Clinical trials are long and complex, requiring deep commitments from all stakeholders for their success, including sponsors, CROs, sites, and patients. Sponsors and CROs can greatly benefit from easing the patient burden and helping each unique patient adopt the requirements of the study into his or her life. This investment will not only engage patient in the study but will create a long-term connection with the patient during commercialization or follow-on studies. Behavior science motivates similar shifts in patient experience in many other industries, and if applied correctly to clinical trials, it can connect sponsors with their patients in a new and exciting way. A recent study by Brite Health put this to test, and using a behavioral technology platform showed 3 times increased patient engagement, and 24 times more data recorded.
Patient noncompliance and dropout are two of the costliest issues in clinical trials. The cost is not only in the budget required to recruit additional patients but also in delaying the time to market. The numbers are staggering: On average 40 percent of patients in clinical trials stop taking the investigational drug after only 5 months, and 30 percent drop out. For sponsors, this translates to $18+ million dollars in additional capital required for a Phase III trial, to enroll enough additional patients in order to maintain equivalent statistical power.
"A pillar of any behavior change framework is understanding the unique differences between people and delivering the elements of the framework at the right moment"
Over the last few years, the pharmaceutical industry as a whole has begun to adopt a focus on patients in different stages of drug development, including clinical trials. The 2016 21st Century Act and the FDA have been instrumental in reinforcing this focus. Kicking off a 5-year guidance development process in 2017, FDA began requiring a public comment summarizing the patient experience data reviewed as part of an approved NDA. More recently in May 2018, Congress passed an additional $300M budget for the FDA to expand the use of virtual clinical trials and patient engagement applications, and provide an annual report on the actions pursued as part of this effort.
Today, there are different solutions to the problems of patient noncompliance and dropouts, but none are very effective or developed with a true patient focus. They are either prone to misuse by patients, focus purely on tracking compliance instead of improving it or distribute a single generic solution with no regard to the unique needs and preferences of each patient.
Pill-counting is a common way of recording compliance and studies have shown its many drawbacks including patients over reporting compliance when confronted with perceived punishment at a site visit. Diaries and interviews are also prone to over reporting, but also focus purely on measuring compliance without influencing it. There are few solutions that try to improve compliance by sending reminders to patients to prevent cases of unintentional non-compliance, but they are not tailored to each patient, and as a result, are delivered at the wrong time for the patient. Another mobile solution tracks compliance by analyzing a video of a patient taking the medication, but this also focuses on simply recording compliance with a perceived punishment strategy from the patient perspective, without motivating patient behavior change to increase compliance.
A truly effective and patient-focused solution to the problems of patient noncompliance and dropout needs to motivate behavior change at a fundamental level uniquely for each patient. Other motivational models such as carrot and stick, competition, and rewards are only effective in the short run and only for a subset of the patient population, making them ineffective for the long, complex and diverse nature of clinical trials.
Motivating behavior change is a big challenge in many different fields, and it is studied by an entire academic field called Behavioral Sciences. There are many behavior science frameworks developed and studied with the goal of harnessing each individual's unique motivation, and triggering the desired outcome through usable tools. These frameworks can be applied in clinical trials to naturally change patient behavior to adopt the complex and strict requirements of a study, and as a result improve patient engagement, compliance, and retention.
A pillar of any behavior change framework is understanding the unique differences between people and delivering the elements of the framework at the right moment. As an example, a leading behavior change framework developed by BJ Fogg, calls for motivating behavior change by requesting hard tasks from the patient in rare moments of high motivation to pave the path for new hard tasks in the more frequent moments of low motivation. Recognizing these moments of motivation requires a deep understanding of the patient, from their daily schedule to their interests, to the coaching tone that motivates them best.
A comprehensive de-identified patient profile developed with machine learning over time and using many data streams can inform behavior change frameworks, to create patient-first engagement within clinical trials. This deep understanding of the patient generates value not only in clinical trials but other phases of drug development such as recruitment and commercialization. Brite Health, a technology platform for patient compliance and retention, helps sponsors increase patient engagement in trials by delivering tailored experiences to each patient in order to seamlessly integrate the clinical trial in his or her life, and drive behavior change.
A true focus on the patient can deliver the results the industry and patients desire: clinical trials completed on time to take life-saving drugs to market faster, with great patient experience throughout the study. A recent study tested the efficacy of applying behavior change models tailored for each unique patient on overall study compliance. The results were staggering and showed 3 times more compliance and 24 times more data recorded during the course of the study.
The future of clinical trials holds the promise of virtual and hybrid trials backed by the growing technology trend and consumerism, as well as new FDA mandates and increased budgets. As an industry, we need to take steps towards bridging the gap between patients and clinical trials and knowing our patients can be the most effective backbone for all patient-centered initiatives.