ESMO Press Release: Clinical Trial Design in the Era of Targeted Therapies

A course dedicated to educating the next generation of oncologists about the essentials of clinical trial design, implementation, and analysis, will be organised this week by ESMO (European Society for Medical Oncology).

The two-day course addresses the fundamental aspects of clinical trials, such as the selection of appropriate endpoints, statistics for clinicians, and the use of biomarkers in clinical trials of targeted treatment modalities.

ESMO Clinical Trials Course 2015

“The results of clinical trials represent crucial proof of the clinical applicability of a biological idea, and its translation into the clinical practice via an appropriate drug or a drug combination,” says Professor Christoph Zielinski, Chair of the ESMO Clinical Trials Course.

“One of the most important principles for a successful clinical trial is well-considered and realistic study design, but the development of a good design is a big challenge, especially for young scientists,” says Zielinski, director of the Department of Medicine I of the Medical University of Vienna, head of the Comprehensive Cancer Center Vienna, member of the ESMO Executive Board.

The ESMO Clinical Trial Course was conceived in order to train young oncologists in the complex aspects of clinical trials.

Zielinski says these skills are particularly relevant in this era of targeted therapies for cancer, which demand careful and appropriately designed clinical trials to assess their efficacy.

Aided by the ESMO Faculty from a range of clinical backgrounds, the course will examine the principle of clinical trial design from phase 1 to phase 3, with a particular focus on clinical trials of targeted therapies.

As well as covering endpoint selection, clinical statistics and biomarker identification, attendees will also be involved in discussions about quality of life as a possible endpoint and moveable target in clinical trials.

The course, which will be run at the NH Airport Hotel in Vienna from 27-28 March, is addressed to ESMO members under the age of 45 years.

“The course is intended to attract particularly young oncologists from the ESMO community, to enable them to enter the clinical arena with appropriate schooling and expertise, and develop their careers by the design, implementation, and analysis of clinical trials,” Zielinski says.

A debate will examine the different perspectives of investigators and sponsors, and there will also be a session exploring why doctors should participate in clinical trials.

“Good Clinical practice criteria are of particular intricacy and need to be well understood when clinical trials are being developed”, says Zielinski.

Given the absolute necessity to understand such regulations, ESMO is also launching a module on Good Clinical Practice (GCP) given by the head office of the Central European Cooperative Oncology Group (CECOG).

The module will include sessions on the regulations regarding the role of the different parties involved, to guarantee quality control and to abide by all regulatory measures on the national as well as international level.

“The ESMO module on GCP will enable participants to play a role in the evolving field of clinical trials in oncology”, Zielinski concludes.

Towards the end of the course, participants will be called upon to give a presentation on design of potential clinical trials, with subsequent discussion with their peers.