A coalition of 29 leading European cancer organisations led by The European Organisation for Research and Treatment of Cancer (EORTC) is urging the EU Institution and policymakers to reform EU-wide drug development.

This is to ensure that ‘Treatment Optimisation’ is incorporated into the development of all new cancer treatments and guarantee a patient-centred approach to improving long-term survival rates. The Treatment Optimisation Manifesto recommendations emphasise that the appropriate use of treatments is essential for optimising patients’ health outcomes and preserving public health and healthcare budgets.

Treatment Optimisation must also take place early, while payers and clinicians should be initiated before the medicine’s full deployment on the market ie as soon as the safety and effectiveness profiles are known, but without delaying patients’ access to innovative treatments.

Speaking about this development, Denis Lacombe, CEO of EORTC, commented: "Novel cancer treatments and technologies have the potential to create a paradigm shift in outcomes for patients living with cancer. However, we must urgently address critical shortcomings in how these new treatments are utilised in real-world conditions by clinical studies.

“There are numerous drugs which have been authorised on the market, with limited knowledge on how to use them for dose, sequence, combination and duration of treatment. Sub-optimal administration of costly treatments may generate unnecessary toxicity for the patients, and negatively impact national healthcare budgets. We need to investigate the optimal way to use new medicines by integrating ‘Treatment Optimisation’.”

This manifesto also highlights that such a regulatory approval-centred clinical research landscape risks neglecting patient-centred issues, including comparative effectiveness of distinct treatment options or long-term safety monitoring.