Clinical Trials

New treatments for colorectal cancer or new ways of preventing it are developed in a process that begins in the laboratory and moves through through an orderly process of testing with cells, in animals, and finally in groups of people. The goal is to discover new therapies that are both safe and effective and offer an advantage over existing treatments.

Clinical trials test new ways of treating, diagnosing, or preventing colorectal cancer in people. Trials also test ways to manage side effects or focus on how to personalize treatment based on characteristics of individuals or molecular features of their tumors.

In some trials, participants are randomized to one of two or more treatment regimens or arms. One arms usually is the current standard treatment, other arms include investigational drugs or strategies. Randomization avoids the bias of doctors or patients choosing which arm of the trial to be part of.

Why should I consider a clinical trial?

Clinical trials provide the information researchers use to move cancer treatment forward. Current standard cancer therapy cancer evolved through the clinical trial process. By participating in a clinical trial, you will contribute to knowledge about cancer that can help others.

In addition, a clinical trial may help you. While it is important to realize that the major goal of clinical trials is scientific — to test new treatments — patients who take part in trials benefit by:

Potentially having access to an experimental drug or new cancer treatment not available outside a clinical trial.
Receiving medical care from a team of health professionals who follow a carefully designed protocol based on the latest known evidence about cancer care. Protocols are reviewed before and during the trial to be sure that patient safety and interests are protected.
Knowing they are helping other people suffering from colorectal cancer.

Are there risks involved in clinical trials?

Trial participants are rigorously protected in clinical trials. Trial procedures are reviewed by researchers and their peers, Institutional Review Boards (IRBs) and – in some cases, by patient advocates, the NCI and the FDA – to ensure patient safety. However, you need to think about:

New treatments are not always better than the standard treatment that is currently available. In some situations they may be less effective that what exists.
There may be unexpected side effects to a treatment or side effects may be worse than standard treatment.
Patients in randomized clinical trials cannot choose their treatment, nor can their doctors.
Some costs of clinical trials may not be paid. Routine medical care is usually, but not always, covered by your insurance and extra tests or scans or experimental requirements paid for by the trial. It is important to check with your insurance company to be sure they will cover routine care.
You may have extra out-of-pocket expenses for travel and family responsibilities.

Where Can You Go for More Information

National Cancer Institute Clinical Trials: Questions and Answers provides detailed information with links to more specific web pages to answer questions about clinical trials and clinical trial participation.

CancerActionNow.Org, a project of the Marti Nelson Cancer Foundation, provides information about the drug development process and clinical trials. They also have help with expanded access and compassionate use for patients in need of an experimental drug who don’t qualify for a clinical trial.

Genentech, developers of Avastin®, have an excellent FAQ on their site with questions and answers about participating in clinical trials, including questions to ask your doctor before deciding on a clinical trial.

The National Cancer Institute has a Resource Guide to Clinical Trials and Insurance Coverage that provides more information about covering clinical trials costs, states that require insurance coverage for clinical trials, and Medicare policies on clinical trial coverage.

The University of Pittsburgh Medical Center has an excellent website that includes frequently asked questions about clinical trials and an interactive, video-based program Meet, Ask, Understand.

Last Update: January 9, 2009