Why Volunteer? Clinical Trials of Medical Treatments

The Food and Drug Administration, or FDA, is part of the United States government. It is FDA's job to make sure medical treatments are safe and effective for people to use.

What is a Clinical Trial?

"Clinical trial" is the scientific term for a test or study of a drug or medical device in people. These tests are done to see if the drug or device is safe and effective for people to use. Doctors and other health professionals run the tests according to strict rules set by the Food and Drug Administration (FDA). FDA sets the rules to make sure that people who agree to be in the studies are treated as safely as possible.

Why Should Minorities and Women Participate In Clinical Trials?

In the past, most drug testing has been done on white men. This means that some groups, such as African Americans, Hispanic Americans, American Indians, Asian Americans, and women, have not always been included in the tests done on drugs. But sometimes drugs work differently on people in these groups than on white men. So FDA wants people from many different groups included in these studies.

Points to Remember

Clinical trials are tests of medical treatments to see if they are safe and if they work.
Before you agree to take part in a study, you must be given complete information about the study, including possible side effects and benefits.
You must sign a special agreement called "Informed Consent" before taking part in the study.
You can leave the study at any time.

Informed Consent Protects Volunteers

To help you decide if you want to be a volunteer in a study, FDA requires that you be given complete information about the study before you agree to take part. This is known as informed consent. FDA requires that volunteers be told:

that the study involves research of an unproven drug or device
the purpose of the research
how long the study is expected to take
what will go on in the study and which parts of the study are experimental
possible risks or discomforts
possible benefits
other procedures or treatments that you might want to consider instead of the treatment being studied
that FDA may inspect study records, but the records will be kept confidential
whether any medical treatments are available if you are hurt, what those treatments are, where they can be found, and who will pay for the treatment
the person to contact with questions about the study, your rights, and injuries related to research
being in the study is voluntary and you can quit at any time.

Informed consent information should be written so you can understand it. If you don't, be sure to ask the doctor or other medical person to explain it. Make sure you understand all of it before you agree to be in the study.

Before you can participate in the trial, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is NOT a contract and you can leave the study at any time, for any reason.

Other Ways Volunteers Are Protected

Institutional Review Boards (IRBs) -- Scientists, doctors and other people from the local community serve on IRBs to review and monitor their hospital's or research institution's medical research involving people. They monitor studies to help make sure that there is the least possible risk to volunteers and that the risks are reasonable in relation to the expected benefits. IRBs make sure volunteer selection is fair and that informed consent is done correctly.
Data Monitoring Committees -- These committees are used mainly when one treatment is being compared with another and in studies where treatments are selected for patients at random. These committees are particularly important in tests of treatments for serious or life-threatening disease. These experts review information from studies to make sure they are being done in a way that is safest for the volunteers. During a study, if the committee finds that the treatment is harmful or of no benefit, it will stop the study. If there is evidence that one treatment gives a greater benefit than another, the committee stops the study and all volunteers are offered the better treatment.
FDA Inspections -- FDA inspects records and various scientists, clinics, and other research sites involved in a study. To make sure volunteers are being protected and studies are being done correctly, from time to time such inspections are done in response to complaints.

Why Volunteer?

By taking part in a clinical trial, you can try a new treatment that may or may not be better than those already available. You can also contribute to better understanding of how the treatment works in people of different ethnic backgrounds and genders.

What Are the Risks?

Many studies require that neither the patient nor the doctor know whether the patient is receiving the experimental treatment, the standard treatment or a placebo (an inactive substance that looks like the drug being tested). In other words, some volunteers may be getting no treatment at all.

Some treatments that are being tested have side effects that can be unpleasant, serious or even life-threatening. Because the treatments being studied are new, doctors don't always know what the side effects will be. Many side effects are temporary and go away when the treatment is stopped. But others can be permanent. Some side effects appear during treatment, while others may not show up until after the treatment is over. The risks depend on the treatment being studied and should be fully explained to you in the informed consent material.

Questions to Ask

Here are some questions to ask your doctor to help you decide if you want to take part in a clinical trial:

What is the study trying to find out?
What kinds of test and exams will I have to take while I'm in the study?
How much time do these take? What is involved in each test?
How often does the study require me to go to the doctor or clinic?
Will I be hospitalized? If so, how often and for how long?
What are the costs to me? Will my health insurance pay for it?
What follow-up will there be?
What will happen at the end of the study?
What are my other treatment choices? How do they compare with the treatment being studied?
What side effects can I expect from the treatment being tested? How do they compare with side effects of standard treatment? How long will the study last?

Total Fat, Saturated Fat, *Trans* Fat, and Cholesterol Content Per Serving*
Product	Common Serving Size	Total Fat g	Sat. Fat g	%DV for Sat. Fat	Trans Fat g	Combined Sat. & Trans Fat g	Chol. mg	%DV for Chol.
French Fried Potatoes± (Fast Food)	Medium (147 g)	27	7	35%	8	15	0	0%
Butter**	1 tbsp	11	7	35%	0	7	30	10%
Margarine, stick†	1 tbsp	11	2	10%	3	5	0	0%
Margarine, tub†	1 tbsp	7	1	5%	0.5	1.5	0	0%
Mayonnaise†† (Soybean Oil)	1 tbsp	11	1.5	8%	0	1.5	5	2%
Shortening±	1 tbsp	13	3.5	18%	4	7.5	0	0%
Potato Chips±	Small bag (42.5 g)	11	2	10%	3	5	0	0%
Milk, whole±	1 cup	7	4.5	23%	0	4.5	35	12%
Milk, skim†	1 cup	0	0	0%	0	0	5	2%
Doughnut±	1	18	4.5	23%	5	9.5	25	8%
Cookies± (Cream Filled)	3 (30 g)	6	1	5%	2	3	0	0%
Candy Bar±	1 (40 g)	10	4	20%	3	7	<5	1%
Cake, pound±	1 slice (80 g)	16	3.5	18%	4.5	8	0	0%
Nutrient values rounded based on FDA's nutrition labeling regulations. * Butter values from FDA Table of Trans Values, 1/30/95. † Values derived from 2002 USDA National Nutrient Database for Standard Reference, Release 15. †† Prerelease values derived from 2003 USDA National Nutrient Database for Standard Reference, Release 16. ± 1995 USDA Composition Data.

