Surrogate end points in women's health research: science, protoscience, and pseudoscience

Area of Science:

• Biomedical research
• Clinical trials
• Medical ethics

Background:

• Surrogate end points act as proxies for definitive clinical outcomes like death or disease progression.
• Their use in clinical trials aims to accelerate drug development and evaluation.
• However, the validity and reliability of these surrogate markers are critical.

Discussion:

• The adoption of unvalidated surrogate end points, especially in cardiovascular medicine, has been linked to severe patient harm.
• This practice represents a breach of the ethical principle of beneficence, which mandates acting in the patient's best interest.
• Thousands of patient deaths have been attributed to the premature reliance on inadequately validated surrogate markers.

Key Insights:

• Surrogate end points require rigorous validation to ensure they accurately predict clinical benefit.
• Lack of validation can lead to the approval of ineffective or harmful treatments.
• Ethical oversight is paramount in the design and interpretation of clinical trials using surrogate end points.

Outlook:

• Future research must prioritize the development and validation of robust surrogate end points.
• Stricter regulatory guidelines are needed to govern the use of surrogate markers in drug approval.
• Emphasizing patient safety and ethical considerations should guide the future of clinical trial design.