Randomized trials are important for assessing the clinical benefits, side effects and survival outcomes of proton therapy in patients but face a number of challenges. This is especially true in the U.S., where the biggest barrier is insurance, with many payers unwilling to cover proton therapy for patients and thereby preventing them from taking part in trials.

Additionally, resistance from various international authorities to reimburse providers for PT has contributed to cost barriers, which in turn has led to demand for new proton therapy systems to be cut in half, according to MEDraysintell’s Proton Therapy World Market Report & Directory. It says that at least 10% of external radiotherapy patients could benefit from proton therapy. This would require some 2,800 particle therapy treatment rooms to be installed worldwide and could help propel demand.

"Proton therapy, like any business in the medical field, is directly affected by reimbursement policies, which differ in each country or region worldwide. Generally, countries that have a proton therapy center have a reimbursement policy for proton therapy implemented by their national health insurance system and/or covered by private insurances,” Paul-Emmanuel Goethals, co-founder of MEDraysintell, told HCB News in March.

Funding for ProtectTrial will be provided by Innovative Medicines Initiative (IMI), EFPIA, IBA and Varian, a Siemens Healthineers company. “We are especially pleased to contribute with AI-driven solutions and cloud-based infrastructure to the consortium,” said Kolleen Kennedy, president of the proton solutions and growth office at Varian.

Also playing a role in the project will be existing networks of the European Particle Therapy Network (EPTN) and the European Society for Radiotherapy and Oncology (ESTRO).

The trial is expected to be completed in 2027.

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