How to determine the best assessment for your clinical trial design

J C Wilson, product manager for electronic clinical outcome assessment (eCOA) at data analytics firm IQVIA, provides an Expert View on the changing landscape of clinical trial design.

The pandemic revolutionized data collection and patient engagement in clinical trials.

Although the life sciences industry has been historically cautious to adopt emerging technology trends, the sudden shutdown of in-person trial sites in adherence to safety protocols left sponsors and researchers with no choice but to adapt with more agile tools for remote data collection.

Electronic clinical outcome assessments (eCOAs) ultimately emerged as a key asset in the functionality of decentralized clinical trials (DCTs) by providing clinicians, patients, and caregivers with a simple way to record data and insights without ever setting foot in a clinic.

Moving forward, eCOAs will continue to be an integral component of the clinical trial landscape. When deciding on the best COAs to implement, sponsors should consider several factors throughout the design process.

Trial design considerations

While clinician-reported outcomes (ClinROs) and performance outcomes (PerfOs) must be completed by medical professionals, patient reported outcomes (PROs) and observer reported outcomes (ObsROs) are often more subjective in nature, as they are completed by patients and caregivers.

For patients and caregivers to accurately complete these assessments, sponsors must equip them with training and a support structures that may not always be part of the initial trial design.