Clinical Trial Information For Consumers/Patients
The purpose of Project I.M.P.A.C.T. is to encourage greater participation in clinical trials by minorities, especially African-Americans.
Click on one of the following headings or scroll down to read all the sections:
- Test Your Clinical Trial I.Q.
- Clinical Trial Definition
- African American Participation
- What are My Risks
- Informed Consent Process
- How Am I Protected
- Questions to Ask and Get Answered
- Clinical Trial Video
- Patients Bill of Rights
- Consumer/Patient Education Materials
- Additional Information on Clinical Trials
- Information for Patients
- Share Your Opinion
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
African American 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 on the help of volunteers. To help determine what is best for African American health, we need more African American volunteers. Volunteers provide the answers. Without volunteers, there can be no clinical trials.
Reasons often given for why African Americans do not participate in clinical research:
- 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 heart disease, prostate cancer, diabetes, and AIDS much more often than do other Americans. We suffer more complications and in some instances die earlier from many diseases, such as lung and breast cancer. We need to find ways to reduce or eliminate these high disease rates in our communities. Clinical trials may be part of the answer.
Most treatments are approved without adequate African American participation. There are targeted therapies based on genetics and drugs approved based on data from outside the United States with the expectation that we will react like others - which isn't always true
The National Medical Association wants to promote an increased awareness and educate the public about clinical trials their purpose and value. But not all clinical trials are right for everyone.
Almost no medical treatment, no matter how routine, is completely safe. Even having your appendix out has some small risk of complications. But having your infected appendix out will save your life and relieve your pain and 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. To keep your risks low, you must educate yourself about the particular trial; ask lots of questions talk it over with your healthcare provider and family. Weigh the risks and benefits to you. The decision is Yours!
Potential Benefits to Participating in a Clinical Trial Include:
- Play an active role in your health care.
- Gain access to new research treatments before they are widely available.
- Your health is watched very carefully.
- Most study treatment are at no cost
- Help others by contributing to medical research.
What are My Risks?
- Potential side effects to medication
- Placebo treatment
- May not work for you
- May have to stop taking other medications
- Time
- Transportation
- Unknown risks
Informed Consent Process and Protections
Some people avoid all clinical trials. They may not know the ways in which a trial can help them or someone close to them. Or they may not trust researchers because some black people were exploited and abused in past medical research. One famous example was the syphilis experiment at Tuskegee, in which hundred of black men were studied without their permission and were not treated for their illness.
This episode of abuse was a serious problem, but as a result of the Tuskegee outrage, federal laws now 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 is a process that makes sure that 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 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.
The Consent Form
If you decide to volunteer, you sign a paper called the consent form to indicate that you understand the trial and you want to join it. Be sure to get a copy of the consent form you signed. However, informed consent is a long process, not a piece of paper. No matter what you signed, you cannot sign away your legal rights. You cannot be forced to participate and you can drop out of the trial at any time, whether or not you have been paid to participate.
- Some consent forms are very hard to read and to understand. Many do not give enough details about the clinical trial. Don't be shy or embarrassed about asking questions. In fact, it is smart to ask lots of questions before deciding to join a trial. The researcher should offer you a sheet called a patient information sheet that explains the clinical trial. Take a copy of this home with you to study. Better yet, discuss it with your personal doctor and ask his or her advice about the study
- You should realize that the large amounts of money that are offered to you for joining some clinical trials, especially for trials that may not benefit you directly. This money can be a subtle kind of pressure, so do not join a trial just to make money
- Consent means that you can change your mind and quit the study at any time
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. In relation to Good Clinical Practice, the Good Clinical Practice Program.
- 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
- 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.
Tip- Buy a notebook just for writing information about the clinical trial. Bring a family member with you for moral support and help in recording what you are told.
Click here for 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.