Patient Resources

The following information and resources are available for patients and other individuals who want to learn more about clinical trials, cancer, and cancer treatment.

About Clinical Trials

A clinical trial is a health related study designed to evaluate a new drug or combination of drugs. These studies are done with human volunteers. Information gathered from clinical trials provides a basis for understanding how new therapies work, how effective they are, and if they are safe enough for use by the public.

If the results of a clinical trial demonstrate that the drug is beneficial and safe, the results are submitted to the appropriate regulatory agency, such as United States Food and Drug Administration (FDA) for review. The regulatory agency uses this information to determine whether or not to approve the drug.

What Are the Different Phases of Clinical Trials?

Clinical trials are performed in phases, each of which has a different purpose.

• Clinical trial, phase I: The first studies of a new drug candidate in people. Phase I studies are designed to evaluate how a new drug candidate should be given and identify the highest tolerated dose. They also evaluate the way the body absorbs, metabolizes, and eliminates the compound.
• Clinical trial, phase II: A phase II trial is designed to continue to test the safety of the drug candidate, and begins to evaluate whether and how well the new drug candidate works. Phase II trials often enroll large numbers of patients and may be conducted at many doctors’ offices, clinics, and cancer centers nationwide.
• Clinical trial, phase III: These studies test a new drug candidate, a new combination of drugs with or without a new drug candidate, or a new surgical procedure in comparison to the current standard of treatment or a placebo. A participant usually will be assigned randomly to either the standard treatment group or the new treatment group. Phase III trials often enroll large numbers of patients and may be conducted at many doctors’ offices, clinics, and cancer centers nationwide.

Should I Participate in a Clinical Trial?

Taking part in a clinical trial is one way to make a contribution. Information gathered during a clinical trial can lead to safer and more effective treatments.

However, it is important to keep in mind that there are both risks and benefits involved in clinical trials. Choosing to participate is an important and challenging decision that should be made only with a full understanding of the risks and benefits involved. This may require consultation with your doctor.

Learn as much as you can about the trial and the criteria for participation and consider discussing your decision with your doctor to see if the clinical trial you are considering is right for you.

Where Can I Learn More?

To learn more about clinical trials and what you need to consider before participating, visit www.clinicaltrials.gov/ct2/home. This site is an excellent resource for patients, care providers, and healthcare professionals. It provides a registry of federally and privately supported clinical trials being conducted in the United States and around the world. It also includes information about a trial’s purpose, who may participate, locations, and phone numbers for more details. If you are considering participating in a clinical trial, be sure to review the resource titled “Understanding Clinical Trials” at www.clinicaltrials.gov/ct2/info/understand.

Information about Clinical Trials

• ClinicalTrials.gov - This service of the National Institutes of Health was developed by the National Library of Medicine as a registry of federally and privately supported clinical trials conducted in the United States and around the world.
• Clinical trials on CTI’s investigational products
• Lung Cancer Alliance Clinical Trial Find a Match - This is the Lung Cancer Alliance’s clinical trial matching service.
• National Cancer Institute Clinical Trials - NCI’s clinical trials database can be searched using a search form that allows selection of a type of cancer, stage/subtype, type of trial, and location, as well as additional criteria, including:
• How to Find a Cancer Treatment Trial
• Search for Clinical Trials
• Learning About Clinical Trials
• Español

Government Agencies

• The European Agency for the Evaluation of Medicinal Products - The mission of this agency is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health.
• United States Food & Drug Administration’s Center for Drug Evaluation & Research - The Center for Drug Evaluation and Research (CDER) assures that safe and effective drugs are available to the American people.
• National Cancer Institute/Cancer.gov - NCI, as part of the U.S. National Institutes of Health, coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.