Based on the unmet clinical needs, it is necessary to seek candidates with potential effects (structural modification, dosage form improvement or brand-new molecules), establish potential applicable diseases and disease populations, and conduct scientific planning and multidisciplinary discussion between the formal planning of clinical trials. The clinical development plan (CDP) is regarded as a map of how to reach the location.

determines the chronology of studies, some of which can be conducted in parallel, identifies major risk areas, and sets key decision points and continue/discontinue criteria.

Creating a CDP involves a team effort, represented by R&D scientists, biostatisticians, project managers, and the marketing department. When making the plan, the team is faced with many choices, such as determining different pathways, different clinical trial designs and endpoints.