Direct-From-Patient Data Capture With eCOA

The rapid start-up and speed to data can shorten a trial and accelerate a drug’s path to market. eCOAs capture insights in real time about patient experiences with their disease, a trial and their quality of life on any new treatments. This kind of a tool provides patients a chance to be heard while giving sponsors quantitative and qualitative data to track the efficacy of a treatment.

This real time data that sponsors are able to leverage also allows them to:

• Adapt to subpopulations of interest. If sponsors are following an adaptive trial design, eCOA data can help them identify sub-populations who are experiencing better or worse results early in the trial, allowing them to shift course midstream. This early data may drive them to add or drop arms, adapt protocols, or modify inclusion/exclusion criteria to draw those patients most likely to respond to the treatment. That can help them generate the best possible results for their regulatory submissions.
• Predict potential risks before they become serious. Early patient recorded outcomes (PRO) data collection allows researchers to monitor patients and detect trends, such as poor sleep or increased pain. Because the data is instantly available for analysis, researchers can identify potential risks sooner so they can respond proactively.
• Beat competitors to market. The ability to accelerate start-up and speed to data can potentially shorten the trial and reduce time to market. This not only cuts the cost of the trial, it could help sponsors establish themselves as the first treatment in the market to address an unmet medical need. The impact of that can be huge. First-in-class drugs are more likely to be established as the standard of care, and to have a greater market-share advantage. One study found that when the first mover is a large pharma company, that advantage is worth greater than ten market-share points.
• Stay connected with remote patients. The pandemic forced many sponsors to adopt decentralized clinical trials (DCT), using telehealth, home health, and remote data collection. eCOAs gave them the tools to continue to monitor the patient experience, and to provide another conduit for patients to share data and stay engaged in the trial. DCTs are expected to be a permanent part of the trial landscape going forward, making eCOAs an important tool for patient engagement.