The seminar will mainly focus on critical points related to clinical trials.
Among the others, a critical point is related to the clinical trial endpoints, other than survival, that objectively demonstrate meaningful clinical benefit. In fact, with the introduction of molecular pathology, patients and their oncologists now deal with a greater variety of malignant diseases than ever before, each of which likely benefits from a unique approach to treatment. Furthermore, many new drugs determine slow tumor progression instead of causing tumor shrinkage. Therefore cancer drug trials may require more patients and the more frequent use of placebo controls, thus presenting greater recruitment challenges as well as requiring a long period of time to reach major clinical endpoints, more expensive clinical documentation to record progression events, and additional regulatory scrutiny.
Among the others, a critical point is related to the clinical trial endpoints, other than survival, that objectively demonstrate meaningful clinical benefit. In fact, with the introduction of molecular pathology, patients and their oncologists now deal with a greater variety of malignant diseases than ever before, each of which likely benefits from a unique approach to treatment. Furthermore, many new drugs determine slow tumor progression instead of causing tumor shrinkage. Therefore cancer drug trials may require more patients and the more frequent use of placebo controls, thus presenting greater recruitment challenges as well as requiring a long period of time to reach major clinical endpoints, more expensive clinical documentation to record progression events, and additional regulatory scrutiny.
