Clinical Trials

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.

Regulated in the United States by the Food and Drug Administration (FDA), clinical trials help advance healthcare by testing the effectiveness and safety of a therapeutic agent (drug, vaccine or device) using consenting human subjects. The American Lung Association wants our patient and caregiver visitors to be aware of the following clinical trial programs:

CenterWatch Clinical Trial Research Center – For one of the web's largest listings of clinical trials that are actively recruiting patients, click here to visit the CenterWatch site. CenterWatch provides patients and their advocates information on clinical trials, specific drugs, as well as other essential health and educational resources:

  • Search clinical trials
  • Receive e-mail notifications about specific clinical trials
  • Review results from completed clinical trials
  • Search drug information
  • Learn about volunteering for a clinical trial
  • Read an overview of the clinical trials process
  • Find other health and educational resources

ClinicalTrials.gov - Is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.  ClinicalTials.gov is a service of the U.S. National Institutes of Health.

Volunteering for a Clinical Trial

When considering volunteering for a clinical trial, it is important to make an informed decision. Below are answers to frequently asked questions that many potential volunteers have about participating in a study.

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 "criteria" These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note such 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 study treatment or drug while other volunteers may receive a placebo (an inactive ingredient) or a treatment already available. 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?  Patients considering participating in a clinical trial should talk about it with their doctors and family members/caregivers. Questions to ask include:

  • How long will the trial last?
  • Where is it 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?
  • 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?
  • What happens if I am harmed by the trial?
  • Can I opt to remain on this treatment, even after termination of the trial?

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.  Travel expenses are often covered.

What are the benefits and risks of joining a trial?  Volunteers in a clinical trial participate in the development of medical therapies that may offer better treatments and even cures for life-threatening and chronic diseases. However, there are risks involved.

Possible benefits for volunteers:

  • Play an active role in their health care.
  • Gain access to research treatments before they are widely available.
  • Obtain medical care at health care facilities during the trial.
  • Help others by contributing to medical research.

Possible risks for volunteers:

  • There may be unpleasant, serious, or even life-threatening side effects to experimental treatment.
  • The experimental treatment may not be effective.
  • The protocol may require more time and attention than a non-protocol treatment, including trips to the study site, more treatments, hospital stays, or complex dosage requirements.

Please note: volunteers may withdraw from a study at any time for any reason.

This information is from CenterWatch.  Another good source of information is the U.S. National Institutes of Health