Project I.M.P.A.C.T.
Patients/Consumers
The National Medical Association wants to promote increased awareness and educate African Americans about clinical trials – what they are, why they are important, and the risks and potential value to participation.
Stop and test your knowledge by taking our Clinical Trial I.Q. Quiz.
A Clinical Trial
A clinical trial is a step-by-step process that studies or tests in humans a new procedure, drug, vaccine, or device. Each trial seeks to answer scientific questions with the goal of finding better ways to prevent, screen for, make diagnoses, or treat a disease. The following is an explanation of the different types of trials.
Prevention trials study approaches, such as medicines, vitamins, minerals, or lifestyle changes that may lower the risk of a disease. These trials look for the best way to prevent a disease or to prevent a disease from coming back.
- Diagnostic trials help determine whether a new screening process or test will contribute to the identification of a specific disease or disorder
- Treatment trials are designed to find more effective treatment approaches and options. They may also involve testing new advances in drug treatment, surgery, radiation treatment or chemotherapy
- Screening trials may be conducted to find out if a screening process (such as for prostate cancer) is useful in detecting the disease at an early stage and, as a result, reduce illness or death from the disease
- Quality of Life trials may study the impact of the disease and the person's ability to do routine activities, with the goal of finding ways to improve a person's comfort of daily living
Participation is Important
Every year thousands of people volunteer for clinical trials that will help them, their families or their communities live happier, longer, healthier lives. Clinical trials depend upon not only researchers, but also on the help of volunteers. To help determine what is best for African American health, we need more African American volunteers.
Volunteers help provide the answers. Without volunteers, there can be no clinical trials.
Why African American Do Not Participate
The reasons often given for why African Americans do not participate in clinical research are:
- Lack of Awareness
- No Access to Healthcare
- The Doctor Didn’t Recommend it
- Fear and/or Distrust
- Cultural Beliefs or Myths
- Racial and Ethnic Discrimination
Why African Americans Should Care
African Americans develop serious illnesses such as hypertension, prostate cancer, diabetes, and AIDS much more often than do other Americans. We suffer more complications and in some instances die earlier from many of these same conditions and diseases. We need to find ways to reduce or eliminate these high rates in our communities. Clinical trials may be part of the answer.
Unfortunately, most treatments are approved without adequate African American participation. In some instances, there are drugs that are approved based on genetics and data from outside the United States. It is expected that we will all react like others - which may not always be true.
Is a Trial Right for You?
Almost no medical treatment, no matter how routine, is completely safe. Even having your appendix out has some small risk of complications. However, having your infected appendix out will save your life and relieve your pain. As a result, it may be worth the small risk associated with the operation.
In the same way, no clinical trial is guaranteed completely safe. There may be some risk of sickness or injury, no matter how small. The key is to choose a trial with a small risk and a big benefit to you. If there is a history of diabetes in your family, you may want to consider joining a diabetes prevention trial. Remember, these trials look for the best way to prevent a disease or to prevent a disease from coming back.
To keep your risks low, you must educate yourself about the particular trial. Ask lots of questions before you decide to join a trial. Talk it over with your doctor, other healthcare provider, family or other trusted individuals.
Sometimes money is offered for you to join a clinical trial. This money can be a subtle kind of pressure, so do not join a trial just to make money! Weigh the possible risks and benefits to you. The decision is YOURS!
What are the Benefits?
- Play an active role in your health care
- Gain access to new research treatments before they are widely available
- Have your health watched very carefully
- Receive most study treatments at no cost to you
- Help others by contributing to medical research
What are Your Risks?
- Potential side effects to medication
- Placebo treatment
- May not work for you
- May have to stop taking other medications
- Time
- Transportation
- Unknown risks
Research Abuses
Some people avoid all clinical trials. They may not know the ways in which a trial can help them or someone close to them. They may not trust researchers because some African Americans were exploited and abused in past medical research. One famous example is the syphilis experiment at Tuskegee, in which hundreds of African American men were studied without their permission and were not treated for their illness.
Abuses in medical research are taken seriously. There are now federal laws in place to protect the volunteer from being taken advantage of in medical research. Today, you must be told all about a clinical trial before you are asked to sign up. This is called informed consent
Informed Consent Process
Informed consent is a process that makes sure every volunteer is told everything he or she needs to know to make a good and independent decision about whether to join a trial.
Informed consent has two parts: being informed, then (maybe) giving consent.
Informed means that the researcher must tell you everything you need to know to make a good decision about whether or not to join a trial. The researcher must tell you about the purpose of the trial and what they expect to happen. This includes all the risks and benefits of joining the study.
Consent means that you must agree to join a clinical trial of your own free will. It is against the law for anyone to pressure you or force you into joining a trial.
Patient Bill of Rights
No matter what you sign, you cannot sign away your legal rights. You cannot be forced to participate in a trial. You can drop out of the trial at any time, regardless of whether or not you have been paid to participate. View the Clinical Trial Participant's Bill of Rights.
Who is Looking Out for You?
- US Dept of Health and Human Services/ Office for Human Research Protection. The Office for Human Research Protections supports strengthens and provides leadership to the nation's system for protecting volunteers in research that is conducted or supported by the U.S. Department of Health and Human Services.
- The Food and Drug Administration/Office of Good Clinical Practice. The Good Clinical Practice Program is the focal point within FDA for Good Clinical Practice issues arising in human research trials regulated by FDA.
- The Institutional Review Board (IRB). An IRB is a group of scientists, doctors, clergy, and consumers whose purpose is to protect study participants. They review and must approve the action plan for every clinical trial. They check to see that the trial is well designed, does not involve undue risks, and includes safeguards for patients.
- The Physician/ Investigator - They are concerned for your health and well-being.
- YOU - Your knowledge of the process.
Questions to Ask & Get Answered
After you and your doctor have decided that a trial might be right for you, the best way to make sure is to learn everything about it you can. This means asking questions - lots of questions. You may feel uncomfortable about questioning the researchers, but remember that it is your health at stake.
Tips
- Buy a notebook just for writing information about the clinical trial.
- Bring a family member with you for moral support and for help in recording what you are told.
Check out a list of questions you should ask and get answered. Bring the list with you to the meeting with the researcher(s) and write down the answers. Also, write down any other questions you think of so that you will not forget them.
Consumer Materials
You’ve Got the Power! PDF and PowerPoint files are available below for free download, viewing and printing .
- What You Should Know About Clinical Trials DVD (9 minute video). Listen to doctors as well as people who participated in clinical trials discuss how important clinical trials are to our community. Get a better understanding of how clinical research affects our lives.
- Powerpoint Presentation - This presentation can be used when speaking to consumer/patient groups.
- Booklet - This booklet provides basic information and a explanation of the clinical trial process. It also has a list of questions for you to discuss with the researcher to make sure that you are making a wise decision.
- Fact Sheet - This fact sheet provides an overview of the clinical trial process. It can be used by patients as a handy reference, or by physicians as a means to educate the public about clinical trials.
- Magnet - This may be placed on your refrigerator to remind you of the importance of participating in clinical trials.
- Bookmark - Use this bookmark as a reminder to you to become involved in clinical trials.
Hard copies of the materials mentioned above are available in bulk. Download the order form (PDF|DOC).