What is a clinical trial?

Clinical trials or research studies are carefully designed and monitored studies to test and evaluate investigational medications, devices or procedures. Once a medication, device or procedure is shown to be well-tolerated and effective, it may be considered for approval by regulatory authorities. Clinical trials are very well regulated and have inherent safeguards to protect participants.

Who can participate in a clinical trial?

All clinical trials have specific criteria for inclusion (factors that allow for participation) and exclusion (factors that don’t allow participation) in order to identify appropriate participants. Before joining a clinical trial, participants must qualify by meeting the inclusion criteria. When people are not qualified for a trial, it is not a personal rejection, but instead intended to protect their safety and well-being.

Why participate in a clinical trial?

  • Have the opportunity of potentially receiving new research treatments before they are widely available
  • Receive careful monitoring from medical staff throughout the study
  • Receive study-related medical exams and tests at no cost
  • Become more educated about medical conditions
  • Play an active role in one’s own healthcare
  • Help others by contributing to medical research

How is a participant’s safety protected?

Medical practice is governed by ethical and legal codes which also apply to clinical research. Each clinical trial must follow a specific and structured protocol, a study plan which details how the clinical trial will be carried out. Individual participants’ names will remain confidential as researchers report results from the trial. While enrolled in a clinical trial, a participant’s health and progress will be closely monitored by the study staff which usually consists of an investigator (doctor) and study coordinator.

A participant can withdraw from a study at any time, even after signing informed consent. Upon leaving a clinical trial, it is best if a participant makes the study team aware they will be discontinuing and also the reasons why.

What is a placebo?

A placebo is an inactive pill, liquid or powder that has no treatment value. The purpose of a placebo in clinical research is to be able to compare those taking the investigational treatment versus those not on the investigational medication.

In research, participants on placebo (non-medication) or standard treatment are often referred to as the control group. Those participants on the investigational medication or treatment are often referred to as the experimental group.

What are the different kinds of studies?

  • A single-blind study is when the researcher is aware who belongs to the control group and who belongs to the experimental group
  • A double-blind study is when the researcher as well as the participants are unaware of who belongs to the control and experimental groups.
  • An open-label study is when no standard treatment or placebo is utilized. All participants receive investigational medication, device or procedure.