“The number of clinical trials using electronical clinical outcome assessments (eCOAs) has doubled during the last five years,” according to Piero Bindi, Associate Director eCOA Library IQVIA.
While there may be a greater use of eCOAs in recent years, the question of why is not as clear but the leverage of data leads the way.
Clinical outcomes assessments (COAs) are developed for a specific application, but they hold data that has value for researchers, patients, and stakeholders. IQVIA’s eCOA library is a collaborative one and the robust resource of shared knowledge lends itself to the potential push for more eCOAs.
Bindi explained that in the clinical research environment, stakeholders want to gather data from the perspective of patients, caregivers, and site staff and eCOAs have the ability to give researchers insight into care journeys.
He added, “eCOAs offer a direct line to patients, capturing real-time insights about their experience with their disease, the trial, and a treatment’s impact on their quality of life. These digital tools provide patients a chance to be heard while providing sponsors with quantitative and qualitative data to track the influence and efficacy of a treatment.”
This insight into care journeys and providing sponsors to track data through a trial can be an effective way to capture data remotely during a decentralized clinical trial (DCT). Bindi asserts that sponsors are looking to shift to DCTs and but are still in need of deeper insights as the industry also shifts toward a more patient-centric drug development landscape.
He explained, “COAs are increasingly becoming an important benchmark for regulators and payers to measure the quality of a new treatment.”
Sponsors often re-create standard eCOAs for every trial, but Bindi explained that libraries can provide sponsors with instant access to pre-built eCOAs for their research needs and can be immediately implemented in trials across various disease categories.
He said, “A library can shorten the time of implementation down to a matter of days in some cases and ensure consistency in the data being collected.”
Collaborative libraries such as IQVIA’s can offer major benefits to stakeholders. Yet, due diligence to copyright is imperative.
Bindi told us that at IQVIA the team follows a “weighted scoring system” to prioritize approval of assessments in its library. The scoring system includes criteria such as if the assessment is used in studies currently recruiting patients and are run in clinicaltrials.gov, if it’s been used in past or current studies, and if it has be included in any of IQVIA’s proposals within the year.
The system, according to Bindi, puts the “more sought after eCOA assessments” at the top of the pile to be vetted, approved, and ready for use.
Approved assessments in the IQVIA eCOA library include those from Oxford University and EORTC.