Am J Psychiatry 162:836-846, May 2005
© 2005 American Psychiatric Association
The Case for Practical Clinical Trials in Psychiatry
John S. March, M.D., M.P.H.,
Susan G. Silva, Ph.D.,
Scott Compton, Ph.D.,
Mark Shapiro, M.A.,
Robert Califf, M.D., and
Ranga Krishnan, M.D.
OBJECTIVE: Clinical trials in psychiatry frequently fail to maximize clinical utility for practicing clinicians, or, stated differently, available evidence is not perceived by clinicians (and other decision makers) as sufficiently relevant to clinical practice, thereby diluting its impact. To attain maximum clinical relevance and acceptability, researchers must conduct clinical trials designed to meet the needs of clinicians and others who are making decisions about patients’ care. The authors present the case for psychiatry’s adoption of the practical clinical trials model, which is widely used in research in other areas of medicine. METHOD: The authors outline the characteristics and scope of practical clinical trials, give examples of practical clinical trials, and discuss the challenges of using the practical clinical trials model in psychiatry, including issues of funding. RESULTS: Practical clinical trials, which are intended to provide generalizable answers to important clinical questions without bias, are characterized by eight key features: a straightforward clinically relevant question, a representative sample of patients and practice settings, sufficient power to identify modest clinically relevant effects, randomization to protect against bias, clinical uncertainty regarding the outcome of treatment at the patient level, assessment and treatment protocols that enact best clinical practices, simple and clinically relevant outcomes, and limited subject and investigator burden. CONCLUSIONS: To implement the practical clinical trials model in psychiatry will require stable funding for network construction and maintenance plus methodological innovation in governance and trial selection, assessment, treatment, data management, site management, and data analytic procedures.
This article has been cited by other articles:
|
|
|
|
 
M. J. Rice
Evidence-Based Practice in Psychiatric Care: Defining Levels of Evidence
Journal of the American Psychiatric Nurses Association,
June 1, 2008;
14(3):
181 - 187.
[Abstract]
[PDF]
|
|
|
|
|
|
|
M. Shuchman MD and P. C. Hebert MD MHSc
Bringing a research base to psychiatry
Can. Med. Assoc. J.,
May 6, 2008;
178(10):
1257 - 1258.
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Shuchman MD and P. C. Hebert MD MHSc
Etablir une base de recherche en psychiatrie
Can. Med. Assoc. J.,
May 6, 2008;
178(10):
1259 - 1260.
[Full Text]
[PDF]
|
|
|
|
|
|
|
T. S. Stroup and J. R. Geddes
Randomized Controlled Trials for Schizophrenia: Study Designs Targeted to Distinct Goals
Schizophr Bull,
March 1, 2008;
34(2):
266 - 274.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. Barbui MD, T. A. Furukawa MD, and A. Cipriani MD
Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic re-examination of published and unpublished data from randomized trials
Can. Med. Assoc. J.,
January 29, 2008;
178(3):
296 - 305.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. James
Pharmacotherapy and child psychiatry: is there a way forward?: INVITED COMMENTARY ON... CHILD PSYCHIATRY AND ITS RELATIONSHIP WITH THE PHARMACEUTICAL INDUSTRY
Advan. Psychiatr. Treat.,
January 1, 2008;
14(1):
10 - 16.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. Barbui, S. Mule, and A. Cipriani
Haloperidol, risperidone and olanzapine are similarly effective for first-episode non-affective psychosis but have differing side effects
Evid. Based Ment. Health,
August 1, 2007;
10(3):
74 - 74.
[Full Text]
[PDF]
|
|
|
|
|
|
|
C Barbui and A Cipriani
Evidence-based psychopharmacology: an agenda for the future
Evid. Based Ment. Health,
February 1, 2007;
10(1):
4 - 6.
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. S. Brekke, K. Ell, and L. A. Palinkas
Translational Science at the National Institute of Mental Health: Can Social Work Take Its Rightful Place?
Research on Social Work Practice,
January 1, 2007;
17(1):
123 - 133.
[Abstract]
[PDF]
|
|
|
|
|
|
|
R. E. McCUE, R. WAHEED, L. URCUYO, G. ORENDAIN, M. D. JOSEPH, R. CHARLES, and S. M. HASAN
Comparative effectiveness of second-generation antipsychotics and haloperidol in acute schizophrenia
The British Journal of Psychiatry,
November 1, 2006;
189(5):
433 - 440.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. K Brandt, J. A Hind, J. Robbins, A. S Lindblad, G. Gensler, G. Gill, H. Baum, D. Lilienfeld, J. A Logemann, and Communication Sciences and Disorders Clinical Tria
Challenges in the design and conduct of a randomized study of two interventions for liquid aspiration
Clinical Trials,
October 1, 2006;
3(5):
457 - 468.
[Abstract]
[PDF]
|
|
|
|
|
|
|
T. R. Insel
Beyond Efficacy: The STAR{star}D Trial
Focus,
September 1, 2006;
4(4):
562.
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. S. Bauer, L. McBride, W. O. Williford, H. Glick, B. Kinosian, L. Altshuler, T. Beresford, A. M. Kilbourne, M. Sajatovic, and and Coauthors for the Cooperative Studies Program
Collaborative Care for Bipolar Disorder: Part I. Intervention and Implementation in a Randomized Effectiveness Trial
Psychiatr Serv,
July 1, 2006;
57(7):
927 - 936.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
T. R. Insel
Beyond Efficacy: The STAR*D Trial
Am J Psychiatry,
January 1, 2006;
163(1):
5 - 7.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Levin
NIMH Assesses Future Research Priorities
Psychiatr News,
June 3, 2005;
40(11):
32 - 34.
[Full Text]
|
|
|
Get information about faster international access.
Privacy Policy
Copyright © 2005
American Psychiatric Association.
All rights reserved.
Home
| Search
| Current Issue
| Past Issues
| Subscribe
| All APPI Journals
| Help
| Contact Us
|
