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Consider your preliminary study design: What are your endpoints?

Information:

  • 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.

Resources:

BWH Patient-Centered Comparative Effectiveness Research Center
Consultation with Clinical Research Program (CRP) Faculty

Courses:

ONLINE:
BWH Patient-Centered Comparative Effectiveness Research Center Past Events

LIVE TRAINING:
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

Please click here for a list of CRP current offerings. Many of the CRP's courses are recorded, click here to access our recordings and handouts.