-
250+
Regulatory guidelines on COAs
Why use PROINSIGHT™ ?
-
Access guidelines on the development of drugs, drug treatments, and methods for economic evaluation
-
Check the concepts and COAs that should be considered to assess a disease’s impact on patients’ life
-
Capture regulatory COA requirements in clinical settings
What information can you find in 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. Any COA endpoint mentioned in a guidance is detailed and characterized in PROINSIGHT™, whatever the method of measure may be: PRO, ClinRO, ObsRO, PerfO.
Guidance sources
-
Drug approval regulatory agencies (FDA, EMA, Health Canada, NMPA China)
-
Health technology assessment agencies (CADTH, EunetHTA)
-
Healthcare stakeholders’ boards (IQWIG, NICE)
Content provided in PROINSIGHT™
- 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
- Target population: for each targeted technology and for each concept of interest
- Efficacy/study design, statistics and results presentation considerations
- COA endpoint information: positioning, type of COA, COA name if stated, recommended type of measure and level of COA recommendation
- 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
The PROINSIGHT™ database is an additional option to the PROLABELS™ database. To learn more, visit ePROVIDE™
One platform, three interconnected databases, the ultimate solution to select fit-for-purpose COAs.
By integrating three layers of information on COAs (COA description, label claims and regulatory guidelines) into one centralized platform ePROVIDE™, we aim at streamlining the COA selection process.
Find out more, visit our other databases' webpages.