(go to content)

Castellano | Euskara | Français | English

 Imagen decorativa
DTB: Vol 32 No 1

Content tools

Share it

  • Meneame
  • Delicious
  • Twitter
  • Google
  • Facebook

Surrogate outcomes and fast-track drug approval

Bol Inf Farmacoter Navar. 2025;32 (1):1-17
https://doi.org/10.54095/BITN20253201EN

 


Surrogate outcomes require adequate validation to prove their usefulness. However, health authorities accept variables with progressively lower standards. Accelerated approvals require confirmatory studies that are often not completed. HIV viral load or blood pressure are examples of adequately validated variables. In contrast, inconsistencies are identified in variables used in the approach to cancer, dementia, osteoporosis and infectious or cardiovascular diseases. Premature access to pharmacological therapies may result in a higher incidence of adverse reactions with little scope for implementing harm mitigation strategies. The abandonment of clinical trials in favour of predictive or observational designs compromises the quality of the evidence obtained.
Enviar comentario

You can send us a comment or suggestion and we will respond to most frequently asked questions

Competing interests (complete this field only if you have competing interests)

 

 

 

 

Suggestions/Comments  

Author:

LUIS CARLOS SAIZ FERNÁNDEZ
Unit of Innovation and Organization
Navarre Health Service, Spain

Government of Navarre

Contact us | Accessibility | Legal notice | Site map