​The guidelines that clinical trials follow clearly state who will be able to join the study and the treatment plan. Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the study, called a protocol, which is like a recipe for conducting a clinical trial.

The protocol explains what the trial will do, how the study will be carried out, and why each part of the study is necessary. It includes information about:

  • The reason for doing the study
  • Who can join the study
  • How many people are needed for the study
  • Any drugs the participants will take, the dose, and how often
  • What medical tests participants will have and how often
  • What information will be gathered about participants
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Adapted from National Cancer Institute

Last reviewed: 10/11/2018
Last modified: 1/4/2019 6:39 AM