Explore comprehensive guides, crafted by expert eCOA scientists and implementation specialists, to help you navigate the unique challenges associated with implementing clinical outcome assessments (COAs)
Patient reported outcomes (PROs), one type of clinical outcome assessment (COA), are becoming an increasingly important part of clinical drug development. Obtaining patient experience data through the patient perspective is increasingly important in regulatory decision making, in supporting health technology assessments, and in informing sponsor go/no-go decisions. While in some disease areas, patient-reported outcomes data may form the primary study endpoint (e.g., pain, epilepsy), in other areas PRO data often remain important secondary endpoints.
While some sponsors and CROs already have in-house COA specialists, this set of rapid how to guides will help all sponsors and CROs expertly navigate the nuances and specific challenges associated with selecting and implementing patient-reported outcome measures (PROMs) in clinical trials and clinical development programs.
Each of our guides has been written by our in-house eCOA science and implementation specialists, and are designed to address a unique challenge associated with the planning and implementation of patient-reported outcomes in your study protocols.
Each is in the quick-to-read format of a one-page infographic, and each contains links to more detailed materials.
On-site and at-home completion of patient-reported outcomes are typically performed using electronic solutions or using paper forms. In this how to guide, we evaluate the factors to consider when choosing between electronic and paper implementation.
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Selecting a PROM that matches the protocol objectives and measures the required concepts of interest effectively is of vital importance. In this how to guide, we explore how to select the right measures for your clinical trial.
If you’ve decided to use ePRO, your choice of whether to use an app or a web-based solution will depend on where and how the solution is to be used. You may also have the choice to provide patients with a study device or to use their own (bring your own device – BYOD). This how to guide helps you to expertly navigate these choices.
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Some populations, such as the elderly or pediatric populations, may require particular considerations to implement a COA measurement strategy effectively and appropriately. In this how to guide we explore the main considerations associated with special populations.
When using validated measures, it’s important to understand how to work with license holders and authors to ensure the correct permissions are obtained, the correct versions sourced, and contracts are in place. Signant’s in-house scale management team enable you to navigate this easily, and our how to guide describes the essential steps in the process.
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For some studies, you may decide that the best approach to measure the protocol’s concepts of interest is to develop your own patient-reported outcomes measure, for example, a symptom diary specific to the disease you are studying. In this how to guide, we explore best practice principles in developing and validating your own patient diary.
If you found our how to guides helpful and want to learn more, enroll free of charge to our eCOA explained video curriculum, with detailed content on a variety of topics developed and presented by Signant's in-house experts.
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