Conducting clinical research in community mental health settings: Opportunities and challenges

Abstract

Tremendous progress has been made in the past decade surrounding the underlying mechanisms and treatment of neuropsychiatric disease. Technological advancements and a broadened research paradigm have contributed to the understanding of the neurochemistry, brain function and brain circuitry involved in neuropsychiatric disorders. The predominant area of unmet medical need in the United States is major psychiatric disorders, and major depressive disorder is the leading cause of disability for ages 15-44. Total spending on research and development by the pharmaceutical industry has grown exponentially during the past decade, but fewer new molecular entities (NME) for the treatment of major psychiatric disorders have received regulatory approvals compared to other therapeutic areas. Though significant expansion has occurred during the “decade of the brain”, the translation of clinical trials outcomes into the community mental health setting is deficient. Randomized controlled trials (RCTs) have been the standard approach to clinical evaluation of the safety and efficacy of NMEs for the past 60 years; however, there are significant barriers and skepticism in the implementation of evidence-based outcomes into clinical practice. Recruitment of patients, shortages of experienced clinical researchers, regulatory requirements and later translation of outcomes into clinical practice are ever growing problems faced by investigators. The community mental health setting presents particular barriers in the replication of therapeutic outcomes from RCTs. The diagnostic complexity of major psychiatric diseases and the highly selective patient populations involved in clinical trials lend to the gap in translation from the “bench to the bedside”. The community mental health setting lends to a diverse patient population with numerous co-morbidities and environmental factors that are unaccounted in the average RCT. While we acknowledge the enormous complexity in developing novel and innovative treatments for major psychiatric disorders, we must continue to improve the translatability of clinical trials to real world settings. Progress has been rather slow but as the gap in treatment effectiveness is reduced, so will costs and barriers in community mental health.

Keywords: Community mental health; Clinical trials in psychiatry; Study population

Core tip: Development of novel and effective pharmacological agents for the treatment of neuropsychiatric diseases is a long-standing challenge. Despite considerable investments into biomedical research from the pharmaceutical industry, academia and government organizations, the transformation of acquired knowledge from basic science and preclinical areas has been lacking. Randomized controlled trials (RCTs) remains the gold standard in drug development. Over the years, concerns have arisen regarding generalizability of RCT results into routine psychiatric care. Extending RCTs to clinical populations from the community mental health setting will support ecological validity and improve treatment outcomes.