It’s incredibly challenging to find a large and diverse group of patients that meets the eligibility criteria for a clinical study in the traditional study-based model. Upon identifying and successfully recruiting these patients, keeping them all engaged and involved throughout a trial is also difficult. 

With recruitment lagging in over 80% of clinical trials, it’s imperative to design these studies with patients in mind. By not achieving study recruitment and retention targets, the clinical trial will fall short of what’s needed for approval. The result is extended study timelines and increased spend to acquire the needed data. Given the already long timelines and high financial costs of clinical trials, these problems cry out for thoughtful solutions.

At Studion, our years of experience in designing eCOA solutions have taught us the key importance of patient-centered design in pursuing the goal of efficient and effective data collection. We know that creating an environment that works for patients is the way to ensure reliable data and a better, more meaningful outcome for each trial. 

What it Means to Design for the Patient

Paying lip service to the idea of designing for the patient is easy; actually doing it is difficult. 

Clinical trials are complex, involving many individuals, from the scientist writing the protocol to the operations teams trying to bring it to life to the vendor collecting, presenting, and storing the data. Each individual thinks differently about the tasks and processes they must complete to achieve specific objectives within the broader scope of the study. 

In other words, there are many potential points of failure. 

For us, patient-centered design means the following:

• We prioritize patient needs by understanding the differences across patient populations.

• We design concise, intuitive workflows and interfaces that don’t sacrifice usability and inclusion.

• We build data validation to assure quality with minimal user disruption.

• We consider patient fatigue in defining data collection volume because lower fatigue translates into higher compliance and data quality.

With these aspects in mind, we create custom digital experiences for clinical trials to meet everyone’s needs while remaining compliant with industry regulations. 

The Importance of Reliable eCOA Tech

Minimizing friction when using digital technologies to collect patient data throughout a trial is critical. In many instances, patients who experience a glitchy or hard-to-navigate system at first use will likely develop mistrust in it for the remainder of the trial. 

As such, study teams must ensure patients enrolled in their trials are using software subjected to rigorous development and validation such that information is properly and reliably recorded the first time patients fill it in—and for all subsequent data collection events.

At Studion, we’ve learned that incorporating rigor, reliability, and validity into designing clinical trial software is critical to the success of each stage of these studies.

Developing less buggy eCOA software reduces disruptions to data collection, streamlines data validation, and contributes to faster completion of studies.

As Jae Lohan, Director of Client Services at Studion, says, “Because we’ve worked on the more complicated enterprise-level platforms, we have a good idea of what a platform is capable of upon checking under its hood. We often find that we’re telling our clients what’s possible and what isn’t, and what’s needed for them to get to the next level in terms of scaling.”

Cultivating Patient Trust for eCOA Data Collection

When designing a platform that addresses the needs of large, diverse patient populations enrolled in a clinical trial, it’s critical to cultivate trust at each point of interaction between the technology and the patients. 

In general, traditionally underrepresented clinical trial participants may develop mistrust based on misinformation or the preconceived biases they had before enrolling in the trial. For instance, an older participant whose highest level of education is high school is more likely to be intimidated by a digital remote patient monitoring app than a younger, tech-savvy college graduate. 

So, recruiting diverse patient populations into a clinical trial requires building an intuitive and easy-to-use interface that simplifies their user experience. Likewise, a workflow that educates patients and their caregivers about best practices for collecting data using eCOA devices makes them feel comfortable about the process and their overall participation in a clinical trial. As these patients become more “trusting” of the entire digital experience, they are more likely to collect data in a correct and compliant manner throughout the study. 

Build a More Engaging Clinical Trial Experience

Achieving the right balance of rigor, reliability, and validity with a clinical trial solution will likely require several iterations to determine what works best for your specific clinical site, therapeutic area, or patient population. 

At Studion, we specialize in this type of iteration and have experience developing custom platforms to engage patients enrolled in clinical trials, irrespective of size, indication, or geographic location. 

We can help you build more engaging experiences for the patient populations you’re looking to enroll or those already enrolled in your clinical trial.