FDA Law Blog - CDER Launches ClinicalOutcomes Assessment Compendium,Seeks Input on Future Expansions |
Posted: 13 Jan 2016 01:22 AM PST
By James E. Valentine –
On January 13, 2015, CDER’s Clinical Outcome Assessments Staff (formerly Study Endpoints and Labeling Development (SEALD)) announced the launch of Stage 1, or the pilot stage, of its Clinical Outcomes Assessment (COA) Compendium. A COA measures patients’ symptoms, overall mental state, or the effects of a disease or condition on how the patients function. There are four types of COA measures:
The COA Compendium also compliments FDA’s efforts to foster patient-focused drug development (see our coverage of these efforts here). CDER intends for the compendium to facilitate the use of measures that capture outcomes that are important to patients (e.g., PROs) – a “high priority for FDA.” In addition, CDER previously indicated its interest in a second stage of the compendium that would directly incorporate input from Patient-Focused Drug Development meetings to identify gaps in available measurements. Specifically, a list of could be generated of concepts highlighted as important by patients, but for which no tool exists. CDER is seeking input on the utility of the pilot compendium and approaches for future iterations, including any suggested expansions of its scope. Comments can be submitted to FDA’s docket here. |
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