What is a clinical trial and how does a trial work?

Carefully conducted clinical trials are performed in human volunteers to provide answers to questions such as:

  • Does a treatment work?
  • Does it work better than other treatments?
  • Does it have side effects?

Clinical trials also provide important information on the cost-effectiveness of a treatment, the clinical value of a diagnostic test and how a treatment improves quality of life.

We conduct each trial according to a comprehensive plan, or protocol. The plan outlines the types of patients who can enter the trial, the schedule of tests and procedures, drugs and dosages, necessary follow up and the length of the study. It also describes the results (endpoints) that will be measured and the type of information to collect, which we then share with regulatory authorities to obtain marketing approval and with payers to get reimbursement.

Clinical trials are conducted in phases. Each phase is designed to answer certain questions, while taking steps necessary to safeguard the people taking part. Every new treatment is usually tested in three phases of clinical trials before regulatory agencies consider it safe and effective. Trials are also conducted according to Good Clinical Practice (GCP) guidelines that regulators require in order to protect patient safety.