Cost of ADHD clinical trials can be reduced by implementing Quotient ADHD System

BioBehavioral Diagnostics Company announced today that its poster was presented Friday, October 30, 2009 after it was accepted via a rigorous peer-review process and included as a New Research Poster presentation at the Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP) in Honolulu, HI, October 27-November 1, 2009. Calvin R. Sumner, M.D., the company's Chief Medical Officer and Senior Vice President of Clinical Development, presented the study entitled "Does Placebo Response Differ Between Objective and Subjective ADHD Measures?"

Placebo response is a well-known phenomenon in ADHD clinical trials, where subjects report benefit when taking an inactive sugar pill. To achieve registration with the US FDA, drug developers must demonstrate that their product is statistically superior to placebo. Placebo response increases the cost of clinical trials by requiring more subjects or longer observation to accomplish this crucial goal. This pilot study examined the concordance of the Quotient(TM) ADHD Test, an objective assessment tool to measure hyperactivity, inattention and impulsivity, with the current standard of care, clinical ADHD rating scales (ADHD-RS). Rating scales are questionnaires that ask the subject and/or parent about the severity and frequency of ADHD symptoms.

The study indicated that implementing the Quotient(TM) ADHD System for objective measures of symptoms along with a threshold of >40% reduction in symptoms completely eliminated the placebo response. This means that it may be possible to reduce the size and cost of clinical trials for ADHD medications, which ultimately may accelerate data review by the FDA and introduction to the market.