Assessing patient risk, benefit, and outcomes in drug development: A decade of ramucirumab clinical trials.

Objective: This study aims to evaluate published clinical trials of ramucirumab to assess the risk/benefit profile and burden over time for patients.

Background: The burden of oncologic drug development on patients paired with increasing clinical trial failure rates emphasizes the need for reform of drug development. Identifying and addressing patterns of excess burden can guide policy, ensure evidence-based protections for trial participants, and improve medical decision-making.