What can research studies tell us?
Research studies can help answer important questions:
Does it work?
- How well does the study medicine work?
- How does the study medicine act in the body?
- Does the study medicine work better than other available medicines?
- How does the study medicine affect certain diseases or conditions?
Is it safe?
- Is the study medicine safe?
- What are the side effects and reactions of the study medicine?
- Are there any differences in the way the study medicine acts due to sex, age, race, ethnicity, or any other factors?
Watch this video to learn more about how clinical trials work.
Reasons why some people
decided to join a trial
Joining a research study is a personal decision, as well as a collective decision. Some people may join because:
- There are no current treatments available or other medications may not have worked. While a participant may benefit from being in a trial, that is not guaranteed, and their condition may stay the same or worsen.
- They want access to specialized care for their condition or disease.
- They want to contribute to medical research that may help future family members, their community and future generations, as Henrietta Lacks has done for so many patients.
Who can join a research study? Everyone!
There are research studies for healthy people, people with a medical condition, and people of all ages and backgrounds.
Babies and
children
Babies and children
Children are not just small adults! Including children in medical research helps to develop medicines and treatments tailored for children.
People who
are pregnant...
People who are pregnant...
...or may become pregnant. When a vaccine or medicine for a lifelong condition is being developed, it’s important to understand how well it will work when a person becomes pregnant. Special rules have been developed to protect pregnant people. Clinical trials must follow strict rules for protecting the health of pregnant people and their unborn babies.
Older adults
Older adults
Even though older adults are a group of people that often need medicines the most, clinical trials are often made up of adults ages 18 to 65. The participation of older adults provides valuable information that is useful for treating those who may need it the most!
Healthy people
Healthy people
A diverse range of healthy volunteers are needed at every stage of medical research! Their participation helps doctors learn about the safety, dosing, and side effects of a new medicine or treatment. Comparing their information with people who have a specific illness or condition helps to answer important questions when developing new treatments. All these factors become more important when we talk about cultural differences.
How does a research study work?
Research studies usually have 3 parts.
During each part, there are usually appointments at the nearest study site, and possibly phone calls or virtual visits.
Screening
You and the study doctor make sure the trial is right for you.
Screening
You and the study doctor make sure the trial is right for you.
Treatment Phase
You take the study medication and have health checks and tests according to a schedule.
Treatment Phase
You take the study medication and have health checks and tests according to a schedule.
Follow-up
After you stop the study medicine, the study team checks on you.
Follow-up
After you stop the study medicine, the study team checks on you.
To go through the
screening
process, you have to agree to join the study by signing the
Informed Consent
Form.
This form is not a contract!
Even if you join, you can leave at any time, for any reason.
Everything that happens during a
research study is
spelled out in a document called a
protocol, which has been reviewed and approved by
regulatory agencies
and
institutional review boards (IRB)
in the countries where the research is taking place.
What is informed consent?
Informed consent is the process of learning about a research study so you get as much information as you need to make your decision about participating in a clinical trial. Asking about a study does not mean you have to join.
- You’ll get information to read about the clinical trial and be able to talk about it with the study doctor and/or another member of the study team.
- You'll have time to think about it and talk it over with family, friends, and possibly a member of the Community Advisory Board (if the research study has one).
- The study team will encourage you to ask any questions you may have.
Ask questions like:
- Why is the study being done?
- Has this drug been tested before?
- What will be expected of me?
- What kinds of procedures/tests are involved?
- Will the study pay me back for anything I have to pay for to be part of the study, like transportation costs?
- If I don’t qualify for a study, can I try again for the same or different study?
- Am I required to finish the study? What if I have an unexpected issue?
- How will I know that the study medication is working?
- What happens after the study?
- Will I be paid for my time?
Learn about the safety requirements involved in a research study and how to make informed decisions when considering participating in one.
