Empowering Recovery on Your Journey to Wellness

A clinical trial is a research study in which volunteers receive investigational medical products developed by pharmaceutical and biotechnology companies. Qualified physicians called Investigators, as well as other research professionals, are selected by the sponsoring companies to conduct these trials in order to determine the benefits of their investigational drugs.

Clinical trials are usually conducted in four phases—phase I, phase II, phase III and phase IV. A small number of people participate in phase I trials while the later phases encompass a larger number of volunteers.

There are guidelines that determine who can participate. First, a volunteer must qualify for the study. Criteria permitting volunteers to participate in a clinical trial are called “inclusion criteria.” Factors that disallow volunteers from participating are called “exclusion criteria.” Age, gender, the type and stage of a disease, previous treatment history, and other medical conditions are examples of such criteria.

Second, some clinical trials seek participants with specific illnesses or conditions to be studied. Others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participant safety, and ensure that researchers learn the information they need.

In a clinical trial, a volunteer is usually assigned to 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 volunteer during the study. Regardless of which treatment is received, however, the level of medical attention and respect that each participant receives is the same.

Patients considering participating in a clinical trial should talk about it with their physicians and medical caregivers. They should also understand the credentials and experience of the staff and facility involved in conducting the study. Questions to ask a physician or medical caregiver:

• How long will the trial last?
• Where is the trial being conducted?
• What treatments will be used and how?
• What is the main purpose of the trial?
• How will patient safety be monitored?
• Are there any risks involved?
• What are the possible benefits?
• Do I have to pay for any part of the trial?

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

Prior to participating, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent, a process that can help you decide if participating in a trial is right for you.

When you give written consent to participate in a clinical trial, you acknowledge that you understand and accept all aspects of the research study, including any risks or benefits involved. However, informed consent is not strictly about signing a document. It is a process that involves ongoing conversations between you and the research staff before, during and even after you decide to become a study volunteer.

To begin, the research staff is obligated to discuss all the pertinent information about the trial with you, its purpose, the procedures involved, the potential risks and benefits. It is your responsibility to ask questions if there is something you don’t understand. You can ask the researcher to repeat the information or explain it in another way using everyday words.

If English is not your first language, research centers can and should be able to produce documents or explanations for you in your preferred language. If not, you shouldn’t participate in the study.

In some instances, a single visit may not be enough time for you to fully understand the information provided. Therefore, it is essential to take the time you need to make an informed decision.