For more information on strategies for clinical trial education, and working with ethnically diverse populations.

A high school teacher who is a cancer survivor is finding ways to spread the word about clinical trials.

Because she is active in her church, she finds herself talking to many people whose lives have been touched by cancer. She says, "People call me the cancer lady, but I don't care." She is often asked to talk to fellow church members about her experience with cancer and her treatment on a clinical trial.

She says, "I used to think that clinical trials treated people like guinea pigs-a lot of folks do. I think people need to know the facts about clinical trials. No one likes to hear their own name associated with the word 'cancer.' But, how many times does someone hear about a co-worker, a friend, or a neighbor who was just diagnosed with cancer? That's how I approach other people. I tell them that it's important that cancer patients talk to their doctor about all their options. That's the best help that I can provide someone."

1. Who wrote this article?

   Any good news article should list the author, his or her institution, and if the author is not a reporter, his or her background. Reporters are trained to be objective, but they often report on what seems newsworthy and may miss key facts. Some institutions may not list the author of an article, in which case the institution itself should be considered the author. Newspapers often use "wire reports," such as the Associated Press (AP), and often include materials excerpted directly from press releases.

2. What is the basis of the information in the article?

   In addition to identifying who wrote the article you are reading, the evidence that material is based on should be provided. Medical facts and figures should have references (such as an article in a medical journal or the consensus of a meeting of experts reviewing research evidence); anecdotal evidence, opinions, or advice should be clearly set apart from information that is "evidence-based" (that is, based on research results).

3. Does the article say if the study involved people, animals, or cells in the laboratory?

   In early cancer research or preclinical testing, scientists test promising new cancer treatments in the laboratory and in animal models. This is done to find out if the treatment has an anticancer effect and if it is safely tolerated in animals. Only if a new drug proves promising in the lab, does it move to testing in humans. Clearly, preclincial research only suggests future direction, and cannot be applied directly to all people with a particular type of cancer.

4. Does the article include information on the phases of the study and number of participants?

   Clinical research is generally conducted in three different types of studies called phase 1, 2, and 3 studies, reflecting the order in which they take place. Each phase of a study has a different goal and, although they are often conducted separately they can be conducted as part of the same study.

   News articles may not mention the study phase. However, if an article refers to an "early" study, it generally refers to a phase 1 or 2 study. If an article discusses different groups of patients getting different types of treatment or different doses of a drug, or mentions that a study was "randomized," it usually means the study was a phase 3 study. Occasionally, phase 2 studies may be randomized.

5. If the study includes a new agent or device, has it been approved by FDA?

   The Food and Drug Administration (FDA), an agency of the U.S. Department of Health and Human Services, must review all test results for new agents to ensure that products are safe and effective for specific uses.

   FDA applies two key questions to each application for drug approval:

   • Do the results of well-controlled studies provide substantial evidence of effectiveness?

   • Do the results show the product is safe under the conditions of use in the proposed labeling? (In this context, "safe" means that potential benefits have been determined to outweigh any risks.)

   Only when FDA makes the approval does it allow the drug to be "labeled" for a specific use. This label includes information on what kinds of people should be given the drug, the dosage of the drug, and information on safety and adverse effects. It is only at this time that the new drug can be given to people outside of a clinical trial.

6. What were the characteristics of the people who participated in the study?

   Sometimes, studies are done only in specific groups of people-for example, people in a particular age group, or those whose cancer is at a particular stage. This may mean that the study results may not apply to those who are not members of these specific groups.

7. Does the article discuss the benefits and risks for those participating in the study in a balanced way?

   Just as there are potential side effects to all medications, there are benefits and risks to all clinical trials. The article should fully describe the known benefits and risks, as well as note that there may be side effects or risks that are unknown. If the article appears to be one-sided or overtly positive, you may be justified in having some skepticism about the author's motives.

8. Who funded the study?

   Studies can be funded from many sources. The most common sources in the United States are the Federal Government, universities, private foundations, or industry (such as pharmaceutical companies or companies making a device that is being tested). If a researcher has received funding from a source, such as the Federal Government, that uses a peer review process for evaluating and awarding research funds, the research findings will be more credible and less subject to bias than if the sponsor has a vested interest in the results.

9. Who conducted the study?

   It is important that research studies have scientific review and ongoing oversight. Studies that have been through this level of scrutiny are more likely to produce high quality results than those that have not been reviewed.

10. Were the study results "peer reviewed" or just announced at a meeting or through a press release?

    If the news article was based on a published article in a peer-reviewed journal, it means that other experts have examined and critiqued the researchers' methods and findings.