Dear Editor, This letter refers to the paper by J.K. Rybakowski and M. Jarema (Long-term assessment of the efficacy and tolerability of risperidone in early schizophrenia: An international multicenter study, Int J Psych Clin Pract 2004; 8: 147–152).
During the course of monitoring and audit of one of the sites conducting a trial with paliperidone ER in subjects with schizophrenia, serious violations of GCP were found. All ongoing trials were terminated at this site. In addition, a review of previous trials undertaken by this site, including RIS-INT-59, was conducted. Although there was no evidence of violations of GCP in the past at this site, in order to be prudent and cautious, Janssen-Cilag decided to reanalyse the primary efficacy endpoints, after excluding all subjects who participated at this centre. It was also decided that, in order to be transparent, the results of this reanalysis would be conveyed to relevant regulatory authorities and journals.
Thus, the primary efficacy endpoints in the RIS-INT-59 study were reanalysed, this time excluding all subjects (n=20 out of 205) enrolled at the site in question. Therefore, the study included 185 patients, 100 male (54%), and 85 female (46%), aged 15–44 (mean 26±7) years. Paranoid schizophrenia was diagnosed in 104 patients (57%) and schizophreniform disorder in 41 patients (22.5%).
The results of this reanalysis are shown in which should replace Table 1 of that paper. As shown in the table, based on the analysis with and without the site in question, it can be concluded that excluding the data of 20 subjects did not impact the results of the primary efficacy analysis and the conclusions of this study. There was no reanalysis or change of safety findings, as all subjects who participated in the trial were included, as reported in the journal article previously.
Table 1a. The value of PANSS scale before treatment and during last visit – results after excluding 20 subjects.