About PROINSIGHT™

Objectives

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.

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 (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):

• FDA Clinical/Antimicrobial Guidance
• FDA Clinical/Medical Guidance
• EMA Clinical Efficacy and Safety Guidelines
• Health Canada Guidelines
• NICE Clinical Guidelines

Results Display

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:

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

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:

Targeted Patient Population

For each Technology targeted, the following can be retrieved:

• Population inclusion criteria
• General consideration on efficacy/study design
• Statistical considerations
• Guidelines for the presentation of the results

For each concept of interest:

• Endpoint positioning and definition
• Type of Outcome Assessment (OA)
• Name of the COA instrument if stated
• Type of measure recommended (VAS, NRS, Questionnaire, other, etc)
• Rating: for each concept of interest (excluding those representing either biomarkers or survival), a rating provided by our researchers is assigned according to the following categories: 
  • A. The COA instrument is specifically identified and is publicly (not necessarily freely) available with documented measurement properties in the recommended context of use
  • B. The COA instrument is specifically identified, is publicly available, but documented measurement properties are NOT available in the recommended context of use
  • C. Thespecific 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. The COA instrument is recommended but no concept of interest was identified
• Guidance quotation

Safety

Safety recommendations will also be included if available.

Related Guidances

In this tab, any guidances published by other regulatory bodies and for the same indication can be retrieved.