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 2016 to inform users about recommendations that are characterized in terms of COAs.
The PROINSIGHT™ database is an option of the PROLABELS™ database.
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 (cf. Glossary).
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 (cf. Glossary).
The database includes all published guidelines from the following categories (without time restriction):
Once COA recommendations are identified from the source documents, the corresponding guidance is fully described and accessible in PROINSIGHT™.
The following information can be retrieved according to its availability in the source document:
As recommendations are provided according to a given population, each time a specific population is targeted in the source document, a new tab entitled Targeted Patient Population is added to the guidance description:
For each Technology targeted, the following can be retrieved:
For each concept of interest:
Safety recommendations will also be included if available.
In this tab, any guidances published by other regulatory bodies and for the same indication can be retrieved.