In this lesson, among other things, we learned:
- the 6 objectives that will be met with proper trial design.
- the sources of potential bias in clinical studies.
- the design strategies to reduce bias, variability, and ‘placebo effects’ in a proposed clinical study.
- to compare and contrast the following study designs with respect to the ability of the investigator to minimize bias: Case report or case series, database analysis, prospective cohort study, case-control study, parallel design clinical trial, crossover clinical trial.
- to identify the experimental unit in a proposed study.
- to differentiate between Phases I-IV trials.
- to recognize features that should be described in a written protocol for a clinical trial
- Identify the characteristics and purposes of translational studies.
References for Lesson 3 Section
Dansinger et al. Comparison of the Atkins, Ornish, Weight Watchers, and Zone Diets for Weight Loss and Heart Disease Risk Reduction: A Randomized Trial. JAMA. 2005;293:43-53.
Ellison, N.M. et al. Special Report on Laetrile : The NCI Laetrile Review. NEnglJMed. 1978; 229; 549-552.
Milazzo S, Ernst E, Lejeune S, Schmidt K. Laetrile treatment for cancer. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD005476. DOI: 10.1002/14651858.CD005476.pub2 This version first published online: April 19. 2006; Accessed 7/25/07
Piantadosi Steven. (2005) Clinical Trials as Experimental Designs, Random Error and Bias, Objectives and Outcomes, Translational Clinical Trials, Dose-Finding Designs. In: Piantadosi Steven. Clinical Trials: A Methodologic Perspective. 2nd ed. Hobaken, NJ: John Wiley and Sons, Inc.