What are the different types of clinical studies?
Clinical research tests new ways to understand, diagnose, prevent, and treat diseases in humans. Research has led to important discoveries such as new medicines to treat cancer, diabetes, and other diseases making our lives better. Other words for research are clinical trials, surveys, studies, or experiment. This short video from the National Institute for Child Health and Development can tell you more.
There are different types of clinical research including treatment studies, genetic studies, prevention studies, behavioral studies (to understand how and why people behave in different ways).
Clinical research could not be done without the people who agree to take part. Volunteers help researchers find answers to many health questions. Researchers are looking for the best ways to prevent and treat diseases. Research volunteers will be essential to getting answers. There are important questions to ask before signing up for a clinical research study.
To learn more about commonly used the research terms, check out Clinical Trials and You.
What questions should I ask before joining a study?
Members of the research team for any clinical research study should be willing and able to answer your questions. Here are some questions you may want to ask:
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What is the purpose of this study?
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What will I be asked to do?
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Will I be asked to take a new medicine that hasn’t been used before?
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What happens if I don’t get the new medicine or treatment?
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How will my care be different if I decide not to take part in the study?
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How will this study benefit me?
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What risks are involved?
Some research centers have Research Participant Advocates. These advocates help ensure the rights, safety, and well-being of people who take part in research. Their job is to make sure that people get the information they need to know while they are in a research study.
Why would I want to participate in clinical research?
There is no “one size fits all” medical treatment. Doctors need to know how new medical treatments may affect people differently.
Some medical treatments can be affected by certain personal factors. For instance, a person’s sex, age, health status, and genetic makeup affect how they respond to a treatment. That’s why it’s important to have clinical trial volunteers from different backgrounds.
Why are placebos used in research?
Clinical Trials sometimes use placebos. A placebo is a substance or treatment that does not have any real medical effects. A placebo can be a pill, a shot, or device made to look like the real medical product.
Why are placebos used in some clinical trials?
Using a placebo is a way to help researchers see if there is a real effect from a new medical treatment. Sometimes just believing you are getting a real treatment can affect how you think, and this helps you feel better. This is called the placebo effect. Making sure everything that happens in a study is the same for everyone avoids the placebo effect.
Do all clinical trials use placebos?
No. Many trials do not use placebos. The choice to use a placebo depends on many factors. For example, when there are proven treatments for many diseases, the research may compare two real treatments to see which one works best. A placebo might not be used in this type of research.
Are there safeguards to assure placebos are used fairly?
Yes, there are safeguards to assure placebos are used fairly. In many trials that use placebos, neither the doctor nor patient know who gets the real drug and who gets the placebo. This is one way to make sure everyone has an equal chance to get the new treatment. The chances of having a side effect are equal too.
Research has not always helped all people equally. See section on how participants are protected in research to learn more.
What is randomization?
Clinical trials find new and better ways to diagnose, prevent, and treat illness. These studies find out if new medical products really work. They also make sure the products are safe for most people to use. Some clinical trials use randomization.
Randomization means that people are put into groups by chance, not by choice. The groups may be given different types of medical treatments to see which one works best.
Doctors and patients can’t pick which treatment a person gets. Randomization is usually done by a computer. This way of putting people into groups makes sure the groups will be alike on important things like age and health status.
Why not just give everyone the treatment that doctors think will work the best?
Many factors might affect how a person responds to medical treatment. For example, an athlete might be in good shape before starting a medical treatment. The athlete may be given the same medicine as someone who has a lot of health problems. The athlete might get better while the other person does not. The outcome might be due to the athlete’s health before the treatment and not the treatment itself.
Randomization can help make sure the effects of the new treatment are real. The goal is to make sure groups are balanced on factors that might relate to the risk of becoming very sick. If a treatment appears to work, researchers can be more confident that the effects are real.
Is it fair to use randomization in medical research?
Randomization is a way to make sure everyone is treated fairly in research. With randomization, everyone who volunteers for a study has an equal chance of being in each group.
