In our “You asked, we answered” series, Medable answers questions submitted to SMEs during webinars, RFIs, RFPs, etc. in order to provide more education around digital and decentralized offerings.
As FDA Principal Deputy Commissioner Janet Woodcock said in a 2015 Clinical Outcome Assessment Public Workshop, “It turns out that what is really bothering the patient and what is really bothering the doctor can be radically different things...patients are true experts in their disease.”
For decades, Clinical Outcome Assessments (COAs) have been key to capturing a comprehensive picture of patient experiences and treatment outcomes in today’s research landscape. Integrating COAs into trial protocols not only bolsters the scientific integrity of our treatments but also enhances our ability to understand the real impact of interventions on patients.
Since the mid-2010s, electronic clinical solutions, like eCOA, have grown rapidly with a compound annual growth rate of CAGR of 13.7% between 2015 and 2020 according to ReportLinker. By now, it’s accepted that eCOAs and ePROs offer a number of advantages over traditional paper-based methods.
Some of these advantages include:
Increased accuracy:
Electronic data collection is less prone to errors than manual data entry and can be purposely built in a way that reduces errors at the time of entry.
Reduced burden:
eCOAs and ePROs can streamline the data collection process, saving both patients and researchers time.
Real-time data:
eCOAs and ePROs can collect data from patients in real time, which can be used to track their progress and identify any problems early on.
While these points are well known, we at Medable are often asked in webinars, requests for proposals (RFPs), tradeshows, etc. just how exactly eCOAs and ePROs foster better patient compliance with submitting data.
Since you asked, our answer is below, courtesy of Jessica Dolfi, VP of Solution Consulting.
Paper COA is prone to worse data collection
Simply put, paper Clinical Outcome Assessments (COAs) often fall short of meeting basic ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) standards due to inherent limitations in their manual nature.
Paper COAs are always at risk of failing to be attributable to the participant as they lack embedded attribution mechanisms, making it challenging to trace data back to its source reliably. Handwritten entries contribute to issues related to legibility, introducing the risk of misinterpretation and transcription errors. The contemporaneous nature is hindered by the delayed nature of data entry and the potential for retrospective completion, undermining the real-time aspect of data capture. Originality is jeopardized by the susceptibility to alterations, loss, or damage of paper documents during the course of a trial, most notably due to stains, ink smudges, tears, or missing items. Lastly, achieving true accuracy is impeded by the manual data entry process, increasing the likelihood of human errors and compromising the overall integrity of the data. In contrast, electronic Clinical Outcome Assessments (eCOAs) address these challenges by offering built-in features that align with ALCOA principles, ensuring data reliability, traceability, and integrity throughout the clinical trial process.
A real-life example of this can be seen in the practice of “forward filling”, a practice where participants report completing paper diaries about their treatment outside of the required research windows. In fact, a 2002 study indicated that 45% of patients in a pain study forward-filled their data at least once ( “Patient Non-compliance with Paper Diaries,” Stone, A., British Medical Journal, 2002).
Better compliance lies within real-time data
Perhaps the greatest asset eCOAs can offer is real-time data, which enables better understanding, oversight, and decision-making for almost every facet of a trial.
One of the primary advantages of real-time data in clinical trials is the ability to make prompt and informed decisions. With the continuous influx of data, researchers can identify trends, potential safety issues or concerns, and opportunities for trial improvement without delay.
This is in stark contrast to only receiving trial data and insights from participants at the time of their visits.
Quality by design leads to better data
eCOAs not only streamline data collection but also foster better adherence from trial participants. Electronic interfaces can be designed with user-friendly features that unlock only when necessary, reducing the burden on participants and encouraging regular, familiar and accurate data input.
Example: Guiding the participant’s journey
A good eCOA system is built around the idea of guiding the participant in a natural and seamless way. Oftentimes, clinical trials may have tens to hundreds of activities for participants to complete over the duration of the trial, and this can feel overwhelming for trial participants.
Top-tier eCOAs help ease the experience of participation by releasing tasks one by one, prompting them only at the time they need to be completed.
For example, let’s imagine a participant must complete three trial activities in a day, take their trial medication, complete a diary, and participate in a Televisit with their PI. Well-designed eCOAs will only unlock and prompt the participant to complete the necessary tasks at the time needed and provide notifications. When combined with psychosocial design, this helps guide the participant in a stressless, seamless way.
Example: Conditional question and branching logic capabilities
Let’s imagine a scenario where a participant is required to take study drug A if they’re experiencing headaches, or study drug B if experiencing stomach aches.
In this example, if a participant takes study drug A, then future diary questions are only geared towards collecting information related to drug A.
These question and branching logic capabilities are applied throughout all aspects of eCOA and the clinical trial, helping ensure better quality data at the point of entry. Additionally, the interactive nature of eCOAs allows for real-time validation checks, ensuring data completeness and accuracy.
Example: Notifications and reminders
Notifications and reminders play a pivotal role in fostering improved medication and data adherence within clinical trials. Timely notifications serve as essential prompts, reminding participants to take their prescribed medications consistently. This proactive approach helps mitigate the risk of missed doses, contributing to more accurate and reliable data on the medication's efficacy.
Additionally, participants are asked to log the time they took their study medication, while also confirming the number of pills or doses they took, as well as their actual shape and size. Participants are given images of their study drug and asked to confirm that what they took matches what’s on screen.
Reminders tailored to participants' daily routines can enhance the overall patient experience, making adherence to medication schedules more manageable and less intrusive. By aligning reminders with participants' habitual activities, such as daily routines or specific events, the process becomes more intuitive and seamlessly integrated into their lives.
Electronic ease of use and “bring your own device”
The adoption of eCOAs fosters a participant-centered approach by providing them with tools that better align with the modern technology experiences of their daily lives. Mobile applications and electronic devices make it easier for participants to engage with the study, leading to increased adherence to data collection protocols.
With the integration of “bring your own device” (BYOD), participants have the flexibility to use their own smartphones, tablets, or other electronic devices to engage with the study. This approach recognizes and capitalizes on the prevalence of personal devices in individuals' lives, making participation more convenient and accessible, and data submission much less cumbersome..
The big impact
The sum of these features is that sites and sponsors can count on eCOA to deliver higher-quality data than their paper counterparts while also providing better oversight for safety and compliance.
