Background The hospital has an important national role in the conduct of non-profit clinical trials. These represent 58% of the studies approved in 2012 and about 5% of them involve the use of lenalidomide

Purpose To define the cost savings that conducting non-profit clinical trials could generate for the Hospital and the NHS, focusing on the evaluation of innovative high-cost medicines such as lenalidomide

Materials and methods Five active trials involve the use of lenalidomide. A cost evaluation was conducted on these studies in terms of what it would cost the Hospital, comparing three different scenarios: if the patients were

1. enrolled in a non-profit clinical trial

2. treated off-label with lenalidomide

3. given gold standard treatment

Results

1. It costs the hospital 23,500 € to treat the patients enrolled in the clinical trials considered. Lenalidomide is provided free by the pharmaceutical company.

2. 3,963,409 € is the cost of lenalidomide that the company should claim for the enrolled patients. Such expenditure is supposed to be borne by the regional health system and then the hospital as the use is considered off-label.

3. 2,288,646 € is the average cost of therapeutic alternatives suggested by NHS guidelines. The medicines used most and which would produce this increase in expenditure are thalidomide and bortezomib.

Conclusions The analysis shows that in the first case the expense for patient treatment appears paltry compared to the other two scenarios. This result emphasises the importance of non-profit clinical trials, which may also represent a tool that can reduce the expense of high-cost medicines. This also allows patients to be treated according to innovative regimens, giving them new chances that would be denied had we followed NHS guidelines rigidly.

No conflict of interest.