. There is no magical formula to guarantee that every subject enrolled will complete the trial. However, by listening to the patient, providing ample resources and a pleasant environment the occurrence of dropouts can be reduced.
To learn more about patient enrollment and retention statistics, view our infographic “Retention in Clinical Trials – Keeping Patients on Protocols.” Or, find best practices for building a successful strategy patient recruitment, download our free eBook, “Patient Recruitment in Clinical Trials: Steps to Develop a Successful Enrollment Strategy.“