Don't assume similar products are the same. Be sure to check the Nutrition Facts panel because even similar foods can vary in calories, ingredients, nutrients, and the size and number of servings in a package. Even if you continue to buy the same brand of a product, check the Nutrition Facts panel frequently because ingredients can change at any time.

How Can You Use the Label to Make Heart-Healthy Food Choices?

The Nutrition Facts panel can help you choose foods lower in saturated fat, trans fat, and cholesterol. Compare similar foods and choose the food with the lower combined saturated and trans fats and the lower amount of cholesterol.

Although the updated Nutrition Facts panel will list the amount of trans fat in a product, it will not show a Percent Daily Value (%DV). While scientific reports have confirmed the relationship between trans fat and an increased risk of CHD, none has provided a reference value for trans fat or any other information that the FDA believes is sufficient to establish a Daily Reference Value or a %DV.

There is, however, a %DV shown for saturated fat and cholesterol. To choose foods low in saturated fat and cholesterol, use the general rule of thumb that 5 percent of the Daily Value or less is low and 20 percent or more is high.

You can also use the %DV to make dietary trade-offs with other foods throughout the day. You don't have to give up a favorite food to eat a healthy diet. When a food you like is high in saturated fat or cholesterol, balance it with foods that are low in saturated fat and cholesterol at other times of the day.

Do Dietary Supplements Contain Trans Fat?

Would it surprise you to know that some dietary supplements contain trans fat from partially hydrogenated vegetable oil as well as saturated fat or cholesterol? It's true. As a result of the FDA's new label requirement, if a dietary supplement contains a reportable amount of trans or saturated fat, which is 0.5 gram or more, dietary supplement manufacturers must list the amounts on the Supplement Facts panel. Some dietary supplements that may contain saturated fat, trans fat, and cholesterol include energy and nutrition bars.

Fat Tips

Here are some practical tips you can use every day to keep your consumption of saturated fat, trans fat, and cholesterol low while consuming a nutritionally adequate diet.

Check the Nutrition Facts panel to compare foods because the serving sizes are generally consistent in similar types of foods. Choose foods lower in saturated fat, trans fat, and cholesterol. For saturated fat and cholesterol, keep in mind that 5 percent of the daily value (%DV) or less is low and 20 percent or more is high. (There is no %DV for trans fat.)
Choose alternative fats. Replace saturated and trans fats in your diet with monounsaturated and polyunsaturated fats. These fats do not raise LDL cholesterol levels and have health benefits when eaten in moderation. Sources of monounsaturated fats include olive and canola oils.
Sources of polyunsaturated fats include soybean oil, corn oil, sunflower oil and foods like nuts and fish.
Choose vegetable oils (except coconut and palm kernel oils) and soft margarines (liquid, tub, or spray) more often because the amounts of saturated fat, trans fat, and cholesterol are lower than the amounts in solid shortenings, hard margarines, and animal fats, including butter.
Consider fish. Most fish are lower in saturated fat than meat. Some fish, such as mackerel, sardines, and salmon, contain omega-3 fatty acids, which are being studied to determine if they offer protection against heart disease.
Choose lean meats, such as poultry without the skin and not fried and lean beef and pork, not fried, with visible fat trimmed.
Ask before you order when eating out. A good tip to remember is to ask which fats are being used in the preparation of your food when eating or ordering out.
Watch calories. Don't be fooled! Fats are high in calories. All sources of fat contain 9 calories per gram, making fat the most concentrated source of calories. By comparison, carbohydrates and protein have only 4 calories per gram.

To keep your intake of saturated fat, trans fat, and cholesterol low:

Look at the Nutrition Facts panel when comparing products. Choose foods low in the combined amount of saturated fat and trans fat and low in cholesterol as part of a nutritionally adequate diet.
Substitute alternative fats that are higher in mono- and polyunsaturated fats like olive oil, canola oil, soybean oil, corn oil, and sunflower oil.

Highlights of the Final Rule on Trans Fat

Manufacturers of conventional foods and some dietary supplements will be required to list trans fat on a separate line, immediately under

Food manufacturers have until Jan. 1, 2006, to list trans fat on the nutrition label. The phase-in period minimizes the need for multiple labeling changes, allows small businesses to use current label inventories, and provides economic savings.
FDA's regulatory chemical definition for trans fatty acids is all unsaturated fatty acids that contain one or more isolated (i.e., nonconjugated) double bonds in a trans configuration. Under the agency's definition, conjugated linoleic acid would be excluded from the definition of trans fat.
Dietary supplement manufacturers must also list trans fat on the Supplement Facts panel when their products contain reportable amounts (0.5 gram or more) of trans fat. Examples of dietary supplements with trans fat are energy and nutrition bars.