To help sponsors build their endpoint strategies, Mapi Research Trust launched the PROINSIGHT™ database in 2017 as a way to inform users about recommendations characterized in terms of Clinical Outcome Assessments (COAs). This database centralizes and summarizes published regulatory recommendations concerning the use of COAs to determine treatment benefits in drug development and approval. The PROINSIGHT™ database is a supplementary option within the PROLABELS™ subscription.
In some clinical settings, COA strategies should reflect both regulatory and payer perspectives. Therefore, the scope of PROINSIGHT™ was extended to include guidelines that give recommendations on the assessment of health technologies. These guidelines consider effectiveness and safety dimensions, but also costs and economic implications, ethical, social, cultural and legal issues, organizational and environmental aspects.
The landscape of drug approval and pricing reporting is a complex one. Private, non-profit and governmental organizations, each following diverse missions, are releasing reviews and recommendations which can help pharmaceutical industry and researchers to better understand or define their relevant COA strategies in clinical settings.
Drug Approval regulatory agencies:
Health technology assessment agencies:
Healthcare stakeholders’ boards:
Following this review process, the selected guidelines are scanned and the identified concepts (quality of life, symptoms, functioning etc.) and/or COA are described and made accessible through a PROINSIGHT™ subscription. As in PROLABELS ™, objective measures such as biomarkers and survival are listed if at least one COA is mentioned in the guidelines.
For included guidelines, the following information can be accessed according to its availability in the source document:
For each targeted technology, the following can be retrieved:
For each concept of interest:
Safety COA considerations are included if available.
In this tab, any guidelines for the same indication published by other regulatory bodies can be accessed.
The oldest guideline is dated 1977 and the on-going review includes new and revised guidelines, released by the agencies listed above, since then.