Industry

In an era where tumours are being subdivided into new molecular entities, cutting-edge precision medicine is best developed and validated by partnerships between academia and industry. EORTC’s network is optimised for large screening programmes and complex studies aiming to demonstrate the efficacy of new agents, related biomarkers and technologies.

Trials managed by EORTC in partnership with the healthcare industry serve the best interest of patients and respect EORTC’s principles of independence, all the while taking into account the commercial interests and needs of partners.

EORTC has a history of working with the healthcare industry. In the past two decades, we have conducted 17 cooperative studies leading to the registration or extension of registration of new anticancer agents. These studies covered neuro-oncology, breast cancer, melanoma, sarcoma, lung cancer, head & neck cancer and lymphoma.

These partnerships follow two main models:

  • Studies which are performed with a clear commercial intent to register a new anticancer agent, or where the company will require access to the study database
  • Investigator-initiated studies that address public health issues with no commercial objective

Clinical trials conducted with industry partners follow these principles to ensure their neutrality:

  • 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

Flexible aspects of the cooperation revolve around legal sponsorship, pharmacovigilance and on-site monitoring, for instance, and are discussed on a case-by-case basis.

EORTC clinical data base is CFR part 11 and CDISC-compliant to facilitate partnerships with industry.

EORTC works in a fully-transparent way and under strict auditing programmes, at the request of its partners.