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Blog
Real world data in real time
How eCOAs are changing the clinical research workflow
Frederic Sibeaud, Director, eCOA Data Management
Oct 25, 2021
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Electronic clinical outcomes assessments (eCOAs) don’t just simplify data collection. They give researchers almost instant access to patient data, which accelerates their ability to identify trends and make decisions. The impact of this speed and agility on a trial is that months can be cut from the duration, while lowering costs and mitigating risks, giving sponsors a powerful new tool in the clinical landscape.

Paper takes forever

With traditional paper-based diaries, researchers have to wait weeks to collect data when patients submit them at on-site appointments. Those paper documents can then pile up for weeks before they are transcribed into the database for review.

That means researchers may wait months before they can review any patient reported outcomes (PROs) from the trial population. It’s a significant front-end delay that adds weeks to the trial and slows decision-making.

With eCOAs that process is transformed. eCOAs are digital assessment tools that capture data directly from the patient via virtual questionnaires and diaries. As soon as the data is recorded, it is transported to the trial database, with no transcription or data transfer steps required.

That means researchers and sponsors can begin assessing PROs on day one of the trial. The impact can be profound.

The many benefits of eCOA

That near real time insight can help sponsors create safer trials, while providing financial and strategic benefits that may give them an edge in the marketplace. These benefits allow sponsors to:

  • Speed start up. IQVIA has a library of existing eCOAs, and an agile development process that allows sponsors to build custom eCOAs almost overnight. This can cut 12+ weeks from the upfront development process compared to other eCOA providers, enabling sponsors to launch trials faster, potentially shortening the trial and accelerating time to market.
  • 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 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.
  • Reduce required population size. If early eCOA data strongly indicates that safety and efficacy endpoints are being met in existing patients, the sponsor may choose to cap recruiting because the data verifies the expected outcomes.
  • Make faster go/no go decisions. If a treatment isn’t working as expected, having rapid access to eCOA data can accelerate a sponsor’s decision to cut their losses. This can save sponsors millions of dollars, which could be funneled to other promising drug candidates.
  • Beat competitors to market. The rapid start up and speed to data can potentially shorten the trial and accelerate a drug’s path 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.

Regulators and patients expect the patient’s perspective to be represented in clinical research. eCOAs give sponsors a way to capture that perspective quickly and concisely, while accelerating their ability to make decisions about the benefits of the therapy. The speed and agility eCOAs provide benefits everyone in the clinical landscape, making them an essential part of the future of clinical research.

Related solutions

eCOA

Fast, flexible and proven, IQVIA’s industry-leading electronic clinical outcome assessment (eCOA) platform ramps up efficiencies, delivers real-time data, and sharpens insights through best-in-class technology and a better patient experience.

eCOA FAQ

Explore our Frequently Asked Questions (FAQ) page to learn more about general industry eCOA topics and also specific details about our IQVIA eCOA solution.

eCOA Demo Videos

In these short demo videos, learn more about some of the key capabilities within the IQVIA eCOA platform including how to easily create an assessment, utilize the AI design tool, access automated screenshots and documentation, export/import translations, and view study data and reports.

Patient Engagement Suite

Technology informed by unparalleled Decentralized Trials (DCT) operational experience and delivered at global scale.

IQVIA Technologies

Combine data science, technology, and analytics driven by artificial intelligence to support new efficiencies and business insights -- without additional capital investment.

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