How to Design a Clinical Trial

A clinical trial is a prospective study that evaluates the effects of one or more interventions against a control. A health intervention can either be a drug, a medical device or a procedure. Clinical trials are the most effective tool for assessing positive and negative effects of a health intervention. They enable improvements of quality of care through comparing alternative treatments.

Instructions

• 1

  Design your control group carefully, because that's the group that you want to compare the intervention groups against. At the beginning of the trial, the control group must be sufficiently similar to the intervention groups.

• 2

  Define the primary question of the trial. Each trial should consist of only one primary question. The primary question should be stated in advance before the trial. You can also define a set of secondary questions related to the primary question.

• 3

  Write a clear and concise protocol for the clinical trial. The study protocol is the agreement between trial investigators and participants. The protocol should not be changed during the course of the trial. The protocol will clearly define the objectives of the study, the eligibility criteria for participants, and the size of the trial.

• 4

  Use randomization to assign participants to the intervention and the control groups. This guarantees that all participants are equally likely to join either the control group or any of the intervention groups. Randomization reduces the effects of allocation bias.

• 5

  Minimize bias during data collection and assessment by using double-blind design. In a double-blind study, both participants and investigators do not know which group (control or intervention) a participant belongs to.