clinical trails

clinical trails

1. Control arm

   • whty? Spontaneous cure Side effects
   • How? Criteria Historical Ethical
   • Examples:
     • Standard care
     • Placebo
     • Careful follow-up
     • Early or late application of same intervention
     • lower dose level

2. Randomization

   • Means that subjects recruited from the study population are allocated to either intervention or control arm by chance. Random procedure DOES NOT equal haphazard procedure
   • Why Randomization?
     • Ensures comparability of the two arms regarding known and unknown factors.
     • Avoid selection bias
     • Provides basis for standard statistical analysis

3. Baseline measurements

   • Useful to check that comparability has been successfully achieved

4. Design of the trial

   • Methodology section should include the following:
     • Patient inclusion criteria.
     • Time of patients inclusion in the study
     • Presence of a comparison group
     • Matching criteria of the two groups
     • Method used for randomization

5. Blindness

   • Means ensuring that a person remains unaware of which arm a subject has been allocated to.
   • why blindness: To reduce selection bias And to avoid bias in outcome measures.
   • Blinding is not possible in all studies so, one needs to consider how important it is, and to what extent it can be achieved
   • Trials are often described as:
     • Single-blind: the subject participating in the trial
     • Double-blind: the subject & investigators (clinician, interviewers, laboratory personnel).
     • Triple blind: the subject, investigators & the committee responsible for monitoring outcome