Timothy A. Yap (editor) - Phase I Oncology Drug Development

The TimesThey Are A-Changin

Bob Dylan

Nobel Laureate for Literature 2016

It is certainly no longer the bad old days in the field of oncology phase I clinical trials.

The days of treating patients with advanced refractory cancer when all prior treatments have failed them with just the next phase I agent coming off the drug development assembly line are thankfully over. Potential new therapeutic entities are becoming available for phase I clinical trials at a rapid clip. Whether we are referring a patient for a possible phase I trial or consenting a patient for a phase I study, we must make sure we are offering our patients the best possible chance they will actually benefit from that new agent.

In the bad old days, only about 1 in every 15 or so new agents tried actually had evidence of helping someone in a phase I trial. Today, it is thankfully at least 1 in every 3 new agents (that will provide clinical benefit for a patient). In fact, with better science, better patient selection, etc., if no participant in a phase I trial derives benefit from the new agent, one quickly wonders whether there is any future at all for that drug. Therefore, now, more than ever, it is critical that physicians trying to do their very best for their oncology patient be familiar with the very latest information on strategies for the most efficient ways to develop a new anticancer agent. Presently, it can make a real difference for patients, e.g., they have a greater chance of achieving clinical benefit in the phase I trial. Done properly, a patients participation in a phase I clinical trial has a much higher likelihood of helping them (30% today versus 3% in the past). Therefore, in this day and age, to do the best for our patients with advanced cancer, our patients should be offered participation in a phase I clinical trial.

In this volume Phase I Oncology Drug Development, three of our most outstanding physician investigators (Timothy Yap, David Hong, and Jordi Rodon) have done all of us a service by assembling a most important perspective on what we all should know about present-day phase I clinical trials.

The authors in this volume cover perspectives from multiple distinguished multinational experts. They, first of all, remind us not to forget the basics like good pharmacokinetic/pharmacodynamic principles and how a great biomarker wins the day for giving our patients the best chance for clinical benefit. They also give the best chance for FDA approval.

Throughout the volume, there are multiple successful and unsuccessful examples of therapeutic development. These are very helpful examples. There are also some incredibly helpful tables and diagrams to emphasize important points.

In summary, this is a must-read volume for all those who want to provide the very best possibilities for their patients with advanced cancer. The editors and authors have given us their very best. Yes, the times in phase I trials, they are a-changin.