Why Your Participation Matters
While it is known that many illnesses such as sickle cell anemia, asthma, diabetes, heart disease, HIV/AIDS, and certain kinds of cancer affect Blacks more than other people, not much is known about how Blacks respond to certain treatments. In order for scientists to find treatments that effectively treat Black patients, more Black volunteers are needed. Taking part in clinical trials will not only help improve your health but the health of all people.
Clinical Trials Then and Now
In the past clinical trials were mostly conducted on white men, leaving Blacks, women and other minorities out of critical studies. Today, clinical trials are all about inclusion. They welcome and encourage all people to participate. In fact, these closely monitored trials are completely safe and ethical and can provide scientists insight on how to understand health disparities better.
Clinical trials are also more widely registered and available to the public, which allows for transparent results and data that maintains public trust and encourages advancements in clinical trial design.
The pandemic has also caused a shift in how clinical trials work. During the pandemic, clinical trials needed to be registered quickly during COVID-19 and adapted for efficiency and convenience. Now, various methods are being used for recruiting participants online including conducting follow-up meetings online and remotely monitoring the progress of the participants. The pandemic has also allowed for more coordination and collaboration so that the same research isn’t replicated and efforts are made to address gaps in scientific knowledge.
How Are You Protected if You Participate?
Given past scenarios such as the Tuskegee Experiment, this is a valid question for many Blacks. You may be wondering if you will fall victim to the same treatment if you participate. What happens if similar problems arise? Who is making sure that participants are safe? These are some other questions that may be running through your mind.
The good news is, that there are several guidelines to protect you and prevent this from happening. Federal guidelines and codes of ethics are in place to protect clinical research volunteers from harm. In addition, an Institutional Review Board – a panel of professionals and community members – is responsible for monitoring study safety and protecting volunteer rights in every clinical trial.
BEFORE YOU ENROLL
There are several kinds of clinical trials so doing your research beforehand will come in handy. Some clinical trials need healthy volunteers while other clinical trials seek volunteers needing treatment.
Essentially, whether or not a clinical trial is right for you will be based on the following protocol:
- What types of volunteers may enter the study
- The schedules of tests and procedures, study medications and dosages
- Length of the study
- Number of study visits
In some cases, if you don’t fit the above protocol, you may not qualify for the clinical trial.
ONCE YOU QUALIFY
After you qualify for a clinical trial, you will be asked to agree to the above protocol. This process is called informed consent.
BEFORE YOU TAKE PART
Before you officially participate in a clinical trial, it is important to weigh the benefits and risks.
- Getting treatment for an illness when no other treatment exists
- Receiving expert care for your condition
- Having early access to new treatments
- Knowing your participation is helping others
- Not being able to choose your treatment
- Receiving a treatment that may not work as planned
- Experiencing unpleasant or serious side effects
If you want to further weigh the risks and benefits of a clinical trial you are interested in, these questions may help:
- What are the possible side effects or risks of the new treatment?
- What are the possible benefits?
- How do the possible risks and benefits of this trial compare to those of the standard treatment?
Questions to Ask Before Participating
If you’ve weighed the benefits and risks of participating in a clinical trial and still aren’t sure if you should participate, asking your doctors these additional questions may help:
- What is the purpose of this clinical trial?
- Why would researchers think this treatment might work for me?
- What are my treatment options?
- How do you know if you qualify for clinical trials or if it’s right for you?
- When should someone consider participating in clinical trials?
- How will this clinical trial help my family or my community?
- What are the different types of clinical trials?
- What will I be asked to do?
- How long is the clinical trial going to last?
- Do you need insurance to be a part of clinical trials?
- Will I have to pay for any part of the clinical trial, and will I be reimbursed for costs travel, parking, or meals incurred while I am in a clinical trial?
- If the treatment works for me, can I keep using it after the clinical trial ends?
- How will this study affect my daily life?
- Will anyone else know about my participation?
Learn More About Clinical Trials
A clinical trial (also called clinical research) is a research study in human volunteers to answer specific health questions. Clinical trials are the fastest and safest way to find treatments that work and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
Participating in a clinical trial allows you to play a more active role in your health care, gain access to new research treatments before they become widely available and contribute to medical research.
