title: What have we learned about trial design from NIMH-funded pragmatic trials?
abstract: 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.
authors.affiliation: Division of Neurosciences Medicine, Clinical Research Institute, Duke University, Durham, NC, USA.
authors.forename: John
authors.initials: J
authors.lastname: March
authors.forename: Helena C
authors.initials: HC
authors.lastname: Kraemer
authors.forename: Madhukar
authors.initials: M
authors.lastname: Trivedi
authors.forename: John
authors.initials: J
authors.lastname: Csernansky
authors.forename: John
authors.initials: J
authors.lastname: Davis
authors.forename: Terence A
authors.initials: TA
authors.lastname: Ketter
authors.forename: Ira D
authors.initials: ID
authors.lastname: Glick
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D009315:National Institute of Mental Health (U.S.); D012107:Research Design; D012109:Research Support as Topic; D014481:United States