Operating Principles

As an academic research organisation, the EORTC is dedicated to strong principles of independence and scientific relevance.

All studies conducted by EORTC are reviewed and approved by a Board-appointed panel of independent experts, the Protocol Review Committee. Databases are managed by EORTC headquarters (HQ) staff, and EORTC controls access to biological material collected during each trial. EORTC HQ specialists manage the analysis of study endpoints and publication of primary results, unless it is an “intergroup” clinical trial and another independent research group takes the lead.

There are three types of trials conducted by EORTC

Fully-academic trials answer questions that are not necessarily of direct interest to commercial organisations. These trials are supported by charitable or public sources.

Investigator-initiative trials (Educational Grant) aim to answer questions that are of potential interest to the pharmaceutical industry. These trials are partially supported by this industry, in the form of providing the trial drug(s) or financial compensation to the sites.

Registration trials are fully-supported trials aiming to confirm and safeguard scientific value. These trials are done in close collaboration with pharmaceutical or commercial organisations, while maintaining EORTC’s principles of independence.

Protection of patients

All EORTC protocols are written and followed in accordance with international standards for ethics: the Declaration of HelsinkiGood Clinical Practice guidelines approved by the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)

Trial sponsorship

EORTC is the legal sponsor for the majority of the trials run under its auspices, except in the United States, Canada, and Australia, where trials are performed in collaboration with other partners.

For intergroup trials led by non-EORTC groups, the issue of sponsorship is discussed on a case-by-case basis taking into account applicable legislation. For trials fully supported by an industrial partner, the industrial partner is usually the sponsor.

Regardless of trial sponsorship, EORTC’s principles of independence always apply.

Principle of independence

EORTC Clinical Trials strictly follow the following principles:

  • The study concept is independently approved by the EORTC Protocol Review Committee
  • The study database is managed at the EORTC headquarters or by an equivalent independent academic body, and can only be acquired by the commercial sector after maturity of the primary end-point
  • EORTC is responsible for the primary statistical analysis. A pre-agreed Statistical Analysis Plan (SAP) can be established
  • Study outcomes, regardless of results, shall be published according to EORTC’s publication policy
  • A charter defines the conditions for biological material storage and use

Publication of results

The results of all EORTC studies are published, irrespective of the findings (positive or negative, statistically significant or not), in scientific journals, or presented or disclosed in a manner that fairly reflects the evidence supported by the results. The publications conform to the CONSORT guidelines and to the International Committee of Medical Journal Editors’ guidelines on authorship. (EORTC Policies)