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 strategy, Mapi Research Trust has created this new database to inform about recommendations that are characterized in terms of COAs.
PROINSIGHT™ database is an option of PROLABELS™ database.
The focus of the database is on drug development exclusively. 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: 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 with 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:
A. A COA instrument is specifically identified and is publicly (not necessarily freely) available with documented measurement properties in the recommended context of use
B. A COA instrument is specifically identified, is publicly available, but documented measurement properties are NOT available in the recommended context of use
C. A specific type of instrument (e.g. a visual analog scale) is recommended, but no specific COA instrument is recommended;
D. No COA instrument recommendations appear for this concept of interest
E. A COA instrument is recommended but no concept of interest was identified
Safety recommendations will also be included if available.
In this tab, guidances published by other regulatory bodies and for the same indication can be retrieved if any.