CDER Finds Ways to Streamline Schizophrenia Drug Trials

Using pooled data from 32 trials of approved schizophrenia drugs representing over 14,000 patients, CDER researchers from the Office of Clinical Pharmacology and Office of New Drugs say they have identified two ways to make Phase 3 trials of these drugs more efficient, less costly, and potentially more likely to identify new and effective treatments. An online Regulatory Science Impact Story identifies the two suggested approaches as shortening clinical trials from six to four weeks and simplifying the Positive and Negative Symptom Scale (PANSS) used to assess symptom severity during a clinical trial from 32 to 19 items.

The researchers say that combining a shortened PANSS measurement with a four-week trial may be a practical option for designing new trials of drugs to treat schizophrenia. “Shorter duration trials can accelerate drug development in schizophrenia,” they say, “and the modified PANSS can be a more meaningful clinical outcome assessment tool.”