1. Phase III studies determine standards of care
2. Patient safety and data integrity
3. European Union Clinical Trial Directive: Sponsorship, drug and insurance costs, pharmacovigilance
4. What is the evidence-based benefit to patients after 5 yr of EU Clinical Trial Directives?
5. To publish or perish
6. Vicious circle between rising bureaucracy and costs of trials, the contract research organization boom, and the globalization of trials
7. It's time for a change
Conflicts of interest