The PROINSIGHT database centralizes and summarizes published regulatory recommendations concerning the use of clinical outcome assessments (COAs) (cf. Glossary) to determine treatment benefit and to inform on drug approval and health technology assessment (HTA) review.
In order to help sponsors define their endpoint strategies, Mapi Research Trust launched this database in to inform users about recommendations that are characterized in terms of COAs.
For the Institute for Quality and Efficiency in Healthcare (IQWIG), our team of experts review ‘extracts of the final report’ drafted in English by the IQWIG without time restriction.
Database Content and Information Sources
The focus of the database is exclusively on drug development. Device guidelines are not included.
The scope of PROINSIGHT™ database is in line with the content of PROLABELS™: any COA endpoint mentioned in a guidance is detailed and characterized, whatever the method of measure may be: PRO, ClinRO, ObsRO, PerfO.
Objective measures such as biomarkers and survival are also included in the database if at least one COA is mentioned in the guidance, but they are not accompanied by detailed descriptions of the measures.
Biomarkers include laboratory tests of blood or other body fluids or tissues, or automated measures of biologic or pathologic processes that do not require human judgment or motivation in the generation of a score, e.g., cardiac monitoring, electroencephalograms, imaging tests that are read by electronic algorithms.
The database includes all published documents from the following categories (without time restriction):
FDA Clinical/Antimicrobial Guidance
FDA Clinical/Medical Guidance
EMA Clinical Efficacy and Safety Guidelines
Health Canada Guidelines
IQWIG Systematic Reviews of Guidelines
NICE Clinical Guidelines