Consider your preliminary study design: What are your endpoints?
- Once a reasonable hypothesis developed, it is important to consider how it will be tested.
- The first requirement is that a comparison be made.
- Choosing the right control group is challenging, and subtle. Once the comparison group is chosen, the magnitude of expected difference should be estimated, as a basis for determining sample size (power calculation).
- Engage the support of a statistician to ensure a proper approach to this process. A statistician will help determine measures, sample size, what endpoints can be reasonably expected and what tests should be used for your analysis.
- In clinical research, standard methods include cohort studies (prospective, or retrospective; the randomized controlled clinical trial is a sub-category of the prospective cohort study) that assemble groups on the basis of exposure/intervention, and follow for outcome; and case-control studies that assemble groups on the basis of the outcome and assess for previous exposures.
- After determining your study design, revise your endpoints as required.
▪ BWH Patient-Centered Comparative Effectiveness Research Center Upcoming Events
▪ Comparative Effectiveness, Cost-Benefit Analysis, & Implementation Research (Harvard Catalyst)
▪ Design and Conduct of Clinical Trials
▪ Workshop on Study Design: Using MGH Clinical Care Data for Clinical Effectiveness Research