After gathering positive preclinical data and submitting a successful Investigational New Drug (IND) application, a phase I clinical trial must be completed to begin bringing a new cancer therapy to the clinic. Phase I clinical trials are conducted to determine the safety of a new therapy and therefore, must be highly regulated and monitored. While phase I trials typically have a smaller patient population and patients may receive an exploratory dose or an escalating dose, the safety data collected in these trials acts as the foundation for the next phase of trials.
This white paper will cover:
- CRO Selection
- Regulatory Considerations
- Planning for Recruitment
- Importance of Protocol Design
