What have we learned about trial design from NIMH-funded pragmatic trials?


Journal Article

At the 2008 annual meeting of the American College of Neuropsychopharmacology (ACNP), a symposium was devoted to the following question: 'what have we learned about the design of pragmatic clinical trials (PCTs) from the recent costly long-term, large-scale trials of psychiatric treatments?' in order to inform the design of future trials. In all, 10 recommendations were generated placing emphasis on (1) appropriate conduct of pragmatic trials; (2) clinical, rather than, merely statistical significance; (3) sampling from the population clinicians are called upon to treat; (4) clinical outcomes of patients, rather than, on outcome measures; (5) use of stratification, controlling, or adjusting when necessary and not otherwise; (6) appropriate consideration of site differences in multisite studies; (7) encouragement of 'post hoc' exploration to generate (not test) hypotheses; (8) precise articulation of the treatment strategy to be tested and use of the corresponding appropriate design; (9) expanded opportunity for training of researchers and reviewers in RCT principles; and (10) greater emphasis on data sharing.

Full Text

Cited Authors

  • March, J; Kraemer, HC; Trivedi, M; Csernansky, J; Davis, J; Ketter, TA; Glick, ID

Published Date

  • December 2010

Published In

Volume / Issue

  • 35 / 13

Start / End Page

  • 2491 - 2501

PubMed ID

  • 20736990

Pubmed Central ID

  • 20736990

Electronic International Standard Serial Number (EISSN)

  • 1740-634X

International Standard Serial Number (ISSN)

  • 0893-133X

Digital Object Identifier (DOI)

  • 10.1038/npp.2010.115


  • eng