Throughout the course of a clinical trial, sponsors must collect strong, repeatable data in order to demonstrate the efficacy and safety of a drug. In trials that rely on participants taking drugs on a set, in-home schedule, poor adherence can greatly impact the results. In fact, research from the New England Journal of Medicine shows that only 34 percent of trial participants take medications as prescribed.
While the intent of a trial is to determine if a drug works as planned, sponsors have not historically had an objective means to prove whether a drug is not working post-market launch. However, technology has become increasingly sophisticated; and subsequently, digital health technologies are offering pharma organizations better insight into efficacy in the real world. In recent years, we have seen new, innovative devices and technologies entering the market, including smart pill bottles, connected inhalers and ingestible sensors from device manufacturers. Some pharma companies are even creating their own sensors to embed in medications to track adherence.
Ensure medication is taken — on schedule
With adherence to dosing and intervals being key in demonstrating efficacy, sponsors can now have more visibility into a drug’s true outcome. Digital health tools are enabling sponsors to collect real-time adherence data in order to track not just that a participant took a medication, but also the time at which it was taken and the dose taken. This data can even be used to uncover patterns in medication-taking behaviors and to remove non-adherent participants from a trial.
Send reminders to trial participants
By knowing which participants did not take their medication or adhere to the dosing interval, sponsors can choose to intervene and encourage positive medication-taking behaviors. For example, if a participant misses a dose, the sponsor is alerted and triggers a reminder to be sent via a call, text or email to the participant, reducing negative behaviors that can compromise a trial. There are also smart pill bottles that beep or light up when a dose is missed to remind the patient to take the medication.
As predictive analytics and data science technologies continue to advance, sponsors can apply machine learning to predict when a patient is likely to stop taking their medication, and send notifications or contact the patient to encourage adherence and positive behavior.
Enable adaptive trial design
Real-time visibility into adherence also allows sponsors to design data-driven, adaptive trials. Armed with this data, sponsors can feel confident making adjustments to protocols based on actual indicators, while eliminating outliers that are due to poor adherence.
As the capabilities of medication adherence technologies continue to expand and the pharmaceutical industry increasingly recognizes the benefits of their use, the number of clinical trials utilizing these technologies is expected to grow significantly in the years ahead.