Terence Ketter

Publication Details

  • What Have We Learned about Trial Design From NIMH-Funded Pragmatic Trials? NEUROPSYCHOPHARMACOLOGY March, J., Kraemer, H. C., Trivedi, M., Csernansky, J., Davis, J., Ketter, T. A., Glick, I. D. 2010; 35 (13): 2491-2501


    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.

    View details for DOI 10.1038/npp.2010.115

    View details for Web of Science ID 000284104400002

    View details for PubMedID 20736990

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