Clinical Trials

Clinical trials contribute to medical science and advance potential treatments to help manage your conditions now and in the future.

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.

What are the different phases of clinical research studies (also known as clinical trials)?

Clinical research studies are divided into different phases. Each phase is designed to collect specific information about the investigational medication or treatment.

Phase 1 Trials

The first human tests of investigational medications or treatments are in Phase 1 studies. Phase 1 studies are designed to determine the most appropriate dose of the investigational medication and to check for any potential side effects. These studies usually involve a small number of participants and may involve a level of risk.

Phase 2 Trials

Phase 2 studies test the investigational medication in a larger group of patients to evaluate the effectiveness of the medication on the disease being studied and to confirm the safety data established in the Phase 1 study.

Many Phase 2 studies compare the investigational medication to a placebo (inactive medication) or an existing standard treatment. For clinical trials involving a placebo, participants have a chance to receive the investigational medication but also have a chance to receive the inactive medication.

As with every other study, patients in Phase 2 studies are closely monitored by the study team throughout their participation in the study.

Phase 3 Trials

In Phase 3 clinical research studies, basic information is known about the investigational medication from results collected in earlier studies. Phase 3 studies test the safety and how well the investigational medication works in hundreds or even thousands of participants. Phase 3 studies also often compare the investigational medication to a placebo (inactive medication) or an existing standard treatment.

Phase 4 Trials

These clinical research studies are conducted after the regulatory authorities have approved a medication and it is available for use by the general public. Phase 4 trials may evaluate the long-term safety of the approved medication.