Study

Our study was set up to evaluate the potential survival and anti-tumour benefits of using a mammalian target of rapamycin inhibitor (sirolimus) in liver cancer patients who had received transplants.2 The study is an investigator initiated trial in 10 European countries (Austria, Belgium, Finland, France, Germany, Italy, the Netherlands, Spain, Sweden, and the United Kingdom) and three non-EU countries (Australia, Canada, and Norway) with a total of 40 sites in the EU and four sites outside the EU. Regensburg University Hospital is the trial sponsor and thus is responsible for its conduct; this point is a foundation of our trial and we made this clear to all parties involved. Although the manufacturer of the study drug provides funds for the trial, it is not the study sponsor and therefore does not conduct or administer the study, including relations with ethics committees.