Antibody–drug conjugates or ADCs are a burgeoning class of targeted therapies designed to deliver dual therapies in a single, cancer cell-killing package. Targeted therapies are unique in that they have the ability to attack cancer cells while leaving the surrounding, healthy cells, alone. This strategy is expected to result in more effective treatments for cancer – and potentially for other diseases – with fewer toxic side effects than traditional chemotherapies. [1]

The development of targeted therapies has implications for clinical trial design. A two-day course dedicated to educating the next generation of oncologists about the essentials of clinical trial design, implementation, and analysis, organized by the European Society for Medical Oncology (ESMO), addressed 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.

Clinical applicability of a biological idea
“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,” explained 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,” noted 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.

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Targeted therapies
Zielinski noted that 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 examined the principle of clinical trial design from phase I to phase III, 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 was 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 said.

A debate examined the different perspectives of investigators and sponsors. The source also addressed 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”, Zielinski explained.

Understanding regulations
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). This module includes 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 were called upon to give a presentation on design of potential clinical trials, with subsequent discussion with their peers.

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