Prescribing the Future of
Medication Adherence Solutions

Adherence to medication is crucial in clinical trials because it directly affects the integrity and validity of the study results. Clinical trials are designed to evaluate the safety and efficacy of new drugs, treatments, or interventions in a controlled and systematic manner. Therefore, study participants must take their medication as prescribed to ensure the trial results are accurate and reliable.

Poor medication adherence can lead to several issues in clinical trials. For example, it may result in incomplete or inconsistent data, which can compromise the study’s statistical power and reduce the ability to detect significant differences between the treatment groups. Additionally, non-adherence can lead to biased results, as patients who do not take their medication as prescribed may have different outcomes than those who do, even if they are in the same treatment group.

To minimize the impact of poor adherence, clinical trial protocols typically include measures to promote and monitor medication adherence, such as providing education and counseling. However, while education and counseling can certainly promote better adherence, in clinical trials with many participants, getting to the participants that require additional support can be challenging. That’s where AARDEX Group’s solutions come into play. Our medication adherence solution continuously monitors participant medication events to guide researchers to the participants that need support. Inherent stratification lists provide a ranked view of participants prioritized by the participants with problematic behaviors (missed days, drug holidays, overdoses, etc.)

By ensuring high levels of medication adherence, clinical trials can produce robust and accurate results, which are essential for making informed decisions about the safety and effectiveness of new treatments.

Adherence in clinical trials can be influenced by a variety of factors, including:

Patient-related factors: Patients’ health beliefs, attitudes, motivation, and perceived benefits and risks of the medication can affect their willingness to adhere to the medication regimen.

Patients’ understanding of the trial protocol, the medication’s purpose, and their social and cultural background can also play a role.

Treatment-related factors: The medication’s dosing frequency, route of administration, side effects, and regimen complexity can affect medication adherence. If patients experience side effects or find the medication regimen difficult to follow, they may be less likely to adhere to the prescribed regimen.

Study-related factors: The trial length, the study design, the blinding status, and the study setting can affect medication adherence. Patients enrolled in longer trials or trials with more frequent visits may be more likely to experience adherence issues due to the inconvenience and time commitment.

To address these factors, clinical trials may employ various strategies to promote medication adherence, such as patient education and counseling, simplified dosing regimens, side effect management, reminder systems, and supportive care. By identifying and addressing the factors that affect medication adherence in clinical trials, researchers can optimize the study design and improve the validity and reliability of the trial results.

Improving medication adherence in clinical trials can be challenging, but several strategies effectively promote adherence. Some factors that can improve medication adherence in clinical trials include:

Patient education and counseling: Providing patients with clear and concise information about the medication’s purpose, dosing instructions, and potential side effects can help increase their understanding and motivation to adhere to the regimen.

Simplified dosing regimens: Simplifying the medication regimen by reducing the dosing frequency, minimizing the number of pills or injections, and using combination products can help make the regimen easier to follow and reduce the likelihood of missed doses.

Reminder systems: Using reminder systems such as phone calls, text messages, or electronic reminders can help patients remember to take their medication and improve adherence.

Supportive care: Providing patients access to healthcare providers, social workers, or support groups can help them cope with the challenges of adhering to the medication regimen and provide additional resources and support.

Adequate monitoring and feedback: Regular monitoring of medication adherence and providing patients with feedback on their adherence can help improve their adherence to the medication regimen.

Patient-centered care: Considering patients’ preferences, cultural beliefs, and social circumstances can help tailor the medication regimen to their individual needs and improve adherence.

By employing these strategies, clinical trial investigators can improve medication adherence and increase the accuracy and reliability of the study results.

Several methods are used to measure medication adherence in clinical trials, each with strengths and weaknesses. Here are some common methods, sorted by accuracy. 

Electronic monitoring: This involves using either medication adherence packaging or devices that include hidden sensors or microprocessors that automatically capture and store the date and time the medication is removed/administered. The value of this type of approach is that it is non-invasive and does not add a burden for participants. Capturing this type of data is critical to understand how participants are taking their meds. And that is easy to understand because by using an electronic monitoring system combined with sophisticated remote monitoring software, like AARDEX Group’s adherence software, MEMS AS, sponsors do not need to interrogate medication event data – that’s done by over seventy algorithms that are used to detect problematic behaviors. (97% accuracy rating)

Biological markers: This involves measuring drug levels in a patient’s blood or urine samples. This method provides objective and accurate information on medication adherence. However, it is expensive and may be affected by factors such as drug metabolism and individual variability. Moreover, due to the sampling frequency, the results are sparse and only represent the participant’s adherence in the days leading up to the visit. (70% accuracy rating)

Pill counts involve counting the number of pills or doses patients return at each study visit. This method is relatively easy to administer and requires no special equipment. However, it relies on patients’ honesty in returning all the medication and may not detect missed doses. (60% accuracy rating)

Self-report: This involves patients reporting their medication adherence through questionnaires or interviews. This method is easy to administer and inexpensive. However, it is subjective and may be influenced by patients’ social desirability bias. Moreover, it adds a significant burden for participants. (27% accuracy rating)

Each of these methods has its strengths and limitations, and the choice of the method should depend on the specific requirements of the trial and the resources available. Combining multiple methods can provide a more comprehensive assessment of medication adherence.