Following the publication of a review of Phase III clinical trials for drugs for schizophrenia by the FDA, which suggested improvements to clinical trial design;

Philippa Salter, Neurology Analyst at GlobalData, a leading data and analytics company, offers her view:

“Altering clinical trial design to increase efficiency and reduce costs may encourage developers to pursue drug development for the schizophrenia market, which could result in more drug approvals in future. Schizophrenia remains a market with significant unmet needs for novel treatments for the negative symptoms and cognitive impairments seen in schizophrenia, options for treatment-resistant patients, drugs that increase compliance rates, and for drugs with improved safety profiles.

“Being able to shorten Phase III trial duration without affecting efficacy and safety results will shorten the length of the drug development process and reduce the cost of the clinical trial, which is an important consideration for drug developers. This will be beneficial for companies with drugs in Phase II development for schizophrenia, including Roche, Merck, and Karuna Therapeutics, when they come to planning and running Phase III trials for those drugs.

“One of the biggest challenges faced by drug developers when running clinical trials in patients with schizophrenia is a high patient dropout rate, which can affect trial results. By being able to run shorter trials, developers should see fewer patient dropouts, which will make trial results easier to interpret.

“By reducing the Positive and Negative Syndrome Scale (PANSS) test from measuring 30 symptoms to just 19, not only will it save time, but it also reduces variability of patient responses making it easier to identify the effects of the drug in the trial. This means that a lower number of participants are required in a trial to demonstrate a significant effect of a drug, which will also help to reduce clinical trial costs.”