This insight brief details how we've flipped the eCOA development lifecycle upside down to optimize real-time, direct-from-patient data collection with IQVIA eCOA.
eCOAs are a clinical research innovation that improve the quality of data being collected from patients and address the need for a more patient-centric trial environment. These assessments capture outcomes from the patient’s perspective through a variety of validated measures, amplifying the patient’s voice while providing sponsors with vital information about the trial experience and patients’ quality of life. This unfiltered approach to collecting patient feedback also provides regulators and payers with new insights into treatment benefits, increasing the likelihood of approval and optimal reimbursement.
The value of these tools is undisputed, but the way they are developed by many vendors, using a waterfall methodology of software delivery, is highly inefficient wasting valuable time and increasing the likelihood of downstream design changes, defects, and ultimately causing delays in being ready for first-patient-in.
Instead, IQVIA is taking a more agile approach to eCOA development. Using our novel IQVIA eCOA platform and a collaborative, iterative design philosophy, our designers can produce a fully functional eCOA in a day.
This evolution in eCOA development is cutting months from the trial planning process, accelerating first patient in, and helping sponsors reduce time, cost, and risk in the trial environment – ultimately becoming another tool to help bring new therapies to patients faster.
The value of eCOA tools is undisputed, but using a waterfall methodology of software delivery is highly inefficient... IQVIA is taking a more agile approach to eCOA development and can produce a fully functional eCOA in a day.
ECOA: STRUCTURED PATIENT FEEDBACK
Capturing the patient voice in clinical research has become a top priority for the biopharma industry. Part of the pressure to become more patient-centric is coming from industry stakeholders. Patients want to play a more active role in trial planning and data collection as a condition of participating in trials. Regulators and payers are also interested in hearing the patients’ perspective, and increasingly seek evidence of patient feedback when evaluating the safety and efficacy of a new drug.
Biopharma leaders are pushing this trend as well because they see the value of integrating patient feedback into their clinical trial and data collection.
eCOAs address all of these needs by providing structured assessments that capture the patient experience in ways that are measurable and meaningful. Sponsors can use the resulting data to shape their drug discovery and development strategies, improve clinical design, win regulatory support, and engage with healthcare centers and physicians who are focused on improving their patients’ quality of life.
LOST IN THE WATERFALL
The benefits of eCOAs are clear, but the way these assessments are typically designed within an EDC, Portal, ePRO, or traditional eCOA system adds months to the trial planning process. Our research shows sponsors spend an average of 16-20 weeks designing, building, tweaking, and validating eCOAs for every assessment used. We’ve also found deadlines are often missed due to miscommunications during handoffs in a traditional process.
This is a common challenge when project teams rely on a waterfall software development approach. In these projects, stakeholders develop a set of requirements for what they need, then hand it over to a development team – who is not typically involved in the planning process – and wait weeks, or even months, for the development team to bring back a finished product. Only then does the sponsor see that their vision was lost in translation and tangled with false assumptions of the requirements.
By that point, ten or more weeks will have passed, and the eCOA development has become critical path to firstpatient-in, leaving sponsors to make a tough decision: use an imperfect tool even though it’s not exactly what they wanted, or delay the trial to correct it.
This kind of dilemma happens all the time with waterfall projects, due to handoffs, remote team communications, and disparate development process steps. But IQVIA is taking a different approach.