The development of improved cancer therapy remains a slow, inefficient and risky process, despite the remarkable ongoing advances in our understanding of cancer biology as well as improvements in the industry’s ability to create novel biologically-targeted novel therapeutic agents. This situation will continue until our concept of clinical therapeutics development evolves into a more complete set of biological characterizations of individual patient’s relevant tumor biology with the measured effects of particular therapies on that biology, linked with clinical outcome. Only with this manner of approach, which requires fundamental changes in how clinical trials are designed, resourced, executed, and analyzed, will we learn incrementally more from each patient studied in each trial.

The increased information obtained per patient allows for changed study designs and should result in more efficient focused therapeutics development and drug approvals based on greater clinical activity of drugs in biologically appropriate patients, with improved therapeutic index. Recent examples of the benefits of such an approach and the perils of not proceeding in this manner will be reviewed.

The implications of this new “personalized” approach on malignancy classification, therapeutics development strategy, academic and industry approaches to the organization, resourcing, and conduct of clinical research, together with regulatory and reimbursements, will be considered. The promise of this new approach, where strategic intent transcends classical “translational medicine” activities, promises the more rapid development of agents more predictably effective in patients with cancer.

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