Clinical Trials

  • Research the question (is it useful?)
  • Define the hypothesis (what do we think the answer is?)
  • Review the literature (has anyone else done this?)
  • Involve a statistician (how do I design this?)
  • Develop inclusion and exclusion criteria
  • Calculate the sample size (according to beta value and power)
  • Develop methodology (trial protocol)
  • Gain ethics approval
  • Perform a pilot study (and modify protocol as needed)
  • Perform the study (collect data)
  • Measure the outcomes
  • Analyse the data using appropriate statistical methods
  • Compare to null hypothesis (is the difference statistically significant?)
  • Consider sources of bias and errors
  • Submit for publication

Phases of clinical trials

  • Phase 1: healthy volunteers
  • Phase 2: Patients with the disease of interest
  • Phase 3: large scale trial on the patients with the disease
  • Phase 4:“post-marketing experience”