Clinical Trials and Older People 

Tips from the National Institute on Aging

Mr. Jackson is 73 years old and just found 

out that he has 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 taking part in the March on 

Washington with Martin Luther King, Jr.? 

When Mr. Jackson talked to his doctor about 

his concerns, the doctor told him about a 

clinical trial that is testing a possible new 

Alzheimer’s treatment. But Mr. Jackson is not 

sure about this clinical trial business. 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. Dr. Moore 

explained that there are both risks and 

benefits to being part of clinical trials, and 

she talked with Mr. Jackson about these 

studies—what they are, how they work, and 

why they need volunteers. She described the 

ways that participants are protected and 

explained terms like an “Institutional 

Review Board” and “informed consent.” 

Dr. Moore also gave Mr. Jackson some 

questions to ask a clinical trial coordinator 

before agreeing to be part of a clinical trial. 

This information helped Mr. Jackson feel 

better about clinical trials. He plans to learn 

more about how to join a study. 

Like Mr. Jackson, you might have heard of 

clinical trials but may not be sure what they 

are or if you want to join one. Here is some 

information that can help you decide if 

participating in a clinical trial is right for 

you. (The words in bold along with other 

important terms are explained at the end 

of the tip sheet.)

What is a clinical trial? 

A clinical trial is a particular type of research 

study performed in people that is aimed at 

evaluating a medical, surgical, or behavioral 

intervention. 

Most clinical trials test a new treatment, like 

a new drug or diet or medical device (for 

example, a pacemaker) as a method for 

treating a health problem. Often a clinical 

trial is used to learn if a new treatment is 

better and/or has less harmful side effects

than the standard treatment. Other clinical 

trials test ways to find a disease early, sometimes before there are even symptoms. Still 

others test ways to prevent a health problem. 

A clinical trial may also look at how to 

make life better for people living with a 

life-threatening disease or a chronic health 

National Institute on Aging 

National Institutes of health

U.S. Department of Health and Human Services
cLINICAL tRIALS AND oLDER PEOPLE

2

problem. Clinical trials sometimes study 

the role of caregivers or support groups. 

Why would I participate in a 

clinical trial? 

There are many reasons why people choose 

to join a clinical trial. Some join a trial 

because the treatments they have tried for 

their health problem did not work. Others 

participate because there is no treatment 

for their health problem. By being part of a 

clinical trial, participants may find out 

about new treatments before they are 

widely available. Some studies are designed 

for, or include, people who are healthy but 

want to help find ways to prevent a disease 

that may be common in their family. 

Many people say participating in a clinical 

trial is a way to play a more active role in 

their own health care. Other people say 

they want to help researchers learn more 

about certain health problems. Whatever 

the motivation, when you choose to participate in a clinical trial, you become a partner 

in scientific discovery. And, your contribution can help future generations lead 

healthier lives. Major medical breakthroughs 

could not happen without the generosity of 

clinical trial participants—young and old. 

Why do clinical trials need 

older and diverse participants? 

It is important for clinical trials to have 

participants of different ages, sexes, races, 

and ethnicities. When research involves a 

group of people who are similar, the 

findings may not apply to or benefit 

everyone. When clinical trials include 

diverse participants, the study results may 

have a much wider applicability. 

Researchers need the participation of older 

people in their clinical trials so that scientists can learn more about how the new 

drugs, therapies, medical devices, surgical 

procedures, or tests will work for older 

people. Many older people have special 

health needs that are different from those 

of younger people. For example, as people 

age, their bodies may react differently to 

drugs. Older adults may need different 

dosages (or amounts) of a drug to have the 

right result. Also, some drugs may have 

different side effects in older people than 

younger people. Having seniors enrolled in 

drug trials helps researchers get the information they need to develop the right 

treatment for older people. 

Researchers know that it may be hard for 

some older people to join a clinical trial. For 

example, if you have many health problems, 

can you participate in a trial 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 study site? Talk to the

clinical trial coordinator about your concerns. The research team may have already 

thought about some of the obstacles for 

older people and have a plan to make it 

easier for you to take part in the trial.

What are the benefits and 

risks of a clinical trial?

