Methodology of Clinical Trials

In response to the growing disconnect between healthcare costs and clinical benefit, as well as the widening disparities in access to care across European nations, the European Society for Medical Oncology (ESMO) developed the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS).

Clinical trials can be intrinsically slow and high-risk, negatively affecting research for new treatments in challenging areas like oncology where there is a need to make faster progress. These properties are mainly due to methodological aspects. For decades, the conventional procedure of clinical trials has compared a new therapy to the standard of care for a specific disease in a two-arm setting.

Evidence-based medicine is the cornerstone of medical practice, and yet clinicians are rarely offered training in the tricky business of finding, evaluating and making sense of the evidence they need. Anna Rouillard reports on an ESO-Cochrane Masterclass which seeks to fill that gap.

The EORTC New Drug Development Office (NDDO) was established in 1984 and remained active in the field of anticancer drug development for 15 years. Part 1 of our article describes how NDDO was set up under the EORTC umbrella as an infrastructure for drug development; this part describes NDDO’s main achievements during this period.

The EORTC New Drug Development Office (NDDO) was established in 1984 and remained active in the field of anticancer drug development for 15 years. This article provides overviews of new experimental anticancer agents which were investigated in various development phases, including pharmaceutical development, preclinical toxicology, bioassay development, preclinical pharmacokinetics, phase I dose escalation studies and disease-oriented phase II studies.