The Child and Adolescent Psychiatry Trials Network (CAPTN): Lessons learned in the course of infrastructure development

Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.
Child and Adolescent Psychiatry and Mental Health 04/2009; 3(1):12. DOI: 10.1186/1753-2000-3-12
Source: PubMed


In 2003, the National Institute of Mental Health funded the Child and Adolescent Psychiatry Trials Network (CAPTN) under the Advanced Center for Services and Intervention Research (ACSIR) mechanism. At the time, CAPTN was believed to be both a highly innovative undertaking and a highly speculative one. One reviewer even suggested that CAPTN was "unlikely to succeed, but would be a valuable learning experience for the field."
To describe valuable lessons learned in building a clinical research network in pediatric psychiatry, including innovations intended to decrease barriers to research participation.
The CAPTN Team has completed construction of the CAPTN network infrastructure, conducted a large, multi-center psychometric study of a novel adverse event reporting tool, and initiated a large antidepressant safety registry and linked pharmacogenomic study focused on severe adverse events. Specific challenges overcome included establishing structures for network organization and governance; recruiting over 150 active CAPTN participants and 15 child psychiatry training programs; developing and implementing procedures for site contracts, regulatory compliance, indemnification and malpractice coverage, human subjects protection training and IRB approval; and constructing an innovative electronic casa report form (eCRF) running on a web-based electronic data capture system; and, finally, establishing procedures for audit trail oversight requirements put forward by, among others, the Food and Drug Administration (FDA).
Given stable funding for network construction and maintenance, our experience demonstrates that judicious use of web-based technologies for profiling investigators, investigator training, and capturing clinical trials data, when coupled to innovative approaches to network governance, data management and site management, can reduce the costs and burden and improve the feasibility of incorporating clinical research into routine clinical practice. Having successfully achieved its initial aim of constructing a network infrastructure, CAPTN is now a capable platform for large safety registries, pharmacogenetic studies, and randomized practical clinical trials in pediatric psychiatry.

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    • "In recent years, several networks across the world have been created to routinely assess the safety of psychotropic medications in youth (Ronsley et al. 2012; Seida et al. 2012). The Child and Adolescent Psychiatry Trials Network (CAPTN) was created to collect " real life " data of pediatric patients treated with antidepressants drugs in the US (March et al. 2004; Shapiro et al. 2009). In Canada, the Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics in Children (CAMESA) has actively collected data on the safety of antipsychotics in youth (Pringsheim et al. 2011; Ho et al. 2011). "
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