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NCT04214301 STUDY PROTOCOL An OpenLabel Preference Evaluation of BLI800 DOCUMENT DATE: 08/01/2019Braintree Laboratories, Inc. Protocol Number BLI800491Confidential Page 1 of 20An OpenLabel Preference
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Review the evaluation criteria and instructions provided by the organization or research team.
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Who needs an open-label preference evaluation?

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Patients participating in clinical trials
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Researchers studying patient preferences
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An open-label preference evaluation is a type of study or assessment where participants know which treatment they are receiving and express their preferences related to that treatment. This evaluation helps to understand the preferences of patients regarding different therapeutic options.
Sponsors or manufacturers of clinical trials, particularly when assessing patient preferences regarding treatment options, are required to file an open-label preference evaluation.
To fill out an open-label preference evaluation, one must complete the evaluation form by providing information about the study, the treatment options, and the participants' stated preferences. Detailed instructions often accompany the form to ensure proper filing.
The purpose of an open-label preference evaluation is to gain insights into patients' preferences and experiences related to a particular treatment, which can help inform clinical decision-making and improve patient-centered care.
An open-label preference evaluation must report information such as the demographics of study participants, the treatment options being evaluated, the methodology used for preference assessment, and the results indicating participant preferences.
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