[Surrogate end point fallacies -- the urge for randomized trials with clinical endpoints]

Area of Science:

• Clinical Medicine
• Preventive Medicine
• Pharmacology

Context:

• Surrogate endpoints are frequently used in clinical trials to assess treatment efficacy.
• This practice is particularly prevalent in preventive medicine and cardiovascular risk factor management.
• Examples include hormone replacement therapy, vitamin supplements, and cardiovascular drugs.

Purpose:

• To critically evaluate the reliability and potential detriments of using surrogate endpoints in medical research and practice.
• To highlight instances where surrogate endpoints have led to misleading conclusions about treatment benefits.
• To examine the implications for both drug and non-drug interventions.

Summary:

• Growing evidence suggests that reliance on surrogate endpoints can be detrimental, leading to the adoption of ineffective or harmful treatments.
• Many oral antidiabetic agents, despite lowering blood glucose (a surrogate endpoint), have been associated with increased morbidity and mortality.
• Non-drug interventions also exhibit surrogate endpoint fallacies, impacting psychological, nursing, educational, and social policy areas.

Impact:

• Underscores the critical need for clinical outcome measures over surrogate markers in evaluating medical interventions.
• Warns against the widespread use of new compounds and interventions lacking robust evidence of clinical benefit.
• Emphasizes the potential for significant patient harm and resource misallocation due to flawed endpoint selection.