Technology Tools Alone Are Not Enough to Improve Compliance

Medication compliance is extremely important in clinical trials. Scientists estimate that the average medication compliance rate among trial patients is as low as 43 percent (1). With such low rates of compliance, it can be difficult to show the effectiveness of a medication. As a result, in order for sponsors to get their medications to market, they must find new ways to help patients be more compliant.

There are already a number of technological tools that patients can use to improve compliance in clinical trials. According to PEW research, 92% of U.S. adults have a cell phone and 68% own a smartphone (2). Most people carry their cell phone at all times, which makes cell phones a convenient way to remind patients to take their medications. Patients can use the alarms system built into their phone to set up an alert for when it is time to take their medication. Patients can also download a medication reminder app. These apps can then be programmed to sound an alert when it is time to take the medication.

Another tool clinical trials frequently use is an electronic daily diary to document when the patient takes the study medication. The patient may have access to the diary on their phone or may have to log onto a website to make their recordings. If the recordings are not made, the patient may be prompted by a phone call, text message, or email to remind them to take their medication.

Medical devices used in clinical trials can help improve compliance as well. In some studies, participants may need to use a blood glucose monitor or blood pressure monitor. Depending on when these devices are used, the machine may act as a reminder for patients to take their study medication. These machines may also provide automatic feedback to the clinical site when they are used, allowing the site to send an alert to the patient if the patient fails to use the machine at designated times.

Although these tools may be useful for improving compliance, they will not work if the patient does not know how to use them correctly or if there is a device malfunction. Devices can be prone to measurement errors, short battery life leading to missing data, improper use by patients unfamiliar with how to operate the devices, and purposeful misuse. (3, 4)

Ensuring that study personnel provide thorough education to patients is the crucial first step to guarantee that patients will use the available tools correctly. Incorporating a pharmacist into a clinical trial adds a knowledgeable health care professional who is able to provide both education and support to patients. A pharmacist can follow-up with patients once they leave the clinical site to confirm that patients know how to use the tools that have been provided to them, verify study medication understanding and compliance, and troubleshoot issues the patients may be having.

The pharmacist can also contact patients who are having trouble using the tools provided. Instead of sending an email or text reminder to the patient when they fail to record in an electronic diary or use a medical device, a pharmacist can call and determine the reason. Simply sending a reminder message does not help the patient if he or she is having a problem using the tool correctly. Rather, the pharmacist can help the patient work through the issue, get them back on track, possibly save them a trip to the site, and provide encouragement for continued participation in the trial. This interaction helps the patient gain confidence and feel empowered to comply with taking their medication and to meet study requirements.

Simply providing electronic tools to patients is not enough. Someone must educate the patients on how to use the tools correctly and be available to help the patients when they encounter problems. The more support the patient receives, the better the study outcome.