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Percentage increase in the number of approved IDEs (pivotal studies only) with patient reported outcomes (PRO)

Dictionary: CDRH 2016-2017 Strategic Priority: Partner with Patients

Goal: Increase Use and Transparency of Patient Input as Evidence in Our Decision Making

FY 17 Accomplishment: Increased by 75.4 percent the number of approved IDEs (pivotal studies only) with patient reported outcomes (PRO) in support of pre- and postmarket regulatory decisions.

FY 17 Target: By September 30, 2017, increase the number of patient perspective studies (e.g., evaluating patient reported outcomes (PRO) or patient preferences (PPI)) used in support of premarket and postmarket regulatory decisions (compared to FY 2015 baseline).

FY 16 Accomplishment: Increased by 65 percent the number of approved IDEs (pivotal studies only) with patient reported outcomes (PRO) in support of pre- and postmarket regulatory decisions.

Information is current as of December 31, 2017.

Fiscal Year - 2016 to 2017

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TimeTargetPercentage
FY2016N/A65
FY2017N/A75

Number of patient perspective sudies conducted by sponsors in support of pre-and postmarket regulatory decisions

Dictionary: CDRH 2016-2017 Strategic Priorty: Partner with Patients

Goal: Increase Use and Transparency of Patient Input as Evidence in Our Decision Making

FY 17 Accomplishment: Increased to six (from none) the number of patient perspective studies conducted by sponsors in support of pre- and postmarket regulatory decisions.

FY 17 Target: By September 30, 2017, increase the number of patient perspective studies (e.g., evaluating patient reported outcomes (PRO) or patient preferences (PPI)) used in support of premarket and postmarket regulatory decisions (compared to FY 2015 baseline).

FY 16 Accomplishment: Increased to four (from none) the number of patient perspective studies conducted by sponsors in support of pre- and postmarket regulatory decisions.

Fiscal Year - 2016 to 2017

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TimeTargetNumber
FY2016N/A4
FY2017N/A6

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

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