Preface – Part 1

Nik Zeps PhD, St. John of God Health Care Subiaco Hospital, Subiaco, Australia

Nik Zeps PhD, St. John of God Health Care Subiaco Hospital, Subiaco, Australia

In this special issue related to biomarkers and ethics in oncology trials, international experts have provided their perspectives on the most important elements related to their successful design, conduct and implementation of their results into clinical practice.

Dr. Silvia Novello and myself review how there has been a renewed optimism in achieving major improvements in the clinical care of patients based upon the identification and use of biomarkers that relate to the underlying biology of cancer. However, the identification and use of such biomarkers requires that a series of steps be followed to ensure that they are valid and useful. Negotiating the regulatory pathways is not always easy, and both the novice and more experienced clinical researchers are guided through the necessary steps in this overview.

Undertaking human research goes hand in hand with ensuring that people are respected and protected from unnecessary and avoidable risk of harm. The benefits should in all instances over-ride the harms, but in cancer where patients are often at high risk of death and are dependent on care, the balance is sometimes harder to strike, and patients are willing to take risks that they may not in other medical settings. In my article on ethical considerations, I steer a path through the issues that will confront those engaged in biomarker-driven oncology trials and provide a practical approach to ensuring that the highest ethical standards are met without creating unnecessary burdens or hurdles to undertake potentially life-saving research.

We commend this paper to you and hope that it provides a succinct, useful and entertaining guide to undertaking research in this exciting area.