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By participating in clinical research, you can help scientists develop new medications and other strategies to treat and prevent disease. Many effective treatments that are used today, such as chemotherapy, cholesterol-lowering drugs, vaccines, and cognitive-behavioral therapy, would not exist without research participants. Whether you’re healthy or have a medical condition, people of all ages and backgrounds can participate in clinical trials. This article can help you learn more about clinical research, why people choose to participate, and how to get involved in a study.
Mr. Jackson is 73 years old and was just diagnosed with Alzheimer’s disease. He is worried about how it will affect his daily life. Will he forget to take his medicine? Will he forget his favorite memories, like the births of his children or hiking the Appalachian Trail? When Mr. Jackson talked to his doctor about his concerns, she told him about a clinical trial that is testing a possible new Alzheimer’s treatment. But Mr. Jackson has concerns about clinical trials. He does not want to feel like a lab rat or take the chance of getting a treatment that may not work or could make him feel worse. The doctor explained that there are both risks and benefits to being part of a clinical trial, and she talked with Mr. Jackson about research studies — what they are, how they work, and why they need volunteers. This information helped Mr. Jackson feel better about clinical trials. He plans to learn more about how to participate.
Clinical research is the study of health and illness in people. There are two main types of clinical research: observational studies and clinical trials.
Observational studies monitor people in normal settings. Researchers gather information from people and compare changes over time. For example, researchers may ask a group of older adults about their exercise habits and provide monthly memory tests for a year to learn how physical activity is associated with cognitive health. Observational studies do not test a medical intervention, such as a drug or device, but may help identify new treatments or prevention strategies to test in clinical trials.
Clinical trials are research studies that test a medical, surgical, or behavioral intervention in people. These trials are the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device (for example, a pacemaker), is safe and effective in people. Often, a clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.
Other aims of clinical research include:
People volunteer for clinical trials and studies for a variety of reasons, including:
Whatever the motivation, when you choose to participate in a clinical trial, you become a partner in scientific discovery. Participating in research can help future generations lead healthier lives. Major medical breakthroughs could not happen without the generosity of clinical trial participants — young and old, healthy, or diagnosed with a disease.
Looking for clinical trials related to aging and age-related health conditions? Talk to your health care provider and use online resources to:
After you find one or more studies that you are interested in, the next step is for you or your doctor to contact the study research staff and ask questions. You can usually find contact information in the description of the study.
Let your health care provider know if you are thinking about joining a clinical trial. Your provider may want to talk to the research team to make sure the study is safe for you and to help coordinate your care.
Joining a clinical trial is a personal decision with potential benefits and some risks. Learn what happens in a clinical trial and how participant safety is protected. Read and listen to testimonials from people who decided to participate in research.
Here’s what typically happens in a clinical trial or study:
Before a clinical trial is designed and launched, scientists perform laboratory tests and often conduct studies in animals to test a potential intervention’s safety and effectiveness. If these studies show favorable results, the U.S. Food and Drug Administration (FDA) approves the intervention to be tested in humans. Learn more about how the safety of clinical trial participants is protected.
Once a clinical trial or study ends, the researchers analyze the data to determine what the findings mean and to plan the next steps. As a participant, you should be provided information before the study starts about how long it will last, whether you will continue receiving the treatment after the trial ends (if applicable), and how the results of the research will be shared. If you have specific questions about what will happen when the trial or study ends, ask the research coordinator or staff.
Clinical trials of drugs and medical devices advance through several phases to test safety, determine effectiveness, and identify any side effects. The FDA typically requires Phase 1, 2, and 3 trials to be conducted to determine if the drug or device can be approved for further use. If researchers find the intervention to be safe and effective after the first three phases, the FDA approves it for clinical use and continues to monitor its effects.
Each phase has a different purpose:
Clinical trials that test a behavior change, rather than a drug or medical device, advance through similar steps, but behavioral interventions are not regulated by the FDA. Learn more about clinical trials, including the types of trials and the four phases.
Choosing to participate in research is an important personal decision. If you are considering joining a trial or study, get answers to your questions and know your options before you decide. Here are questions you might ask the research team when thinking about participating.
People volunteer for clinical trials and studies for a variety of reasons, including:
Whatever the motivation, when you choose to participate in a clinical trial, you become a partner in scientific discovery. Participating in research can help future generations lead healthier lives. Major medical breakthroughs could not happen without the generosity of clinical trial participants — young and old, healthy, or diagnosed with a disease.
Looking for clinical trials related to aging and age-related health conditions? Talk to your health care provider and use online resources to:
After you find one or more studies that you are interested in, the next step is for you or your doctor to contact the study research staff and ask questions. You can usually find contact information in the description of the study.
Let your health care provider know if you are thinking about joining a clinical trial. Your provider may want to talk to the research team to make sure the study is safe for you and to help coordinate your care.
Joining a clinical trial is a personal decision with potential benefits and some risks. Learn what happens in a clinical trial and how participant safety is protected. Read and listen to testimonials from people who decided to participate in research.
Here’s what typically happens in a clinical trial or study:
Before a clinical trial is designed and launched, scientists perform laboratory tests and often conduct studies in animals to test a potential intervention’s safety and effectiveness. If these studies show favorable results, the U.S. Food and Drug Administration (FDA) approves the intervention to be tested in humans. Learn more about how the safety of clinical trial participants is protected.
Once a clinical trial or study ends, the researchers analyze the data to determine what the findings mean and to plan the next steps. As a participant, you should be provided information before the study starts about how long it will last, whether you will continue receiving the treatment after the trial ends (if applicable), and how the results of the research will be shared. If you have specific questions about what will happen when the trial or study ends, ask the research coordinator or staff.
Clinical trials of drugs and medical devices advance through several phases to test safety, determine effectiveness, and identify any side effects. The FDA typically requires Phase 1, 2, and 3 trials to be conducted to determine if the drug or device can be approved for further use. If researchers find the intervention to be safe and effective after the first three phases, the FDA approves it for clinical use and continues to monitor its effects.
Each phase has a different purpose:
Clinical trials that test a behavior change, rather than a drug or medical device, advance through similar steps, but behavioral interventions are not regulated by the FDA. Learn more about clinical trials, including the types of trials and the four phases.
Choosing to participate in research is an important personal decision. If you are considering joining a trial or study, get answers to your questions and know your options before you decide. Here are questions you might ask the research team when thinking about participating.
When research only includes people with similar backgrounds, the findings may not apply to or benefit a broader population. The results of clinical trials and studies with diverse participants may apply to more people. That’s why research benefits from having participants of different ages, sexes, races, and ethnicities.
Researchers need older adults to participate in clinical research so that scientists can learn more about how new drugs, tests, and other interventions will work for them. Many older adults have health needs that are different from those of younger people. For example, as people age, their bodies may react differently to certain drugs. Older adults may need different dosages of a drug to have the intended result. Also, some drugs may have different side effects in older people than in younger individuals. Having older adults enrolled in clinical trials and studies helps researchers get the information they need to develop the right treatments for this age group.
Researchers know that it may be challenging for some older adults to join a clinical trial or study. For example, if you have multiple health problems, can you participate in research that is looking at only one condition? If you are frail or have a disability, will you be strong enough to participate? If you no longer drive, how can you get to the research site? Talk to the research coordinator or staff about your concerns. The research team may have already thought about some of the potential obstacles and have a plan to make it easier for you to participate.
Read more about diversity in clinical trials.
At Vijaya hospital Nellore Health Care we intend to create medicines that improve both the quality and duration of patient lives.