Stopping a medical research project for financial reasons.

Letters Stopping a medical research project for financial reasons Sir, We are writing to provide some clarifications on the Editorial Comment by Druëke et al. [1]. We would have been happy to provide these very same clarifications had we been fairly invited to do so before the publication of the article. First of all, we would like to underline that cancelling a clinical trial is always a difficult and costly decision for any pharmaceutical company, for many reasons. In the case of the clinical trial mentioned in Druëke et al. [1], we acknowledge and are convinced that there are several indications of possible benefits of NAC in ESRD patients. The trial we stopped was only a preliminary exploratory study to be followed by larger pivotal clinical trials with hard clinical end points, as required by Regulatory Authorities. After a thorough re-examination of the clinical development plan, Zambon considered that the regulatory constraints it faced were too demanding in terms of the development time of the new use indication. This was the critical reason that led Zambon to the unpleasant decision to suspend the trial, as clearly explained in the letter sent to the participating investigators. In reference to the comment by Druëke et al. [1] about the implications of interrupting a clinical trial, Zambon took special care to ensure that the trial was stopped before any patient had received the study medication, thus avoiding possible harm to the patient's health condition or to his/her expectations. In this regard, we wish to point out that the status of the trial, at the time it was interrupted, was as follows. (i) Only part of the study sites had received approval from the Ethics Committee. (ii) Only 3 out of 40 study sites had received the initiation visit, thus being officially authorized to start enrolling patients. (iii) The study drug had not yet been distributed to any of the study sites. (iv) Only three patients in a single study site had signed the informed consent, but no one of them had undergone any study procedure. Accordingly, in our opinion, no infringement of any conduct was perpetrated. Furthermore, all the participating investigators were promptly informed of the decision through a letter distributed by Zambon, where the reasons for suspending the trial were provided. In conclusion, Zambon believes that all the actions required to interrupt the trial were performed in the most correct way, although …