Randomized adjuvant trials in oncology: a necessity or time-consuming luxury?

Excerpt

The question of whether randomized adjuvant trials in oncology are a necessity or a time-consuming luxury addresses one of the most complex aspects of human research and its clinical applications within public health. Randomized trials are an absolute necessity; they have resulted in hundreds of thousands of lives worldwide being saved in the decades since their inception. However, the present system of clinical trials based on an infrastructure devised over 40 years ago cannot now easily handle the rising challenges related to so many new developments occurring simultaneously. Human genome information, molecular classification and techniques enabling the design of new agents based on tumor genetic characteristics will potentially result in the explosive development of new agents or diagnostic classifiers that would accelerate the decline in mortality, especially from breast cancer. At present, however, all these require testing within the existing clinical trial infrastructure. Under the present system, excessive delays are inevitable, unless reforms are implemented that will dramatically accelerate the present process of 'bench to clinic'. …