Effective monitoring of medication adherence is vital for the success of any clinical trial. Yet too often archaic, biased methods are used for compliance monitoring. Dr. Bernard Vrijens from AARDEX Group explores new guidance on clinical trial quality and argues digital adherence monitoring should be a ‘no-brainer’.
Failing to effectively monitor adherence in clinical trials can have far-reaching implications – from an inability to provide reliable safety and efficacy data to significantly increasing costs and delaying access to treatment. Yet, despite its obvious importance, there is huge variability in the assessment and reporting of medication adherence in clinical trials.
New guidance for clinical trial quality makes it clear that medication adherence is a must have alongside randomisation, blinding and appropriate statistical analysis. However, a policy gap remains because no one is asking for a valid method to measure adherence.
To ensure medications are effective, and make clinical trials more efficient, we need to move beyond out-of-date methods and adopt digital adherence monitoring.
Clinical Trial Quality Guidance
The latest version of ICH E6(R3) was published in January 2025. It said strategies should be implemented to avoid, detect, address and prevent the recurrence of serious noncompliance with good clinical practice (GCP), the trial protocol and applicable regulatory requirements. Appendix B. highlights the need to mitigate and eliminate risks to the safety and wellbeing of patients and the reliability of data. This includes strategies to monitor the participant’s adherence to treatment.
In 2024, the World Health Organization (WHO) published new guidance on best practice in clinical trials. The guidance, which advocates risk-based and proportionate approaches, aims to enhance clinical research efficiency and support sustained clinical trials that are always functional for endemic conditions and can pivot in times of emergency.
It highlights the need to facilitate and encourage adherence and ensure data collection, storage, exchange and access enables reliable and consistent analyses. The guidance also highlights the potential risks of low adherence. For example, in a randomised controlled trial (RCT) if participants receiving the active intervention are non adherent, the ability to assess any difference in outcome between that arm and a placebo arm of the trial is reduced. This increases the risk of a false conclusion being drawn about whether a meaningful difference exists between the interventions.
The WHO guidance also says monitoring should take a risk-based proportionate approach which focuses on the issues that will make a “material difference” to the participants in the trial and the reliability of the results. This includes adherence to the allocated intervention.
However, despite this recognition of the importance of medication adherence, and the need to reliably monitor and analyse data, there remains a clear policy gap – no one is saying how we measure it.
