{"id":510567,"date":"2024-02-09T09:00:00","date_gmt":"2024-02-09T14:00:00","guid":{"rendered":"https:\/\/platohealth.ai\/ecoa-flexibility-in-clinical-trials-the-site-perspective\/"},"modified":"2024-02-09T09:03:06","modified_gmt":"2024-02-09T14:03:06","slug":"ecoa-flexibility-in-clinical-trials-the-site-perspective","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/ecoa-flexibility-in-clinical-trials-the-site-perspective\/","title":{"rendered":"eCOA Flexibility in Clinical Trials: The Site Perspective","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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Image Credit: \u00a9 Sergey Nivens – stock.adobe.com<\/em><\/p>\n<\/div>\n<\/div>\n

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As medical product development drives advances in medical knowledge, clinical trials continue to become increasingly complex, potentially adding burden to trial sites that already face challenges while executing a protocol. Electronic clinical outcome assessment (eCOA) data collection in clinical trials has increased significantly since the first implementations in the 1990s.1<\/sup> Evidence demonstrates how eCOA improves data quality2-5<\/sup> and potentially reduces the burden of paper-based data collection.<\/p>\n

However, sites report that eCOA can be disruptive, impact participant engagement and protocol compliance, and may feel that eCOA systems demand specific skills and resources.Consequently, there is a collective need to identify areas for simplification and flexibility to reduce that burden.<\/p>\n

In 2019, the Critical Path Institute launched the eCOA: Getting Better Together Initiative (GBTI) <\/em>to identify the root cause of issues with eCOA implementation in clinical trials. To address the clear need to embed flexibility in eCOA use, the Support Flexible Approaches to PRO Data Collection<\/em> project was launched.<\/p>\n

The project explored three areas via separate workstreams:<\/p>\n