Clinical trials: Bridging the gap between efficacy and effectiveness

References

• Administration on Aging. Fact sheet on global aging. 2006, Available on http://www.aoa.gov/press/fact/fact.asp
   Google Scholar
• Bebbington PE, Angermeyer M, Azorin JM, Brugha T, Kilian R, Johnson S, et al. The European schizophrenia cohort (Eurosc): A naturalistic prognostic and economic study. Social Psychiatry And Psychiatric Epidemiology 2005; 40: 707–717
   PubMed Web of Science ®Google Scholar
• Berwick DM. A user's manual for the iom's 'quality chasm' report. Health Affairs 2002; 21: 80–90
   PubMed Web of Science ®Google Scholar
• Cassidy F, Ahearn EP, Carroll BJ. Substance abuse in bipolar disorder. Bipolar Disorders 2001; 3: 181–188
   PubMed Web of Science ®Google Scholar
• Dunn LB, Lindamer LA, Palmer BW, Golshan S, Schneiderman LJ, Jeste DV. Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. American Journal of Geriatric Psychiatry 2002; 10: 142–150
   PubMed Web of Science ®Google Scholar
• Glasgow RE, Davidson KW, Dobkin PL, Ockene J, Spring B. Practical behavioral trials to advance evidence-based behavioral medicine. Annals of Behavioral Medicine 2006; 31: 5–13
   PubMed Web of Science ®Google Scholar
• Hamilton M. Development of a rating scale for primary depressive illness. British Journal of Psychiatry 1967; 6: 278–296
   Google Scholar
• Haro JM, Salvador-Carulla L. The SOHO (schizophrenia outpatient health outcome) study: Implications for the treatment of schizophrenia. CNS Drugs 2006; 20: 293–301
   PubMed Web of Science ®Google Scholar
• Johnson RE, McFarland BH. Lithium use and discontinuation in a health maintenance organization. American Journal of Psychiatry 1996; 153: 993–1000
   PubMed Web of Science ®Google Scholar
• Jones PB, Barnes TR, Davies L, Dunn G, Lloyd H, Hayhurst KP, et al. Randomized controlled trial of the effect on quality of life of second- versus first-generation antipsychotic drugs in schizophrenia: Cost utility of the latest antipsychotic drugs in schizophrenia study (CUtLASS 1). Arch Gen Psychiatry 2006; 63: 1079–1087
   PubMed Web of Science ®Google Scholar
• Kaufman J, Charney D. Comorbidity of mood and anxiety disorders. Depression and Anxiety 2000; 12: 69–76
   PubMed Web of Science ®Google Scholar
• Kobak KA, Engelhardt N, Lipsitz JD. Enriched rater training using internet based technologies: A comparison to traditional rater training in a multi-site depression trial. Journal of Psychiatric Research 2006; 40: 192
   PubMed Web of Science ®Google Scholar
• Kraemer HC, Robinson TN. Are certain multicenter randomized clinical trial structures misleading clinical and policy decisions?. Contemporary Clinical Trials 2005; 26: 518
   PubMed Web of Science ®Google Scholar
• Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Archives of General Psychiatry 2002; 59: 877–883
   PubMed Web of Science ®Google Scholar
• Lavori P, Rush AJ, Wisniewski SR, et al. Strengthening clinical effectiveness trials: Equipoise stratified randomization. Biological Psychiatry 2001; 50: 792–801
   PubMed Web of Science ®Google Scholar
• Lebowitz BD. The future of clinical research in mental disorders of late life. Schizophrenia Research 1997; 27: 261–267
   PubMed Web of Science ®Google Scholar
• Lebowitz BD. Clinical trials in late life: New science in old paradigms. Gerontologist 2004; 44: 452–458
   PubMed Web of Science ®Google Scholar
• Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. New England Journal of Medicine 2005; 353: 1209–1223
   PubMed Web of Science ®Google Scholar
• Minkler M, Blackwell AG, Thompson M, Tamir H. Community-based participatory research: Implications for public health funding. American Journal of Public Health 2003; 93: 1210–1213
   PubMed Web of Science ®Google Scholar
• Nierenberg AA, Ostacher MJ, Calabrese JR, Ketter TA, Marangell LB, Miklowitz DJ, et al. Treatment-resistant bipolar depression: A STEP-BD equipoise randomized effectiveness trial of antidepressant augmentation with lamotrigine, inositol, or risperidone. American Journal of Psychiatry 2006; 163: 210–216
   PubMed Web of Science ®Google Scholar
• Nierenberg AA, Trivedi MH, Ritz L, Burroughs D, Greist J, Sackeim H, et al. Suicide risk management for the sequenced treatment alternatives to relieve depression study: Applied NIMH guidelines. Journal of Psychiatric Research 2004; 38: 583–589
   PubMed Web of Science ®Google Scholar
• Norquist G, Lebowitz B, Hyman S. Expanding the frontier of treatment research. Prevention and Treatment 1999; 2
   Google Scholar
• Perlick DA, Rosenheck RA, Kaczynski R, Swartz MS, Canive JM, Lieberman JA. Components and correlates of family burden in schizophrenia. Psychiatric Services 2006; 57: 1117–1125
   PubMed Web of Science ®Google Scholar
• Perlis RH, Ostacher MJ, Patel JK, Marangell LB, Zhang H, Wisniewski SR, et al. Predictors of recurrence in bipolar disorder: Primary outcomes from the systematic treatment enhancement program for bipolar disorder (STEP-BD). American Journal of Psychiatry 2006; 163: 217–224
   PubMed Web of Science ®Google Scholar
• Piantodosi S. Clinical trials: A methodological perspective. Wiley, New York 2005