You may ask yourself, “Why should I try 

something that researchers are not sure will 
TIPS FROM THE National Institute on Aging

3

work?” That is a good question. Being part 

of a clinical trial may have risks, but it may 

also have benefits. 

Benefits of a clinical trial: 

z You may get a new treatment for a 

disease before it is available to everyone.

z You play a more active role in your own 

health care.

z Researchers may provide you with 

medical care and more frequent health 

check-ups as part of your treatment.

z You may have the chance to help others 

get a better treatment for their health 

problems in the future. 

Risks of a clinical trial: 

z The new treatment may cause serious 

side effects.

z The new treatment may not work or it 

may not be better than the standard 

treatment. 

z You may NOT be part of the treatment 

group (or experimental group) that gets 

the new treatment—for example, a new 

drug or device. Instead you may be part 

of the control group, which means you 

get the standard treatment or no treatment (a placebo). 

z The clinical trial could inconvenience 

you. For example, medical appointments could take a lot of time or you 

might be required to stay overnight or 

a few days in the hospital.

If I choose to take part in a 

clinical trial, how will my 

safety be protected? 

This is a very important question. The 

history of clinical research is not perfect. 

Based on many years of experience and 

learning, Congress has passed laws to 

protect study participants. Today, every

clinical investigator is required to monitor 

and make sure that every participant is safe. 

These safeguards are an essential part of the 

research. Research abuses like the Tuskegee 

Syphilis Experiment, which began in 1932, 

before safeguards were in place, will NOT 

happen again. 

Researchers are required to follow strict 

rules to make sure that participants are safe. 

These rules are enforced by the Federal 

Government. Each clinical trial also follows 

a careful study plan or protocol that 

describes what the researchers will do. The 

principal investigator, or head researcher, 

is responsible for making sure that the 

protocol is followed. 

An Institutional Review Board, or IRB, at 

each study site must approve every clinical 

trial in the United States. The IRB is made 

up of doctors, scientists, and lay people, like 

yourself, who are dedicated to making sure 

that the study participants are not exposed 

to unnecessary risks. The people on the IRB 

regularly review the study and its results. 

They make sure that risks (or potential 

harm) to participants are as low as possible. 

Along with the IRB, many clinical trials are 

closely supervised by a Data and Safety 

Monitoring Committee. The Committee is 

made up of experts in your condition who 
cLINICAL tRIALS AND oLDER PEOPLE

4

periodically look at the results of the study 

as it is in progress. If they find that the 

experimental treatment is not working or 

is harming participants, they will stop the 

trial right away. 

The informed consent process also helps 

protect participants. Before joining a clinical trial, you will be told what to expect as 

a participant and all the things that might 

happen. For example, someone from the 

research team will explain possible side 

effects or other risks of the treatment. As 

part of the informed consent process, you 

will have a chance to ask questions about 

the trial. The clinical trial coordinator will 

be happy to answer your questions. After 

getting all this information, you can think 

about whether or not you want to participate. If you decide to join the trial, you will 

be given an informed consent form to sign. 

By signing the form, you show that you 

have been told all the details and want to be 

part of the study. The informed consent 

form is NOT a contract. You can leave the 

trial at any time and for any reason without 

being judged or put in a difficult position 

regarding your medical care. 

What questions should I ask 

before deciding if I want to 

take part in a clinical trial?

The following are some questions to ask 

the research team when thinking about a 

clinical trial. Write down any questions you 

might have and bring your list with you 

when you first meet with the research team. 

z What is the purpose of the study? What 

is this study trying to find out?

z What will I have to do as a participant?

z What treatment or tests will I have? 

Will they hurt?

z What are the chances I will get the 

experimental treatment?

z What are the possible risks, side effects, 

and benefits of the study treatment 

compared to my current treatment?

z How will I know if the treatment is 

working? 

z How will you protect my health while I 

am in the study? 

z What happens if my health problem 

gets worse during the study?

z How will the study affect my everyday 

life?

z How long will the clinical trial last? 

z Where will the study take place? Will I 

have to stay in the hospital?

z Will you provide a way for me to get to 

the study site if I need it?

z Will being in the study cost me anything? If so, will I be reimbursed? Will 

my insurance cover my costs?

z Can I take my regular medicines while 

in the trial?

z Who will be in charge of my care while 

I am in the study? Will I be able to see 

my own doctor? 

z Will you follow up on my health after 

the end of the study? 

z Will you tell me the results of the study?

z Whom do I call if I have more questions? 
TIPS FROM THE National Institute on Aging

5

Where can I find a clinical trial? 

