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

John March, Helena C. Kraemer, Madhukar Trivedi, John Csernansky, John Davis, Terence A. Ketter, Ira D. Glick

Research output: Contribution to journalReview articlepeer-review

20 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)2491-2501
Number of pages11
JournalNeuropsychopharmacology
Volume35
Issue number13
DOIs
StatePublished - Dec 2010

Keywords

  • clinical pharmacology/clinical trials
  • depression
  • drug discovery/development
  • mood disorder
  • pragmatic design
  • psychopharmacology
  • schizophrenia/antipsychotics
  • unipolar/bipolar

ASJC Scopus subject areas

  • Pharmacology
  • Psychiatry and Mental health

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