Recruitment Model for Decision Making in Innovative Therapies: Application to Carbon Ions and Protons Radiotherapy

Article Outline

• Purpose/Objective(s)
• Materials/Methods
• Results
• Conclusions
• Copyright

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Purpose/Objective(s) 

An original model was developed to simulate the consequences on patients' recruitment in innovative therapy facilities of several scenarios for the expected clinical benefit and the specificities of the demand and the offer. It was applied to carbon ions and protons radiotherapy and tested in the French context: carbon ion radiotherapy facility project and two existing protons facilities, Medicyc (Nice) with indications limited to eye melanoma and the ICPO (Paris) within renovation with an additional gantry.

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Materials/Methods 

The demand consisted on selected indications, each of them associated with a proton and/or a carbon ions therapeutic protocol that are classified in “priority levels” according to the expected benefit and its level of proof compared to alternative standard therapies. Each protocol specified several requirements: gantry versus fixed beams and treatment room immobilization duration. The offer included 4 centers: ICPO, MediCyc and two potential locations for a carbon ion center, Lyon (ETOILE) and/or Caen (Asclepios). Each of the treatment rooms were characterized by their medical and technical equipment and by a treatment time capacity. The impact of the distance for patient recruitment led to the definition of sub-areas with specific geographic attraction towards each centre and in which the incidence of each indication was estimated. Two scenarios for the recruitment area were simulated: one limited to France and one extended to Europe (Table 1). The multi-step allocation process starts with a random draw of a patient in the highest priority levels' protocol, identifies room(s) available, applies if required the geographic attraction factors as to propose a room allocation to the patient, who will finally accept or not to be recruited according the expected benefit and the distance factors.

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Results 

Major quantitative and qualitative consequences were reported. For instance, the increase of high priority indications obtained by the extension to Europe and the equipment of all the rooms with a gantry was also associated to a significant reduction of the total recruitment due to protocols' characteristics. The modification of the expected benefit or attraction values or led to an extension of the indications only in the “France scenario”. The location of the carbon ion centers did not impact the recruitment with only one center, but the simulation of both centers resulted in significant qualitative differences for their respective recruitment.

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Conclusions 

The recruitment model may be an important contribution to support decision making in a context on uncertainties and competition for innovative therapies.

Table 1.