Phase III Clinical trials: what methodology?

Design of Phase III Clinical Trials

Phase III and IV clinical trials: what you and your patients need to know.

Note: This column is made possible through an educational grant from CChange, a Washington, DC, based organization comprising the nation’s key cancer leaders from government, business, and nonprofit sectors. These cancer leaders share the vision of a future where cancer is prevented, detected early, and cured or is managed successfully as a chronic illness. The mission of C-Change is to leverag...

Embracing failure: What the Phase III progesterone studies can teach about TBI clinical trials

BACKGROUND Despite positive preclinical studies and two positive Phase II clinical trials, two large Phase III clinical trials of progesterone treatment of acute traumatic brain injury (TBI) recently ended with negative results, so a 100% failure rate continues to plague the field of TBI trials. METHODS This paper reviews and analyses the trial structures and outcomes and discusses the implic...

Update on Current Phase III Clinical Trials in Melanoma

Melanoma is the deadliest form of skin cancer and responsible for 4% of all cancer deaths and 86% of skin cancer-related deaths in the United States (Losina et al., 2007). Melanoma is caused by malignant growth of the melanocytes, which are melanin-producing cells found in the skin’s epidermis, hair, and eyes. In melanoma, these cells undergo an uncontrollable cell growth that manifests in the ...

The future of clinical research beyond phase III trials.

It is well accepted that prospectively designed, randomized, and appropriately powered clinical trials serve as the gold standard for generating medical evidence in support of the efficacy of a treatment. Successful completion of these socalled phase III trials, however, often can be challenging. Two major issues that often are impediments to implementation and/or completion of phase III trials...