The clinical development of the somatostatin analoque octreotide

The thesis begins with an encapsulated history of the discovery of somatostatin and the launching of the somatostatin analogue program (Chapter II). This is followed by a brief description of the design and preclinical development of octreotide and the original conception of the Clinical Development Program, including Phase I to Phase IV, beginning with the emergence of octreotide in 1982. The underlying motives for using octreotide as a clinical agent are highlighted, which involves tracing briefly the physiological actions of somatostatin, in addition to explaining the pathological basis of the diseases chosen for treatment. Furthermore, the rationales involved in the design of the Clinical Development Program are discussed, as are the decisions underlying the specific clinical goals pursued. This provides an insight into the expectations held at the early stages of development, and relates these hopes to the final results. Where insurmountable problems were enco~tered, the effects of these problems on the progression of research into specific. therapeutic goals are outlined. Our approach to the prioritisation and sequencing of research goals changed as the program progressed. This was due to the impact of new external research findings and the results gained from the trials related to the Clinical Development Program. In reality the Clinical Development Program for octreotide followed a process of evolution and adaptation, rather than sequential steps.