GRAAHI will work to advance understanding of the development and the progression of disease as they contribute to health disparities.
Research aids in determining the effects of medication and certain treatment procedures on health issues. Current research is also being used to determine best practices for treatment and care for consumers. Low participation from African Americans and other minorities is seen throughout the United States in research studies. African Americans have the highest health disparities yet have one of the lowest participation rates. Best practices for health care in African Americans cannot be determined without their participation.
What are the barriers to participation?
Most of those barriers preventing participation involve; mistrust, fear, lack of knowledge about research, poor access to primary medical care, communication difficulties, limited minority health professionals and economic barriers such as time off from work and transportation.
The Tuskegee Syphilis Study has left a legacy of fear and mistrust of research studies. Today there are many types of research studies and a greater amount of protection in place to protect those that participate. Some studies collect only data and do not require any medications or treatment procedures. GRAAHI encourages all African Americans to become better educated about research studies so they can make more informed choices on participating and protect themselves at a higher level when participating. Please see the Research Information page for further information on research studies.
Future generations depend greatly on the actions of the current generation. Help to brighten that future and decrease those health disparities faced by the African American community.
Making decisions to become involved in research is easier made when informed about the different aspects of research. Listed below is a variety of information on research to help you understand what research is. Please review this information and check out those sites that list current research studies. A list of questions are available if you do choose to participate, so that you can ask the right questions during the informed consent process.
Types of Research:
- Clinical trials – studies that measure the effectiveness and safety of treatments or interventions, such as drugs or treatment programs.
- Epidemiologic studies – studies that look at the percentage of people who are affected by a particular disease or occurrence.
- Meta-analyses – studies that combine the results of individual studies to get an overall view of the effectiveness of a treatment.
- Registry – an organized system for the collection, storage, retrieval, analysis, and dissemination of information on individual persons who have either a particular disease, condition (e.g., a risk factor) that predisposes to the occurrence of a health-related event, or prior exposure to substances (or circumstances) known or suspected to cause adverse health effects. Source: www.ncvhs.hhs.gov/9701138b.htm. Please see this web site for further information on registries.
Types of Studies:
- Laboratory experiments – studies of animals, living tissue, cells, and disease-causing agents.
- Epidemiologic studies – search for risk factors, or predictors of diseases.
- Controlled clinical trails – studies that compare an experimental group with a control group.
Types of Study Designs:
- Randomized controlled trail – testing a drug or some other treatment by comparing at least 2 groups: an experimental group that is being tested and control group that is observed for comparison; often the studies are double-blind, so that the researchers and the participants do not know the treatment assignments; considered the best type of scientific research to determine effective treatments. (This type of design is described in further detail below)
- Crossover Trial – participants receive 2 or more treatments 1 after the other and act as their own controls for comparison of drug treatments.
- Cohort Study – follows a group of people over time to determine who develops a disease or other outcome; can be prospective (the outcome studied has not occurred yet) or retrospective (information is collected after the outcome has occurred).
- Case-controlled study – retrospective study in which participants with a disease (cases) are compared with those who do not have the disease (controls) to study risk factors for the disease.
- Cross-sectional study – studying a group of people at a given point or period of time; can be used to determine if variables are associated with each other but cannot be used to determine cause
- Case series – describes the characteristics of a group of patients with a particular medical condition or patients who have undergone a particular medical procedure.
- Meta-analysis – systematic review of studies that pools the results of 2 or more studies to obtain the answer to an overall question of interest.
- Cost-effectiveness analysis – compares the benefits of a treatment with monetary costs.
Randomized Controlled Clinical Trails:
Randomized controlled clinical trails are the best way to objectively assess treatments. Elements of these trials include:
- Informed consent – potential participants are informed about the key facts and procedures of the study and then decide whether or not to give their consent to participate in the study.
- Randomization – participants receive treatment in the study by random assignment, somewhat like flipping a coin – each participant has an equal chance of being in the treatment group or being in the control group. This assures that differences in outcomes are due to the treatments alone and not other factors.
- Control group – the control group is used to measure the effectiveness of the treatment by comparison with the group randomized to receive a treatment (the “treatment group”). The control group may receive a standard treatment while the treatment group receives a new treatment, or in some studies people in the control group receive an inactive substitute (for example, a pill with no pharmaceutical effects) for the treatment called a placebo.
- Blinding – in most studies the participants do knot know whether they have been randomized to the treatment or the control group; this is referred to as “blinding.” Studies in which neither the participants nor researcher know who has been randomized to which group until the end of the study are called “double-blind” studies. This is the most objective way to assess the treatments.
Phases of Treatment Trials:
- Phase 1 trials are conducted to determine if a new treatment is safe and what doses can be given and discover the main adverse effects of the new treatment. At this first phase, a small number of patients are enrolled.
- Phase 2 trials further evaluate the safety and potential effectiveness of a therapy and evaluate how it affects the body.
- Phase 3 trials provide scientific testing of the value of a new treatment. Participants are randomly (by chance, like flipping a coin) assigned to receive the new therapy, the current standard therapy, or a placebo (an inactive pill or procedure). (See information on randomized controlled clinical trials). Most new therapies move on to phase 3 trials only if they have shown promise during phase 1 and phase 2 trials.
- Phase 4 trials evaluate the long-term safety of the new treatment and takes place after the treatment has been approved for use.
Eligibility to Participate in a Clinical Trial:
Every clinical trial has guidelines that outline who can and cannot participate in the study. These guidelines are called eligibility criteria. Cancer clinical trials for example, usually require that patients have a particular type or stage of cancer to participate.
Patients who wish to enroll in a clinical trail must give informed consent before participating. Informed consent ensures that patients understand the potential risks and benefits of joining a clinical trial prior to participating. During the informed consent process, participants are told about what the trial involves and the purpose of the study. Participants sign an informed consent form to acknowledge that they understand the risks and benefits of the study, but the form is not binding, and participants can leave the study at any time for any reason. (See information on what questions to ask during the informed consent process).
Benefits of participating in a clinical trial:
- Participants may receive promising new therapies that are not available to the public.
- Participants are closely monitored by researchers, doctors, and other health care professionals during the clinical trial.
- Results from the clinical trial may help other patients in the future.
- Providing results from a population who has not been included in research in the past.
Risks of participating in a clinical trial:
- New therapies are not always better than standard treatments with which they are compared.
- New treatments may have unexpected adverse effects or risks.
- Participants in randomized trials may not receive the therapy they want.
- Health insurance may not cover all of the costs associated with participating in a clinical trial. Disclosure about any costs should be party of the informed consent.
The above information is provided by the JAMA Patient Page. Further information can be found at www.jama.com.
Current clinical trials or studies:
Having a list of questions to ask prior to meeting with or talking by phone to those involved in the clinical trial will help you in getting the answers you need to feel comfortable in being a participate in a study.
What questions should I ask during the informed consent process or when considering participating in a research study?
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment/drug being tested may be effective?
- Has it been tested before?
- Will the study directly benefit me?
- Will the study benefit others?
- Are there risks? If so, what are they and what are the chances that they will occur?
- What discomforts are involved?
- How long will the trial last and what is my time commitment?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- Who will be in charge of my care?
- What should I do if I want to drop out of the study?
- May I get back to you after I discuss this with my family/friend/case manager/doctor?