Learn About Your Heart...
Made Simple


By Nicolas Shammas, MD


A new, comprehensive sourcebook for
heart and vascular disease patients

Cardiovascular Health Topics



1.
Statistics about Heart and Blood Vessel Diseases in the United States
2.
Structure and Function of the Heart and Blood Vessels
3.
Diseases of the Blood Vessels of the Heart
4.
Surgical Therapies for the Cardiovascular Patient
5.
Peripheral Vascular Disease
6.
Diseases of the Blood Vessels of the Head and Neck
7.
Strokes: How to Survive Them and How to Prevent Them
8.
Valvular Heart Disease
9.
Heart Rhythms: How to Recognize Them and Treat Them
10.
Congestive Heart Failure
11. Understanding Cardiomyopathy, or Weak Heart Muscle
12. Children and Heart Disease
13. Diseases of the Pericardium
14. Systemic Illnesses, Infections and Drugs that Affect the Heart
15. Erectile Dysfunction: a Vascular Disease
16. Cardiovascular Disease Prevention
17. Heart Healthy Nutritional Tips
18. Cardiac Rehabilitation
19. Medications for Cardiovascular Disorders
20. Heart Tests You Need to Know
21. Learn What to Do in a Medical Emergency
22. How to Choose Your Doctor and Hospital
23. Medical Research and How You Can Get Involved
24. Taking the Next Step — A Few Community Resources to Help You Live More Healthfully
25. How Much Did You Learn from This Book: Take a Simple Test



MEDICAL RESEARCH AND HOW YOU CAN GET INVOLVED

Monica Youngblut, BS, CCRC

What is medical research?

Cardiac research is at the core of new drugs and devices that heart patients use every day. Research conducted by clinical investigators and sponsored by industry, the government, or various organizations has led to tremendous advances in taking care of the heart patient, preventing heart disease, and predicting a person's outcome in the future. Since clinical research is conducted on human subjects, the patient is a critical element in the research process. It is important to recognize the research process and how it is conducted to protect human subjects and their rights.

Medical research (also referred to as a clinical trial or research study) is a systematic approach to test new medications or medical devices to determine if they are safe and effective to use in people. Research studies are also done on drugs or devices that are already approved for use to see if there are new ways to use them. We can also observe the long-term effects of these drugs or devices on people who receive them. A clinical research study always has a question relevant to the care of the patient that needs to be answered, and this is accomplished by conducting the study.

Who decides to conduct a research study?

Certain physicians and researchers (also called clinical investigators or physician-scientists) are actively involved in conducting and supervising the clinical research process. Companies that make drugs and devices conduct studies to have their products approved for use. Valuable information is gained regarding the risks and side effects of the drug or device being tested. This information helps physicians know how to use the drug or device once it is available on the market.

Who approves new drugs or devices to use in the United States?

The Food and Drug Administration (FDA) carefully monitors all clinical trials conducted in the United States. During a trial, the FDA observes for events that may cause harm. They decide at the end of the trial if the drug or device is safe for the general public. If so, it becomes approved and available for physicians to prescribe for their patients.

Who pays for these studies to be done?

Pharmaceutical or device companies, physicians, hospitals, or foundations may fund trials. Federal agencies, such as the National Institutes of Health (NIH) or the Department of Veterans Affairs (VA), also sponsor research studies.

Why is research important for heart patients?

Clinical research has led to major breakthrough discoveries in the treatment of heart disease over the past several years. Improved pacemakers, defibrillators, stents and balloon angioplasty, and a multitude of drugs and devices that heart patients use every day are the results of long years of clinical research. On average, it takes at least 6 to 8 years to get a drug or device approved for marketing. The cost to get just 1 drug or device tested and approved can range from several hundred millions of dollars up to a billion dollars.

Why would I want to participate in a research study?

By participating in a research study, you may have access to newer drugs and devices before they are released to the general public. You also may have more frequent medical care and assessments as part of participating in the trial. The knowledge that the researchers gain from the trial may benefit patients in the future. There is no guarantee, however, that benefit is an end result of a study.

Are there different phases of research trials?

There are 4 different phases of research trials:

  • Phase I trials are the first time a drug or device is used in people. It is often a healthy volunteer who tests the safety and monitors for side effects. Usually, a small number of people are involved (25–75).

  • Phase II trials involve more people (100–200) than Phase I trials. The purpose is to see if the drug or device is safe and effective. These trials are done before the FDA gives approval for general use.

  • Phase III trials further study the effectiveness of the drug or device in large groups of people (1,000–3,000). These studies are also done before the drug or device has been given approval by the FDA. Positive results of these trials typically allow a company to obtain approval for a drug or device to be released to the general public.

  • Phase IV studies are done after a drug or device has been approved and marketed. These studies provide more information about how the drug or device reacts in the general population. It also provides more information on the risks and benefits. There may be thousands of patients involved in Phase IV trials.

What is a research protocol?

A research protocol is like the recipe book for conducting a research study. It contains information about who may be included in the study, what procedure will be done during participation, which medications are involved, and how long people will participate. The protocol is written to ensure that researchers at many different places are conducting the study the same way so results can be looked at together.

What is informed consent?

Informed consent is the process of learning about the specifics of what is involved in participating in a research study. The study doctor or nurse will explain the study, the risks and benefits, the procedures involved, how long the study lasts, and what alternative options are available.This information is also provided as a written document that the patient must sign to be included in the study. Patients receive a signed copy to take home and refer to during the trial.

How do I know my safety is being protected?

Research studies must follow federal regulations designed to protect the safety of patients. Most research studies also need to be reviewed by an institutional review board, a group of people who review and approve a research study. The main purpose of an institutional review board is to protect the safety and welfare of the patients involved in the study.

What is a placebo?

A placebo is a substance that does not have an active ingredient in it that would produce a physical effect. It cannot be used to treat a medical condition. In some research studies, a placebo may be given to 1 group of participants to compare to the group taking the active medication. Researchers are able to compare the placebo group to the treatment group to see if the treatment is beneficial.

What if I am in a clinical trial and decide I want to stop participating?

At any time during a trial you may choose to withdraw. Simply let the research doctor or nurse know you want to discontinue participation in the trial. If possible, let the research staff know your reasons for discontinuing your involvement in the trial.

What kinds of questions should I ask my doctor before deciding to participate in a clinical trial?

You should be informed of all aspects of a clinical trial before you decide to participate. Some of the questions you may want to ask are:

  • Why is the study being done?

  • Why do they believe this treatment will be effective?

  • Which tests or procedures do I need to have done?

  • What are the risks of being in the study?

  • How long will I be involved in the study?

  • Will it cost me anything to participate?

  • Will I be compensated?

  • May I discontinue my involvement at any time?

  • Will I find out the results at the end of the trial?

How can I find out more about participating in a clinical trial?

Ask your doctor if he or she is participating in any research studies for which you may qualify. Check out the Internet for local hospital or clinic websites that conduct clinical trials.


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