电子临床结果评估（ECOA）不仅简化了数据收集。他们几乎可以立即访问患者数据，这加速了他们识别趋势和做出决定的能力。这种速度和敏捷性对试验的影响是，可以从持续时间中缩短几个月，同时降低成本并降低风险，从而使赞助商成为临床景观中强大的新工具。
纸永远
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.
这意味着研究人员可以等待几个月，然后才能审查试验人群的任何患者报告的结果（PRO）。这是一个重大的前端延迟，增加了数周的审判并减慢了决策。
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.
这意味着研究人员和赞助商可以在试验的第一天开始评估专业人士。影响可能是深远的。
ECOA的许多好处
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.iqviahas 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.
- 更快地做/没有去决定。如果治疗无法正常工作，那么可以快速获取ECOA数据可以加速赞助商减少损失的决定。这可以为赞助商节省数百万美元，这可能会向其他有前途的候选毒品提供。
- 击败竞争对手进入市场。快速启动和数据速度可能会缩短试验并加速药物的市场路径。这不仅削减了试验的成本，还可以帮助赞助商确立自己的第一种市场治疗方法，以满足未满足的医疗需求。这可能是巨大的。一流的药物更有可能成为护理标准，并具有更大的市场优势。一学习found that when the first mover is a large pharma company, that advantage is worth greater than ten market-share points.
- 与远程患者保持联系。大流行迫使许多赞助商使用远程医疗，家庭健康和远程数据收集采用分散的临床试验（DCT）。必威手机APPEcoas为他们提供了继续监视患者体验的工具，并为患者提供了另一个渠道，以共享数据并继续参与试验。预计DCT将成为试验景观的永久部分，使EcoAS成为患者参与的重要工具。
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.
