National Institute on Drug Abuse 11257679

Creation and Validation of the Dose-Opioid-Source Evaluation tool (DOSE) - a Robust Opioid Use Clinical Outcome Assessment for Qualification as an FDA Medical Device Development Tool (MDDT)

NIH/NIDA awarded approximately $347,237 to develop and validate the DOSE tool, a clinical outcome assessment for opioid use, aiming for FDA qualification as a Medical Device Development Tool. The project runs from September 2023 to December 2026 and includes multiple validation phases.

Description

The project aims to develop a clinical outcome assessment (COA) for opioid use, qualifying it as an FDA Medical Device Development Tool. The project is funded by NIH/NIDA and involves validation and qualification of the DOSE tool. The project duration is from September 2023 to December 2026. The project involves multiple phases including FDA confirmation, content mapping, usability testing, and validation. The project emphasizes interoperability with existing clinical trial data collection software and aims to support regulatory approval for opioid-sparing interventions.

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