There are many ways you can get help to 

find a clinical trial. You can talk to your 

doctor or other health care provider. Or, 

you can search on the National Institutes 

of Health website, www.ClinicalTrials.gov.

Support groups with a focus on a particular 

condition sometimes have lists of clinical 

studies. Also, newspapers in large cities 

may have advertisements for clinical trials 

at nearby hospitals, clinics, or universities. 

If you are interested in learning more about 

clinical research and older people, you may 

want to visit www.NIHSeniorHealth.gov

and look at the “Participating in Clinical 

Trials” topic area. 

What is the next step after I 

find a clinical trial?

Once you find a study that you might want 

to join, contact the clinical trial or study 

coordinator. You can usually find this 

contact information in the description of the 

study. The first step is a screening appointment to see if you qualify to participate. This 

appointment also gives you a chance to ask 

your questions about the study. 

Let your doctor know that you are thinking 

about joining a clinical trial. He or she may 

want to talk to the research team about 

your health to make sure the study is safe 

for you and to coordinate your care while 

you are in the study. 

What are some helpful words 

to know? 

Clinical investigator—a researcher who 

works on a clinical trial. 

Clinical trial coordinator—sometimes 

referred to as the study coordinator or 

clinical research coordinator, this is often 

the title of the person you can contact 

with questions about the study or your 

participation. 

Control group—the group of participants 

who get the placebo or standard treatment 

or no treatment at all. Not all clinical trials 

have a control group.

“Double blind” study—sometimes called 

a masked study, is one in which neither the 

researchers nor the participants know who 

is in the treatment group and who is in the 

control group until the study is over. 

Inclusion and exclusion criteria—the 

factors that researchers use to decide who 

can or cannot take part in the clinical trial. 

Criteria may include age, sex, type and stage 

of the disease, and other health problems. 

Phases—clinical trials are organized by 

four phases or types. Each phase helps 

scientists answer different questions about 

the treatment. The first three phases must 

be completed for a new drug or device to 

be approved by the FDA (U.S. Food and 

Drug Administration). After it has been 

approved for a specific use, the last phase 

of research looks at different uses for a 

drug or device. 

Placebo—a pill or other treatment that 

looks like the treatment or drug being 

tested, but has no medicine in it. A placebo 

is sometimes called a “sugar pill.” Researchers 

may compare what happens to people using 

the experimental treatment with what 

happens to those on the placebo. 
cLINICAL tRIALS AND oLDER PEOPLE

Protocol—the detailed study plan that will 

be followed to answer specific research 

questions and protect participants. The 

protocol describes the criteria for taking 

part in the study, the type of tests that the 

participants will receive, how long the study 

will last, and how researchers will determine 

the benefits and risks. 

Randomized clinical trial—a study in 

which participants are assigned to a 

particular treatment group by chance. The 

researchers and the participants cannot 

choose who is in the control group or the 

treatment group. 

Side effects—undesirable or adverse 

effects caused by a treatment. Examples of 

common side effects are headache, nausea, 

and skin irritation. Sometimes side effects 

can be more serious, even life-threatening. 

Standard treatment—a therapy that is 

effective for a specific disease or condition 

and is currently in wide use. Some studies 

compare a new, experimental treatment to 

a standard treatment to see which is better 

for people. A standard treatment is usually 

one that has been approved by the FDA. 

Treatment group—sometimes called the 

experimental group. These participants will 

get the experimental treatment being tested 

in the clinical trial. Results from the treatment group are compared to those from 

the control group to see if the experimental 

treatment is better and/or safer. 

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SEPTEMBER 2009

NIH PUBLICATION No. 09-7470

For more information about health and aging, contact:

National Institute on Aging 

Information Center

P.O. Box 8057

Gaithersburg, MD 20898-8057

1-800-222-2225 (toll-free)

1-800-222-4225 (TTY/toll-free)

www.nia.nih.gov

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