By Krista Armstrong, Ph.D. | Senior Vice President, Clinical Development Services & Global Head of Neuroscience
Ensuring that psychiatric clinical trial data accurately captures a compound's safety and efficacy potential requires that sponsors account for the challenges inherent in working with a mentally ill population. Mental illness and its manifestations are almost as varied as the spectrum of human behavior. Understanding the interactions among the myriad genetic, biological, social, and environmental factors that give rise to mental illness is a complex task, which makes clinical trials involving psychiatry drugs quite a challenge.
Observing changes in the disease under study is, in part, a subjective process, and that subjectivity creates risk of undue influence that the patient and/or investigator may not recognize. To further complicate matters, not all symptomatic improvement in mental disorders can necessarily be tied to the product under investigation. Some changes may result from unrelated factors whose therapeutic effect erodes the efficacy signal of a potential treatment.
In this white paper, we explore a range of factors that, if identified and mitigated early in the development process, can maximize the potential for conclusive study results in psychiatric clinical trials.