We are writing to provide some clarifications on the Editorial Comment by Drüeke 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 Drüeke 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 Drüeke 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 participat-ing 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 it recognizes the distress that this decision may have caused to the parties involved.
Last but not least, the scientific community must well understand that the pharmaceutical industry has been hit in the last few years, practically in every country, by a wide array of cost-cutting measures that have severely affected margins and, in turn, the possibility of sustaining all preconceived R&D programs. At the same time and with similar scope, registration procedures everywhere are becoming more costly, lengthy and cumbersome. These factors cannot be overlooked since they will continue to generate disappointment in years to come.
Conflict of interest statement. C. Di Padova is currently the Director of the Research and Development Department of Zambon Group.
Zambon Group Spa Milano Italy Email: carlo.dipadova{at}zambongroup.com
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