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The child and adolescent psychiatry trials network (CAPTN): infrastructure development and lessons learned.

Publication ,  Journal Article
Shapiro, M; Silva, SG; Compton, S; Chrisman, A; DeVeaugh-Geiss, J; Breland-Noble, A; Kondo, D; Kirchner, J; March, JS
Published in: Child Adolesc Psychiatry Ment Health
March 25, 2009

BACKGROUND: 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." OBJECTIVE: To describe valuable lessons learned in building a clinical research network in pediatric psychiatry, including innovations intended to decrease barriers to research participation. METHODS: 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). CONCLUSION: 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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Published In

Child Adolesc Psychiatry Ment Health

DOI

EISSN

1753-2000

Publication Date

March 25, 2009

Volume

3

Issue

1

Start / End Page

12

Location

England

Related Subject Headings

  • Developmental & Child Psychology
  • 5203 Clinical and health psychology
  • 5202 Biological psychology
  • 5201 Applied and developmental psychology
  • 1701 Psychology
 

Citation

APA
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ICMJE
MLA
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Shapiro, M., Silva, S. G., Compton, S., Chrisman, A., DeVeaugh-Geiss, J., Breland-Noble, A., … March, J. S. (2009). The child and adolescent psychiatry trials network (CAPTN): infrastructure development and lessons learned. Child Adolesc Psychiatry Ment Health, 3(1), 12. https://doi.org/10.1186/1753-2000-3-12
Shapiro, Mark, Susan G. Silva, Scott Compton, Allan Chrisman, Joseph DeVeaugh-Geiss, Alfiee Breland-Noble, Douglas Kondo, Jerry Kirchner, and John S. March. “The child and adolescent psychiatry trials network (CAPTN): infrastructure development and lessons learned.Child Adolesc Psychiatry Ment Health 3, no. 1 (March 25, 2009): 12. https://doi.org/10.1186/1753-2000-3-12.
Shapiro M, Silva SG, Compton S, Chrisman A, DeVeaugh-Geiss J, Breland-Noble A, et al. The child and adolescent psychiatry trials network (CAPTN): infrastructure development and lessons learned. Child Adolesc Psychiatry Ment Health. 2009 Mar 25;3(1):12.
Shapiro, Mark, et al. “The child and adolescent psychiatry trials network (CAPTN): infrastructure development and lessons learned.Child Adolesc Psychiatry Ment Health, vol. 3, no. 1, Mar. 2009, p. 12. Pubmed, doi:10.1186/1753-2000-3-12.
Shapiro M, Silva SG, Compton S, Chrisman A, DeVeaugh-Geiss J, Breland-Noble A, Kondo D, Kirchner J, March JS. The child and adolescent psychiatry trials network (CAPTN): infrastructure development and lessons learned. Child Adolesc Psychiatry Ment Health. 2009 Mar 25;3(1):12.
Journal cover image

Published In

Child Adolesc Psychiatry Ment Health

DOI

EISSN

1753-2000

Publication Date

March 25, 2009

Volume

3

Issue

1

Start / End Page

12

Location

England

Related Subject Headings

  • Developmental & Child Psychology
  • 5203 Clinical and health psychology
  • 5202 Biological psychology
  • 5201 Applied and developmental psychology
  • 1701 Psychology