Table 1.

Central Costs for Cancer Treatment Trials

Protocol design and development, including support for meetings and conference calls

Preparation of applications to central regulatory authorities and central ethics authorities, as applicable

Collection/monitoring of institutional and investigator regulatory compliance

Verification of patient eligibility and management of treatment assignment

Clinical trial insurance

Patient random assignment

Database development

Data collection and management

Drug supply and distribution

Statistical design and analysis

Tumor, specimen and imaging banking

Quality assurance/quality control

Onsite monitoring and audits of participating sites

Pharmacovigilance