Statistics in Oncology Clinical Trials: a learning platform never to miss

With a view to provide a state-of-the-art review or perspectives of statistical issues in oncology clinical trials, Chinese Clinical Oncology is going to inaugurate a special column named “Statistics in Oncology Clinical Trials”. Chaired by Dr. Daniel Sargent and Dr. Qian Shi Department of Biostatistics, Mayo Clinic, Rochester, MN, USA, this special section will publish one or two papers with specific topics quarterly starting at the end of 2013.

The goal of the special section on Statistics in Oncology Clinical Trials is to provide a state-of-the-art review or perspectives of statistical issues in oncology clinical trials, and is expected to convey statistical knowledge which is essential to trial design, conduct, and monitoring to a wide range of researchers in oncology area. Through illustrations of the basic concepts, discussions of current debates and concerns in the literature, and highlights of evolutionary new developments, we are hoping to engage and strengthen the collaborations between statisticians and oncologists for conducting innovative clinical trials. Please follow up and enjoy.

Below are the first few topics to be covered in this special section:

♦Overview: Biostatistician’s role in oncology clinical trials—strive for sound and practical studies;

♦Phase I design: Past, present, and future;

♦Phase II design: History and evolution;

♦Phase III design: Principles;

♦Biomarker-based clinical trial design;

♦Overview of adaptive design;

♦Statistical aspect of translational and correlative studies in clinical trials;

♦Independent data monitoring: The role of the DSMB;

♦Data management and trial quality: From protocol to publication;

♦Issues in clinical trials in rare disease population.

Acknowledgements

Disclosure: The author declares no conflict of interest.