   Google Scholar
• Rosenbaum P, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika 1983; 70: 41–55
   Web of Science ®Google Scholar
• Rosenheck RA, Leslie DL, Sindelar J, Miller EA, Lin H, Stroup TS, et al. Cost-effectiveness of second-generation antipsychotics and perphenazine in a randomized trial of treatment for chronic schizophrenia. American Journal of Psychiatry 2006; 163: 2080–2089
   PubMed Web of Science ®Google Scholar
• Rubin DB. Inference and missing data. Biometrika 1976; 63: 581–592
   Web of Science ®Google Scholar
• Rush AJ, Fava M, Wisniewski SR, Lavori PW, Trivedi MH, Sackeim HA, et al. Sequenced treatment alternatives to relieve depression (STAR*D): Rationale and design. Control Clinical Trials 2004; 25: 119–142
   PubMedGoogle Scholar
• Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, et al. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIS for depression. New England Journal of Medicine 2006; 354: 1231–1242
   PubMed Web of Science ®Google Scholar
• Sachs GS, Thase ME, Otto MW, Bauer M, Miklowitz D, Wisniewski SR, et al. Rationale, design, and methods of the systematic treatment enhancement program for bipolar disorder (STEP-BD). Biological Psychiatry 2003; 53: 1028–1042
   PubMed Web of Science ®Google Scholar
• Schneider L, Olin J, Lyness S, Chui H. Eligibility of Alzheimer's disease clinic patients for clinical trials. Journal of the American Geriatrics Societ 1997; 45: 923–928
   PubMed Web of Science ®Google Scholar
• Schneider LS, Ismail MS, Dagerman K, Davis S, Olin J, McManus D, et al. Clinical antipsychotic trials of intervention effectiveness (CATIE): Alzheimer's disease trial. Schizophrenia Bulletin 2003; 29: 57–72
   PubMed Web of Science ®Google Scholar
• Schneider LS, Tariot PN, Lyketsos CG, Dagerman KS, Davis KL, Davis S, et al. National Institute of Mental Health clinical antipsychotic trials of intervention effectiveness (CATIE): Alzheimer disease trial methodology. American Journal of Geriatric Psychiatry 2001; 9: 346–360
   PubMed Web of Science ®Google Scholar
• Stroup S, Appelbaum P, Swartz M, Patel M, Davis S, Jeste D, et al. Decision-making capacity for research participation among individuals in the CATIE schizophrenia trial. Schizophrenia Research 2005; 80: 1–8
   PubMed Web of Science ®Google Scholar
• Stroup TS, Appelbaum PS. Evaluation of ‘subject advocate’ procedures in the clinical antipsychotic trials of intervention effectiveness (CATIE) schizophrenia study. Schizophrenia Bulletin 2006; 32: 147–152
   PubMed Web of Science ®Google Scholar
• Stroup TS, McEvoy JP, Swartz MS, Byerly MJ, Glick ID, Canive JM, et al. The National Institute of Mental Health clinical antipsychotic trials of intervention effectiveness (CATIE) project: Schizophrenia trial design and protocol development. Schizophrenia Bulletin 2003; 29: 15–31
   PubMed Web of Science ®Google Scholar
• Trivedi MH, Fava M, Wisniewski SR, Thase ME, Quitkin F, Warden D, et al. Medication augmentation after the failure of SSRIS for depression. New England Journal of Medicine 2006; 354: 1243–1252
   PubMed Web of Science ®Google Scholar
• Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: Increasing the value of clinical research for decision making in clinical and health policy. Journal of the American Medical Association 2003; 290: 1624–1632
   PubMed Web of Science ®Google Scholar
• Warden D, Rush AJ, Trivedi M, Ritz L, Stegman D, Wisniewski SR. Quality improvement methods as applied to a multicenter effectiveness trial - STAR*D. Contemporary Clinical Trials 2005; 26: 95–112
   PubMed Web of Science ®Google Scholar
• Weissman MM, Pilowsky DJ, Wickramaratne PJ, Talati A, Wisniewski SR, Fava M, et al. Remissions in maternal depression and child psychopathology: A STAR*D-child report. Journal of the American Medical Association 2006; 295: 1389–1398
   PubMed Web of Science ®Google Scholar
• Wells K, Miranda J, Bruce ML, Alegria M, Wallerstein N. Bridging community intervention and mental health services research. American Journal of Psychiatry 2004; 161: 955–963
   PubMed Web of Science ®Google Scholar
• Wells KB. Treatment research at the crossroads: The scientific interface of clinical trials and effectiveness research. American Journal of Psychiatry 1999; 156: 5–10
   PubMed Web of Science ®Google Scholar
• Wisniewski SR, Eng H, Meloro L, Gatt R, Ritz L, Stegman D, et al. Web-based communications and management of a multi-center clinical trial: The sequenced treatment alternatives to relieve depression (STAR*D) project. Clinical Trials 2004; 1: 387–398
   PubMedGoogle Scholar
• Yusuf S, Collins R, Peto R. Why do we need some large, simple, randomized trials?. Statistics in Medicine 1984; 3(4)409–422
   PubMed Web of Science ®Google Scholar
• Zerhouni EA. Clinical research at a crossroads: The NIH roadmap. Journal of Investigational Medicine 2006; May 54(4)171–173
   PubMed Web of Science ®Google Scholar
• Zimmerman M, Mattia JI, Posternak MA. Are subjects in pharmacological treatment trials of depression representative of patients in routine clinical practice?. American Journal of Psychiatry 2002; 159: 469–473
   PubMed Web of Science ®Google Scholar