Before joining a clinical trial, you must qualify for the study. All clinical trials use an inclusion/exclusion criteria, which helps produce reliable results. These criteria are based on your age, gender, the type and age of your disease, your previous treatment history and other medical conditions. These criteria aren’t used to exclude anyone. They are used to make sure a clinical trial is appropriate for you and keep you safe. The criteria also help ensure that researchers are able to answer the questions they plan to study. Some research studies are looking for participants with illnesses or conditions, while others require healthy participants.
Informed consent is the best way to get the key facts and information you need about the clinical trial before you decide whether or not to participate. This process will continue to be used throughout the study to provide you with important information. To help you decide, the doctors and nurses that are involved in the trial will explain the details of the study. If your native language isn’t English, you can request translation assistance. Next, the research team will provide you with an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. This is also where you can learn more about the potential risks and benefits of the clinical trial. After reading over the informed consent document, you will then decide whether or not to sign the document. This is not a contract, you can still withdraw from the trial at any time.
Participating in clinical trials that are well-designed and well-executed is the best approach for you to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Help others by contributing to medical research.
However, there are also risks to clinical trials that you should be aware of:
- There may be unpleasant, serious, or even life-threatening side effects to treatment.
- The treatment may not be effective for the participant.
- The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
It is required that experimental treatments are evaluated for both immediate and long-term side effects. These side effects include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. Clinical trials are done under a carefully controlled protocol, which is a study plan that details what researchers will do in the study. These researchers will report the results of the trial at scientific meetings, to medical journals, and to various government agencies as the clinical trial progresses. The names of individual participants will remain secret and will not be mentioned in these reports.
Before participating in a clinical trial, it is important that you know as much information as you can. This includes what care you can expect while in a trial and what the cost of the trial is. The following questions may be helpful to discuss with your health care team. Additionally, some of the answers to these questions are found in the informed consent document:
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the new treatment being tested may be effective?
- Has it been tested before?
- What kinds of tests and treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow-up care is part of this study?
- How will I know that the treatment is working?
- Will results of the trials be provided to me?
- Who will be in charge of my care?
As you prepare to meet with the research coordinator or doctor, it will help to do the following:
- Plan ahead and write down possible questions to ask.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
- Bring a tape recorder to record the discussion to replay later.
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
Yes. It is within your right to leave a clinical trial, at any time. When withdrawing from the trial, you should let the research team know about it, and the reasons why you are leaving the study.
Ideas for clinical trials usually come from researchers. After testing new therapies or procedures in the laboratory and in animal studies, researchers choose the treatments with the most promising laboratory results to be moved into clinical trials. During a trial, researchers are able to gain more information about a new treatment, its risks and how well it may or may not work.
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA). These trials can also take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.
A protocol is a study plan that is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff who will monitor their health and determine the safety and effectiveness of their treatment.
A placebo is an inactive pill, liquid, or powder that has no treatment value. These are often used in clinical trials to be compared with experimental treatments and assess the treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
- Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
- Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Screening trials test the best way to detect certain diseases or health conditions.
- Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illnesses.
Clinical trials are conducted in phases. Each phase of a clinical trial has a different purpose and helps scientists answer different questions:
- In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- In Phase IV trials, post-marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.
Most human use of investigational new drugs takes place in controlled clinical trials conducted to assess safety and efficacy of new drugs. Data from the trials can serve as the basis for the drug marketing application. In some cases, you may not qualify for these carefully-controlled trials because of other health problems, age, or other factors. However, if you may benefit from the drug use but don’t qualify for the trials, you may qualify for a treatment IND (Investigational New Drug application) or treatment protocol.
The primary intent of a treatment IND/protocol is to provide people with a life-threatening or serious disease for which there is no good alternative treatment access to the new drug. A treatment IND/protocol is also used to generate additional information about the drug, especially its safety. Expanded access protocols are managed by the manufacturer, with the investigational treatment administered by researchers or doctors in office-based practice and can only be done if clinical investigators are actively studying the new treatment in well-controlled studies, or all studies have been completed. There must also be evidence that the drug may be an effective treatment in patients who will be treated under the protocol and the drug cannot expose patients to unreasonable risks given the severity of the disease to be treated.