The use of surrogate endpoints in regulating medicines for cardio-renal disease: opinions of stakeholders.

ABSTRACT:

Aim

There is discussion whether medicines can be authorized on the market based on evidence from surrogate endpoints. We assessed opinions of different stakeholders on this topic.

Methods

We conducted an online questionnaire that targeted various stakeholder groups (regulatory agencies, pharmaceutical industry, academia, relevant public sector organisations) and medical specialties (cardiology or nephrology vs. other). Participants were enrolled through purposeful sampling. We inquired for conditions under which surrogate endpoints can be used, the validity of various cardio-renal biomarkers and new approaches for biomarker use.

Results

Participants agreed that surrogate endpoints can be used when the surrogate is scientifically valid (5-point Likert response format,

SUBMITTER: Schievink B 

PROVIDER: S-EPMC4182561 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature