What is a clinical trial?

A clinical trial is a research study in which volunteers receive investigational treatments under the supervision of a physician and other research professionals. These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians, also known as investigators, to conduct clinical trials to determine the benefits of investigational drugs.

Clinical trials are usually conducted in three phases (I, II, III). Only a small number of people participate in phase I trials while the later phases involve a larger number of volunteers.

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study. The factors that allow volunteers to participate in a clinical trial are called “inclusion criteria” and the factors that disallow volunteers from participating are called “exclusion criteria.” These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participants’ safety, and ensure that researchers learn the information they need.

How does a clinical trial work?

In a clinical trial, a volunteer is usually assigned a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while other volunteers may receive a placebo or a treatment already available.

A placebo is an inactive product used to assess the experimental treatment’s effectiveness. The participant, physician, and research staff may not know which volunteer receives a placebo and which receives the active treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteers during the study. Regardless of which treatment volunteers receive, however, the level of medical attention and care that each receives is the same.

What questions should be asked before choosing to participate?

  • What is the purpose of the trial?
  • How long will the trial last?
  • Where is the trial being conducted?
  • What treatments will be used and how?
  • How will patient safety be monitored?
  •  Are there any risks involved?
  • What are the possible benefits?
  • What are the alternative treatments besides the one being tested in the trial?
  •  Who is sponsoring the trial?
  •  Do I have to pay for any part of the trial?
  • Can I opt to remain on this treatment, even after termination of the trial?
  • How can I involve my family doctor in the care I receive?
  • Why do some studies use a placebo (an inactive product that looks like the study drug)?
  • Can I take my regular medications while I’m involved in a study?
  • What happens if I have a problem while I’m enrolled in a study?
  • What if I decide that the study is no longer in my best interest?

What can volunteers expect if they choose to participate?

In some studies, participants receive a physical examination and their medical histories are reviewed by either the study physician or a research staff member once they are enrolled in the study. The volunteers’ health will continue to be monitored during and after the trial. A detailed description of what’s expected of volunteers will be outlined in consent forms along with specific clinical trial information.

Why Do People Become Involved in Clinical Trials?

By participating, you may contribute to the healthcare of tomorrow and take a step towards improving and educating yourself about your own health. You may have a positive impact on the health of millions — perhaps even your own friends and loved ones. Research studies can allow you access to medical options and medications not available through any other means. Generally, all study procedures, doctor visits, and study medications are at no cost to you and financial compensation is available for your time and travel expenses. Additional financial compensation may be available to qualified volunteers. You do not need health insurance in order to participate.

What are the Risks Involved in Clinical Trials?

With each clinical trial, you are given information outlining the pros and cons of the drug or device being researched. Adverse events, sometimes serious in nature, are a possibility. You are closely monitored by the physician, as well as the study team, to treat any such event. Most study participants are not negatively affected by the drug or device that they are assisting in researching, but if something does happen, your study team will address it and respond to you quickly. You will be provided a 24-hour answer telephone contact number for such events or any other study related concerns that you might have.

What is a Placebo?

A placebo is a benign substance designed to resemble the drug being tested. It is used as a control to rule out any bias. Most well-designed studies include a control group which is unwittingly taking a placebo.

Do all Clinical Trials Include Placebos?

Each study is designed individually and therefore the use of placebos is based on that study design. A large majority of trials are placebo laced trials, however stage IV trials typically are not balanced with a placebo as a control.