OR WAIT null SECS
© 2023 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
Evolving mindsets are opening the door for industry to utilize new mediums for understanding patients.
Strong participant engagement is the cornerstone of effective, efficient clinical trials.But the patient, and their experience, has often not been a top priority in trial and technology design.
The costs—both financial and human—of low participant engagement are high. On average, it costs $6,533 to recruit one patient to a clinical study, and the cost of replacing patients is even higher.1 The average cost to recruit a new patient if one is lost due to non-compliance is $19,533.2 And, approximately 85% of clinical trials fail to retain enough patients.
Mindsets about patient-centricity and the technology needed to support it are changing and this is welcome news for patients, sponsors, and investigators alike.
As pharma and biotech expand their focus on patient-centricity, there is a clear role for the science of behavior. Behavioral science explores the complex interaction between individuals and their environment to enable a better understanding of what factors motivate behavior and how they might impact decision making.
Technology is also an indispensable tool in supporting patient-centric study design as it can be utilized to facilitate behaviorally-driven experiences for participants. Next-generation eCOA/ePRO technology that incorporates human-centered design and behavioral science principles can be a highly effective tool for elevating patient engagement and maintaining it throughout a trial.
Like trial protocols themselves, many clinical trial technologies have been designed from the perspective of sponsors and investigators—and not participants. For example, digitizing paper-based questionnaires for mobile devices without consideration for patient usability and the new digital medium. This approach tends to push the key stakeholders in a clinical trial apart—resulting in a negative impact on participant engagement and trial outcomes.
This reality aligns with what we know about the reasons that patients drop out of clinical trials. In addition to financial barriers, the most common reasons that patients cite for attrition include inconvenience, poor communication, and feeling underappreciated. Technology that does not incorporate human-centric design can proliferate each of these factors.
Clinical trial technology can be cumbersome to use, confusing, require participants to enter data on study-specific mobile devices instead of their personal phones or tablets, and have requirements, such multiple log ins, that are too high for trial participants who are frequently experiencing significant health-related challenges.
Digital technology shines brightest (and is most effective) when it starts with human relationships and behaviors and then introduces technology into the equation to enhance and advance outcomes.
We see effective use of human-centered design and behavioral models in the consumer technology space. For example, streaming services, such as Netflix, continually learn from user preferences and tailor the experience for the user. Ecommerce sites rely on intelligent navigation and extensive personalization based on previous behaviors to enhance the shopping experience and deliver hyper-personized content to consumers.
Clinical trial applications have not evolved at the same rate as consumer technology. Many are built on the back of clinical data-based systems, such as electronic data capture applications. Primary users of these systems are clinical and data specialists. Therefore, simply extending these systems will not produce a patient-centric platform that is the foundation for the successful utilization of behavioral science.
To enable a truly patient-centric approach to clinical trials, the technology supporting them must be designed from the ground up to focus on and optimize the participant’s experience. Integrating behavioral science into the design of solutions that capture patient input, such as eCOA/ePRO platforms, can further personalize and optimize a participant’s trial experience, elevating engagement and data quality to new levels.
Harnessing powerful behavioral science principles, including reinforcement, motivation, framing, and habit formation allow a linear experience to become responsive and targeted. Leveraging these concepts within study design and in the technology that supports clinical trials, including eCOA/ePRO solutions, greatly increases the patient-centricity and effectiveness of the trial experience.
The utilization of behavioral science methods, theories, and frameworks allows the user experience to be focused on the realities of the study. This includes messaging, behaviors, actions and workflows that fit the trial design and data capture requirements, but most importantly reflects and responds to a participant’s real-life trial experience.
Examples of the convergence of behavioral science, trial design, and technology to drive more engaged patients include:
Motivation – The ability to motivate participants to engage with studies is deeply rooted in behavioral science. Understanding and reflecting a user’s underlying motivation is key to maximizing engagement and avoiding drop out. Motivation for taking part in a clinical trial can vary, and it is important to ensure messaging and the information presented to participants aligns with their values and motivation. Communicating frequent study updates, stories that relate to the condition, the value of and appreciation for taking part in the study can make a huge difference to engagement. But these messages need to relate directly to a participant’s underlying motivation, which might relate to their specific condition or be philanthropic in the case of real-world studies. Human-centric clinical trial applications support this type of critical communication and deliver it at the optimal time, such as after data entry or site visit and in response to low compliance.
Framing – Gain- or loss-framed messaging, delivered directly to patients via eCOA/ePRO platforms, can be used to ensure that patients are most effectively activated to engage with the trial at key touch points. This includes message framing around visits and questionnaire reminders to ensure the language and prompts are optimized to target the right behaviors, e.g., attending visits or completing diaries.
Reinforcement – Reinforcement increases the likelihood of a target behavior happening again. The use of scheduled reinforcers in a study can be as simple as providing stipends for data entry or milestones met. Varying the messaging or timing in the study design can increase the engagement by harnessing a variable reinforcement mechanism. These reinforcers delivered directly to patients via solutions such as eCOA/ePRO platforms, can help promote a target behavior, such data entry.
Habit formation – To ensure consistent and timely data entry, it is important to create a streamlined process. The use of habit-forming behavioral techniques can be hugely beneficial. An example is creating a tactile and responsive interface for an eCOA/ePRO application that allows users to quickly enter data using familiar a method. The use of swipe gestures has been shown to create muscle memory, ensuring that regular data entry becomes habit and part of a daily routine. In addition, pairing daily data entry tasks with real-world tasks helps embed habit-forming behaviors, resulting in a subconscious prompt to engage.
More complex behavioral models can be created using these principles, such as developing an engagement feedback cycle that greatly increases study engagement. The model supporting the engagement feedback cycle identifies and measures participant challenges, and then determines the steps needed to maintain or increase engagement. The patient’s experience becomes personalized, dynamic, and responsive, either via automated interventions or sites taking recommended actions.
Trial protocols and the technology that supports them must put the human at the center from the start. Incorporation of behavioral science in the development and deployment of technology, such as eCOA/ePRO platforms, is an important foundation. Successful platforms are easy-to-use, provide the right information and experience at the right time, and deliver effective messaging to maximize engagement. While this is no easy task, industry leaders focused on putting the patient first are delivering powerful innovative solutions that are elevating engagement, accelerating research, and improving quality of life for many.
Ben James, chief design officer and co-founder, uMotif