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 years, clinical outcome assessments (COAs) have been critical in helping measure the effectiveness of treatments tested in clinical trials. Not only do COAs help demonstrate the efficacy of a given treatment, but they also reflect a participant’s symptoms, overall mental state, and quality of life.
Within the last decade, electronic clinical outcome assessments (eCOA) have begun replacing their hard copy forms. This shift from paper is attributed to eCOA's ability to facilitate data capture in a manner that better fits into participants’ lives while providing better data and easier experiences.
Why eCOAs prevail where paper fails
Simply put, eCOAs are less prone to data errors. This is because paper COAs fail to meet the basic ALCOA standards held to clinical research information in that they are not often attributable, legible, contemporaneous, original, or accurate. For example, some participants report completing paper diaries about their treatment outside of the required research windows, a practice referred to as forward filling. In fact, 45% of patients in a pain study forward-filled at least once ( “Patient Non-compliance with Paper Diaries,” Stone, A., British Medical Journal, 2002).
In other cases, altruistic participants can fall victim to what’s known as “the good patient effect,” where they report feeling better than they are when reviewing COAs with site coordinators and PIs.
Capabilities that improve oversight and data collection
We understand that eCOA has the power to ease clinical research for all stakeholders. When developing and refining our eCOA offering, we consult with our own Participant & Caregiver Network (PCN) (a network of patients, caregivers, and patient advocates) to provide feedback on design.
Knowing this, we purpose-built our eCOA and the wider platform it fits within in a way that fosters better oversight, and better clinical trial data.
Guiding the participant’s journey
One of the core parts of Medable’s 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.
Our offering helps 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, taking their trial medication, completing a diary, and completing a Televisit with their PI. Outside of the Televisit, our eCOA will only unlock and prompt the participant to complete the necessary tasks at the time needed. When combined with psychosocial design, this helps guide the participant in a stressless, seamless way.
Quality by design
Compliance is an essential key to creating better clinical trial data. With paper COA, data could be wildly exaggerated or incorrect, as there were no controls for what or when participants recorded information.
As mentioned above, our eCOA offering uses reminders and notifications to help remind participants to complete tasks. Here, our notification philosophy is impacted by the psychosocial aspects of everyday life.
For instance, we’ve observed that setting up reminders around the times that people commonly complete normal tasks that are standardized in their life such as brushing their teeth at night, eating breakfast, etc. Once notified, it’s only a few clicks or taps until the participant is entering information.
These design choices help participants gain familiarity and trust with eCOA that it and the larger trial won’t interfere with the participant's daily life.
Medication adherence remains a big issue in healthcare, both in and out of clinical trials. Participants who don’t adhere to the trial’s treatment schedule run the risk of skewing data.
While daily prompts are key in helping participants remember to adhere to medication schedules, they also help prevent treatment mishaps, adverse events, or skewed data.
Within Medable’s eCOA, 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.
Doing this not only helps foster better adherence and compliance but allows for greater participant safety. This is because sites and PIs can look towards any possible symptoms or clinical events in correlation with when an investigational medication was taken.
In addition, eCOA enables sites and sponsors to enable live triggers to healthcare providers in instances where the participant has indicated they’ve missed a scheduled dose.
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.
Adding up the impact
The total impact of these features is that sites and sponsors can count on eCOA to deliver higher quality data than their paper counterparts while providing better oversight and better safety.
To learn more about Medable’s eCOA offering or to speak with one of our SMEs about COA questions surrounding your trials, click here.