Clinical research in a peripheral radiotherapy department: a feasibility analysis

The aim of this analysis is to present the methodology used to promote clinical research in a peripheral Italian department of radiotherapy (RT) and the results in terms of scientific output. Internal treatment guidelines were developed, available on the computer network of the department, containing a schematic summary 1–2 pages long of each protocol. Furthermore, a home-made database was designed to be used both as a medical record and for prospective data recording. Data entry was subjected to an “independent check” by a second radiation oncologist. Regular meetings were organized to update all staff on the aim and conduct of the various running trials and to promote the enrollment of patients and the involvement of other specialists in clinical research. In a period of about 11 years: (1) 34 protocols for clinical trials were written and approved; (2) 7463 patients had undergone RT; of these patients, 6321 patients (85 %) were enrolled in clinical trials; (3) 345 papers/book chapters/abstracts were published; of them, 127 papers have been published in journals currently featured on PUBMED; (4) 119 scientific meetings were held. This experience shows that an independent clinical research is possible even in a non-academic and peripheral RT department. In particular, our experience suggests that personnel and resource constraints can be at least partially overcome by a strong personal and group motivation and with the adoption of flexible solutions.