Independent Clinical Cancer Research in the Continuum of Drug Development into Access – for Patient-Centred Cancer Treatment & Care

Access to innovative cancer therapies is hampered by limited clinically relevant information on high expenditure technologies not always reflecting the actual health benefit. Once a drug or technology is on the market, many questions indeed remain. Information on e.g., optimal combination of drugs/treatments, optimal dose, duration and schedule, biomarker determination, and ultimate beneficiary populations, is usually not available at the time of product registration.

Such questions can only be addressed through treatment optimisation research, which includes de-escalation approaches that are long needed as patients may often be over-treated with expensive treatments where accessible, while lack of information prevents access elsewhere – leading to inequalities across the EU. These multi-faceted challenges fall in the gap between supranational approval and long overdue for change national healthcare systems.

‘Treatment optimisation research performed by the non-commercial sector is key to address patient-centred questions in the healthcare systems’, says Dr Denis Lacombe, EORTC CEO. ‘Structuring the role of independent clinical research for treatment optimisation in Europe can contribute to ensure this critically needed continuum.’

EORTC is being very active on policy awareness, demonstrating the importance of independent clinical research for treatment optimisation and improved access in cancer care.

Advocating for structuring the role of independent clinical cancer research as part of a development-to-access continuum

EORTC is taking the opportunity of the French EU Council Presidency to actively contribute to the European Meetings organised by the French ‘Institut National du Cancer’ on February 3-4. In the context of these meetings, EORTC has joined two workstreams on i) Cancer of Poor Prognosis – where it positions SPECTA as an infrastructure enabling access to patients and biological material to understand the biology of cancer, and ii) International Collaboration – where it develops the concept of treatment optimisation as outlined above. EORTC will also lead a masterclass at the event on these topics, coordinated by a journalist. Finally, EORTC will benefit from a stand as part of the event’s exhibition, to further support these communications.

In addition, and as announced by Dr E. Cooke, EMA Executive Director, at the European Cancer Summit in November 2021, as of this year EORTC will co-lead with EMA the newly created academia-led Cancer Medicine Forum. The objectives of the Forum are to leverage the focus given to drug regulation in order to support treatment optimisation, to identify and prioritise research questions for treatment optimisation of approved cancer medicines, as well as to identify other priorities on policy aspects emerging from the academic community. It will help addressing the remaining uncertainties from a clinical perspective, decide on which study(ies) would be needed to address these, and fill the gap within healthcare systems.

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