Surrogate endpoints in cancer drug development.

Over the next three years a large number of novel, mechanistically targeted drugs will enter clinical trials for cancer. The remarkable progress in understanding the molecular biology of cancer has provided an enormous range of validated targets for drug discovery. Following lead optimisation and suitable pharmaceutical formulation these compounds have undergone rapid screening in preclinical models. Innovative methods of clinical development are now essential to ensure optimal dose determination and scheduling. The discovery of novel surrogates for efficacy is essential in this fast moving area and requires imaginative partnerships between academic groups and the pharmaceutical industry.