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 language | English (US) |
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Pages (from-to) | 2491-2501 |
Number of pages | 11 |
Journal | Neuropsychopharmacology |
Volume | 35 |
Issue number | 13 |
DOIs | |
State | Published - 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