[Clinical trial or ″regular clinical practice″? The trasmetir study example]

The methodological and ethical analysis of clinical studies is a responsibility of the Research Ethics Committees. There are scenarios in which this assessment can be very difficult. This is the case with the TRASMETIR trial that studies liver transplantation in patients with unresectable metastases of colorectal carcinoma. It was conducted in several Spanish hospitals as a clinical trial because liver transplantation was not previously considered a treatment indication for these patients. To justify and supervise the trial, it was stated that it would not represent an additional financial burden for the hospitals and that it was a study based on routine clinical practice. Thus, the infrastructure and professionals dedicated to performing liver transplantation for approved indications could participate in this prospective clinical trial as if it were part of their ordinary work. Upon a detailed analysis of this new and interesting experience, we observed that there are ethical issues that require closer attention. These include the distinction between clinical practice and clinical studies, the impact of possible public sponsorship in clinical trials, the information received in order to participate in a trial by the different professional profiles that collaborate in the systematics of each transplant, the priority and availability of biological resources such as organs for transplantation for their integration into clinical trials, or the way in which information is given and the content of this information to the donor or relatives.