About PROINSIGHT

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 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

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:

Guidelines Description

• Health authority (agency which published the guideline)
• Date of publication by the regulatory body
• Guideline status (draft, final/adopted)
• Therapeutic area
• Therapeutic indication
• Objective of the guideline
• 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 guideline description.

Targeted Patient Population

For each targeted technology, 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 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 is specifically identified and is publicly (not necessarily freely) available with documented measurement properties in the recommended context of use
  • B. The COA is specifically identified, is publicly available, but documented measurement properties are NOT available in the recommended context of use
  • C. The type of instrument (e.g. a visual analog scale) is recommended, but no specific COA is recommended;
  • D. No COA recommendations appear for this concept of interest
  • E. The COA is recommended but no concept of interest was identified
• Guidance citations

Safety

Safety recommendations will also be included if available.

Related Guidelines

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.