To take a deeper dive into how randomization works and why it’s important, check out this video from the United Kingdom Medical Research Council, or this video from the Office of Human Research Protections.
What is research abuse & what have we learned?
Research abuse means that people who take part in research are intentionally harmed, put at risk, or treated unfairly. This goes against the three golden rules of research to respect people, do no harm, and to be fair.
Before the 1970’s, there was not a way to make sure all researchers followed these rules. Many researchers acted ethically. However, some ignored the safety and well-being of the people who took part in research. These studies were usually approved by the institutions where they took place. In some cases, the research was paid for or run by the U.S. government.
What are some examples of past research abuses?
From 1932 to 1972 a research study, now known as the Tuskegee Syphilis Study, caused harm to black men. Men in this study were not told they had syphilis. They were told they had “bad blood”; a term used for various illnesses. When penicillin was discovered as a cure, they were not given the treatment. This is an example of abuse in research.
Although these men were not injected with syphilis by the researchers, they were denied proper treatment. There have been, however, other cases where researchers exposed people to harmful or infectious substances on purpose. In some cases, this was done to children who were not able to give consent. There have also been past instances of researchers recklessly exposing people to radiation. In many cases, people were not aware and did not give consent.
In other cases, consent was not always freely given. Research was sometimes done with people in prison or in the military. But researchers didn’t always make sure people felt free to refuse to take part. Research abuses were not limited to the United States. Experiments on prisoners in Nazi concentration camps injured or killed many people. Prisoners of war were subjected to medical torture in Japan.
Sadly, there are many more examples of past research abuse. It is important for all researchers to openly acknowledge the past so that similar actions never happen again.
Am I protected from research abuse?
Since Tuskegee, much has changed. There are many safeguards to protect the safety, privacy, and rights of research participants. The U.S. Office of Human Research Protections was established to protect the rights, welfare, and well-being of research participants.
Safeguards include:
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Being in a study is voluntary. People are free to decide if they want to join the study. They can also stop at any time.
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All human research is checked by a group called an Institutional Review Board (IRB). Members of the IRB are not part of the study team. Their job is to protect the rights, safety, and well-being of research volunteers.
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In almost every study, researchers must have informed consent of everyone who takes part in a clinical research study. Informed consent means people are given all the important information about the study before they sign up.
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There are some very limited situations where informed consent may not be required. For example, research may be done for treatment of medical emergencies when the person can’t give consent. However, there are very strict rules about when such research can occur.
Remembering the ways that past research has harmed people can help to prevent such harms from occurring again. But we should not let the errors of the past get in the way of advances for the future. Clinical trials help find safe and effective ways to prevent and treat diseases.
How did Henrietta Lacks change history?
Research has helped make great strides for improving human health. Unfortunately, there are also well-known research abuses that occurred in the past.
The good news is ⎯ researchers have learned from these mistakes. They are now working in new ways to make sure patients and community voices are heard.
How did the story of Henrietta Lacks prompt important changes to how researchers work?
In 1951, Henrietta Lacks was diagnosed with cervical cancer. She was treated at Johns Hopkins Hospital in Baltimore, MD. Her cells were used for research without her consent. It was found that Mrs. Lacks’ cells did not die like most cells in the lab.
Since then, her cells have been used in many different research studies. Countless new medical products were developed based on research with these cells.
In 2010, a book called The Immortal Life of Henrietta Lacks was published. This book told the story of Mrs. Lacks and how this research abuse affected her family.
After the book was published, Johns Hopkins Medicine stated that the institution, “could have — and should have — done more to inform and work with members of Henrietta Lacks’ family out of respect for them, their privacy and their personal interests.”
Since then, Johns Hopkins Medicine has changed many practices. One important change is that members of the Lacks family now have a say in deciding how the cells are used.
How do communities and researchers work together now?
Today, many research institutions work closely with patients and communities. Their input helps scientists understand how the research they do affects people’s lives. Research is guided by the point-of-view of the people the research is intended to help. These relationships are one way to make sure history does not repeat itself. Read section on how participants are protected in research to learn more.