List the different phases of clinical trials involved in the investigation of a novel therapeutic agent in cancer management (3 marks). Explain the meaning of and the rationale for each of these different phases (12 marks). Choose a solid organ cancer. Review the literature on ONE new or relatively new drug that is used (or currently being investigated) in the management of this cancer. Briefly summarise the results of the drug studies in each phase (maximum of 2 studies for each phase). If relevant data/evidence is absent, briefly explain the study design and methodology (using the PICO format) of the studies that need to be done before adoption of the drug in clinical practice (10 marks). Note: You could choose a very new drug that has only been studied in early phase trials, summarise the data that is available and briefly describe how you will proceed with the next phase(s) before it can be widely used.