Studies have shown that adherence to intervention protocols is higher in clinical trials than in non-research settings. In fact, mean clinical trial adherence rates can range from 43% to 78% among patients being treated for chronic conditions. In contrast, an estimated 50% of patients with chronic conditions fail to take their medication properly. While there is still no consensus for the standard around adherence, many clinical trials consider 80-95% to be acceptable for adequate adherence.

Real-world adherence has traditionally been poorly addressed, to say the least. Narrowing the gap between research and non-research adherence is more important than ever, and now possible thanks to the rise in decentralized and hybrid clinical trials.

 

What is adherence? 

The World Health Organization defines adherence as “the extent to which a person’s behavior – taking medication, following a diet and/or executing lifestyle changes, corresponds with agreed recommendations from a healthcare provider.” 

Adherence is essential to the success of a clinical trial. Let’s take medication adherence in a clinical study, for instance. For sponsors, low adherence to medication compromises the drug’s efficacy, creates costly approval delays, leads to flawed data, erroneous safety assessment, and potential trial failures, and jeopardizes the study. For patients, poor compliance can increase morbidity, reduce quality of life, and inflate medical care costs. In fact, a recent study estimated that 125,000 deaths are due to medication non-adherence, costing the US $105 billion every year. A 2001 review of twenty-two clinical studies found that “as adherences decreases so do the treatment benefits.” 

 

The stumbling blocks to optimal adherence. 

Why don’t patients comply with study protocols? The biggest culprits: lack of communication and unclear information between healthcare professionals and patients. 

Most often, participants don’t fully understand what is being asked of them and have limited access or knowledge of how to use the investigational product or medicine. In some cases, they are faced with complicated dosing regimens, fear adverse side effects, or simply forget. In other cases, during the trial they perceive no benefit and are afraid to communicate with healthcare providers. Establishing trust, transparency, and clear communication in a blame-free environment between researcher and participant is key to optimizing adherence in a clinical trial. 

 

New metrics for assessing adherence

The traditional methods of assessing adherence are outdated. In drug trials, researchers measure adherence by analyzing blood or urine samples, or more tediously, by counting the number of remaining tablets. They also can monitor the date and time of patient diary and questionnaire entries, analyze prescription refill rates, and study physiological markers. However, these conventional adherence metrics lack precision, efficiency, and often overestimate adherence levels. 

As decentralized clinical trials become the leading model for an increasingly digitized world, digital adherence technologies (DATs) have become key to assessing adherence with optimal objectivity and accuracy. In a clinical trial, DATs help clinicians identify and capture real-world, real-time changes, key in remote patient monitoring. The clinician is instantly able to reach out to the participant and provide guidance and support. As healthcare professionals gain a better understanding of a medication and its side effects, the newer technology-based tools improve the therapeutic product’s safety and efficacy. 

The most common DATs include smart pills or smart packaging, where an electronic microcircuit is attached to the medication packaging; each time a patient takes their medication, it generates a time stamp that transfers to a software system which researchers can access. Other typical digital adherence measures include mHealth, electronic reminders and notifications, and automatic refills. 

 

Implementing adherence-based compensation in your next clinical trial.

Promoting adherence may seem costly, burdensome, daunting even. But our team has found a particularly compelling strategy to enhance adherence in your next clinical study. We’ve pioneered a new metric that not only optimizes participant adherence but also boosts engagement and retention, and is free. Three words: adherence-based compensation.

What’s in it for you?

  1. Create monetary or non-monetary compensation when your participants reach specific milestones.
  2. Take any ePRO and tie it to a points-based system. With a gamified experience, you’re able to see how your participants’ actions are getting closer to the study’s compensation.
  3. Forget about tedious reminders. Our in-app notifications and automated warning notify participants to complete their e-diary study questions or prompt them to record their symptoms in our video ePROs. 

Adherence has never been this easy and efficient, for both researchers and participants. Join the paradigm shift and empower your participants to become key decision makers in their health care. 



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