The PROINSIGHT™ database centralizes and summarizes published regulatory recommendations concerning the use of Clinical Outcome Assessments (COAs) to determine treatment benefits and to inform on drug approvals and Health Technology Assessment (HTA) reviews.
In order to help sponsors build 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™ subscription.
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 guideline is detailed and characterized, whatever the method of measure: PRO, ClinRO, ObsRO, PerfO. Objective measures such as biomarkers and survival are also listed if at least one COA is mentioned in the guideline.
The PROINSIGHT™ database includes published documents from the following categories (without time restriction):
For the IQWIG, our team of experts review ‘extracts of the final report’ drafted in English by the IQWIG.
Once COA recommendations are identified from the source documents, the corresponding guideline 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 guideline description.
For each targeted technology, the following can be retrieved:
For each concept of interest:
Safety recommendations will also be included if available.
In this tab, any guidelines published by other regulatory bodies and for the same indication can be retrieved.
Our on-going reviews include all new and revised guidelines from the categories cited above.
The oldest guideline is dated 1977.