Patient Retention Begins at Study Concept
I would like to share my thoughts on patient retention in clinical trials based on over 15 years of experience in clinical operations .
Implementing a well-thought out patient retention strategy is something that should not be overlooked and needs to be locked into the development plan from its conception. Adhering to this strategy will go a long way to keeping the trial within its planned timelines, reducing cost, lowering risk to the integrity of study data and speeding up product approval. There are three defined stages during which a sponsor can exploit a patient retention strategy. These are the study concept phase, the patient consent phase, and the patient participation phase.
Patient retention strategies
When designing an effective patient retention strategy, planning should begin at the earliest stages of the clinical development program. At this time, it is crucial to keep the patient’s motivation for participating in the clinical trial constantly in focus. When developing the protocol, sponsors should consider how the study design will translate into patient burden for study participants. Patient advocacy groups are an ideal partner when doing this. Through an advocacy group, patients can be sent a short questionnaire inquiring which factors are important motivators for them to participate and remain in a clinical trial. Additional questions related planned study procedures should be included. This patient focused methodology can define upfront for the sponsor key patient perceptions of study burden, potential questions patients will ask about the trial, areas of concern for the study participants and what motivates patients to participate. Collecting this information during protocol development can be used to modify aspects of the study design undesirable to patients and to educate investigators to be aware of patient needs and concerns specific to the study during conduct.
During the patient consent phase, the investigator and the team play an important role in educating and engaging the patient. Keeping in mind that giving of informed consent must be maintained throughout the trial, having an investigator respond promptly and personally to any questions related to the trial go a long way to making a patient feel that their concerns are taken seriously and their contribution to research is valued. This is especially important in placebo controlled trials. In this type of trial, the investigator needs to explain the role of the placebo in the context of the risks and benefits and potential side effects. The investigator meeting is the ideal setting for the investigators and sponsor to discuss how to best assuage patient concerns as they related to placebo controlled trials.
After patients begin to participate in the trial, the time for engagement begins. Two of the most common reasons given for patients withdrawing from a trial are that they do not feel appreciated or find continuation of participation burdensome. Sending reminders of upcoming visits and proactively communicating with patients through tools such as the online platform Be the Partner help to engage patients between visits by providing them with trial examination results during and even beyond the trial. Utilizing home research nursing services can reduce the burden on elderly or very ill patients who cannot easily travel to the investigational site. This may be worth incorporating into the trial design if it will be drawing heavily from this type of patient pool.
In conclusion, effectively dealing with the issue of early patient withdrawal requires using a toolbox that leverages current technology and engagement by the site or sponsor representative to optimize patient retention outcomes. A patient retention strategy should be built into the trial design from its conceptualization phase and continued into study conduct over the duration of the trial. With this approach, patient retention activities which occur on an ongoing basis allow the sponsor to maximize on multiple opportunities to maintain high retention and patient engagement throughout and beyond the trial.