PROINSIGHT™

PROINSIGHT

The aim of the PROINSIGHT database is to centralize and summarize published regulatory recommendations concerning the use of clinical outcome assessments (COAs) issued by the FDA, the EMA, IQWIG, EunetHTA, the NICE, and Health Canada in drug development.
The PROINSIGHT™ database is an option of the PROLABELS™ database and focuses on the same scope: any COA endpoint mentioned in a guidance is detailed and characterized, whatever the method of measure may be: PRO, ClinRO, ObsRO, PerfO.

Content

The following information can be retrieved according to its availability in the source document:

• Guidance description: Health authority (agency which published the guidance) / Date of publication by the regulatory body / Guidance status (draft, final/adopted) / Therapeutic area / Therapeutic indication / Objective of the guidance / Link to the source document
• Targeted patient population: 
  • For each technology targeted, the following can be retrieved: population inclusion criteria / general consideration on efficacy/study design / statistical considerations / guidelines for the presentation of the results
  • For each concept of interest: endpoint positioning and definition / type of Outcome Assessment (OA) / Name of the COA instrument if stated / type of measure recommended (VAS, NRS, Questionnaire, other, etc) / rating: for each concept of interest (excluding those representing either biomarkers or survival) a rating provided by our researchers is assigned​
• Safety recommendations: included if available
• Related guidance: any guidance published by the other regulatory bodies reviewed in the database for the same indication will be indicated

Updates
Our on-going reviews include all new guidance, revisions, and withdrawals with weekly updates throughout the year.

Access
To learn more, visit ePROVIDE