As an academic research Organisation, the EORTC is dedicated to strong principles of independence and scientific relevance.
All studies conducted by the EORTC are reviewed and approved by a panel of independent experts: the Protocol Review Committee. Databases are managed by EORTC Headquarters (HQ) staff, and EORTC controls access to biological material and data 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 public health questions that are in the direct interest of patient management and critical to inform society. These trials are usually supported by charitable or public sources.
Investigator initiated trials (Educational Grant) aim to answer questions geared toward optimising the integration of relatively new treatments into therapeutic strategies within the initial label but also extending beyond the label such as for rare tumours. These trials can be partially or fully supported by industry, in the form of providing the trial drug(s) or financial compensation to the sites. They can also be supported by mixed sources of funding.
Registration trials are fully supported trials aiming at delivering datasets for regulatory purposes. These trials are conducted in close collaboration with pharmaceutical or commercial organisations, while maintaining EORTC’s principles of independence.
Studies are presented by the EORTC Groups and Task Forces. Studies are developed according to the priorities of the scientific strategy as defined by the Scientific Chairs Council. Studies will be developed and optimised in cooperation with the EORTC Headquarters before they can be submitted to the Protocol Review Committee (PRC). The PRC will review study outline proposals in light of the scientific strategy. Granted studies will then be worked out through the EORTC Headquarters for their further development, feasibility, and conduct.
Protection of patients
All EORTC protocols are written and followed in accordance with international standards for ethics: the Declaration of Helsinki, Good Clinical Practice guidelines approved by the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). EORTC activities are performed in line with all international and national regulatory and legal requirements.
EORTC is the legal sponsor for the majority of the trials conducted under its auspices, except in specific territories such as (but not limited to) 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 considering applicable legislation.
For registration trials fully supported by an industrial partner, the industrial partner is 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 access to primary endpoint data is controlled by EORTC.
- 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 Policy defines the conditions for biological material storage and use.
Publication of results
The results of all EORTC studies are published irrespective of outcome (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 reflected in EORTC Policies.
EORTC’s UK registered charity Friends of EORTC is a member of the Association of Medical Research Charities (AMRC), and therefore abides by their conditions of membership. All AMRC members support the AMRC position statement on the use of animals in research and on supporting research in universities.