Overview of clinical research design

American Journal of Health-System Pharmacy

Volumn 66, Issue 4, 2009, Pages 398-408

  Hartung, Daniel M ^a   Touchette, Daniel ^b  

^a OREGON STATE UNIVERSITY   (United States)

^b UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

Author keywords

Clinical studies; Methodology; Nomenclature

Indexed keywords

CASE CONTROL STUDY; CLINICAL RESEARCH; CLINICAL STUDY; COHORT ANALYSIS; CROSS-SECTIONAL STUDY; EXPERIMENTAL STUDY; METHODOLOGY; NOMENCLATURE; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RETROSPECTIVE STUDY; REVIEW; SYSTEMATIC ERROR; ARTICLE; EPIDEMIOLOGY; HUMAN; MEDICAL RESEARCH;

BIAS (EPIDEMIOLOGY); BIOMEDICAL RESEARCH; CASE-CONTROL STUDIES; COHORT STUDIES; CROSS-SECTIONAL STUDIES; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 59849100549     PISSN: 10792082     EISSN: None     Source Type: Journal    
DOI: 10.2146/ajhp080300     Document Type: Review

References (32)

1. Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet. 2002; 359:57-61.
2. Hennekens CH, Buring JE. Epidemiology in medicine. Boston: Little, Brown; 1987.
3. Hulley SB, Cummings SR, Browner WS et al. Designing clinical research: an epidemiologic approach. Philadelphia: Lippincot Williams & Wilkins; 2001.
4. Hill AB. The environment and disease: association or causation? Proc R Soc Med. 1965; 58:295-300.
5. Rothman KJ. Epidemiology: an introduction. New York: Oxford; 2002.
6. Grimes DA, Schulz KF. Bias and causal associations in observational research. Lancet. 2002; 359:248-52.
7. Sackett DL. Bias in analytic research. J Chronic Dis. 1979; 32:51-63.
8. Hulley S, Grady D, Bush T et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. JAMA. 1998;280:605-13.
9. Rossouw JE, Anderson GL, Prentice RL et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002; 288:321-33.
10. Ray WA. Evaluating medication effects outside of clinical trials: new-user designs. Am J Epidemiol 2003; 158: 915-20.
11. Grodstein F, Clarkson TB, Manson JE. Understanding the divergent data on postmenopausal hormone therapy. N Engl J Med. 2003; 348:645-50.
12. Hartung DM, Touchette DR, Bultemeier NC et al. Risk of hospitalization for heart failure associated with thiazolidinedione therapy: a Medicaid claims-based case-control study. Pharmacotherapy. 2005; 25:1329-36.
13. D'Agostino RB Jr. Propensity score methods for bias reduction in the comparison of a treatment to a nonrandomized control group. Stat Med. 1998; 17:2265-81.
14. Glynn RJ, Schneeweiss S, Stürmer T. Indications for propensity scores and review of their use in pharmacoepidemiology. Basic Clin Pharmacol Toxicol. 2006; 98:253-9.
15. Seeger JD, Williams PL, Walker AM. An application of propensity score matching using claims data. Pharmacoepidemiol Drug Saf. 2005; 14:465-76.
16. Grimes DA, Schulz KF. Cohort studies: marching towards outcomes. Lancet. 2002;359:341-5.
17. Schulz KF, Grimes DA. Case-control studies: research in reverse. Lancet. 2002; 359:431-4.
18. Zhang J, Yu KF. What's the relative risk?: a method of correcting the odds ratio in cohort studies of common outcomes. JAMA. 1998;280:1690-1.
19. Grimes DA, Schulz KF. Compared to what? Finding controls for case-control studies. Lancet. 2005; 365:1429-33.
20. Maclure M. The case-crossover design: a method for studying transient effects on the risk of acute events. Am J Epidemiol. 1991; 133:144-53.
21. Schneeweiss S, Stürmer T, Maclure M. Case-crossover and case-time-control designs as alternatives in pharmacoepidemiologic research. Pharmacoepidemiol Drug Saf. 1997; 6(suppl 3):S51-9.
22. Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. 3rd ed. New York: Springer-Verlag; 1998.
23. Miller FG, Rosenstein DL. The nature and power of the placebo effect. J Clin Epidemiol. 2006; 59:331-5.
24. Montori VM, Guyatt GH. Intention-to-treat principle. CMAJ. 2001; 165:1339-41.
25. Streiner DL. The case of the missing data: methods of dealing with dropouts and other research vagaries. Can J Psychiatry. 2002; 47:68-75.
26. Jones B, Jarvis P, Lewis JA et al. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996; 313:36-9. [Erratum, BMJ. 1996:313:550.]
27. Piaggio G, Elbourne DR, Altman DG et al. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006; 295:1152-60. [Erratum, JAMA. 2006; 296:1842.]
28. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003; 290:1624-32.
29. ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002; 288:2981-97. [Erratum, JAMA. 2003; 289:178.] [Erratum, JAMA. 2004; 291:2196.]
30. Ray WA. Policy and program analysis using administrative databases. Ann Intern Med. 1997; 127:712-8.
31. Shadish WR, Cook TD, Campbell DT. Experimental and quasi-experimental designs for generalized causal inference. Boston: Houghton Mifflin; 2002.
32. Wagner AK, Soumerai SB, Zhang F et al. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. 2002; 27:299-309.