CDER Suggests Schizophrenia Trials Can be Shorter, Simpler
A study from the FDA’s Center for Drug Evaluation and Research (CDER) suggests schizophrenia drug trials can be shorter and include simpler tools for measuring disease severity and treatment response, all without compromising the strength of the outcomes data.
The CDER study was an analysis of pooled data from 32 trials of approved schizophrenia drugs that included more than 14,000 patients. The CDER researchers found that success rates at four weeks, defined as a significant improvement in the overall disease-measurement Positive and Negative Syndrome Scale (PANSS) score, was similar to success rates at six weeks.
This finding indicates that shorter four-week trials may be just as informative as longer six-week trials. Shorter trials may also reduce patient dropout rates, the researchers noted.