Brochure - under represented population version

Help us discover Be part of Clinical Research at Yale

“Yale excels at scientific discovery. But we need your help in transforming what we discover in the laboratory into new therapies. Without volunteers willing to participate in clinical studies, the medicines your family uses every day wouldn’t exist.”

Robert J. Alpern, MD Dean, Yale School of MedicineEnsign Professor of Medicine

The Yale SChool of MediCine haS a STRong TRadiTion of developing pRoMiSing new TReaTMenTS.

The insulin pump used in treating diabetes, medications to treat hiv infection, and the first therapy

that arms the body’s cells to create a cancer-fighting immune response were all developed here.

discoveries like these involve years of pathbreaking research and scientific collaboration. But they also

require the help of people like you, because in order to bring these discoveries to patients, we must first

test them in clinical trials.

TiMeline

This timeline shows the many medicines and treatments developed at Yale that have been used to improve

the health of people around the world. all these therapies were made possible because volunteers took

part in clinical studies. without their participation, we would never know whether these treatments work.

Your participation makes it possible to continue Yale’s tradition of medical breakthroughs.

1896 1942 1946 1947 1949 1957 1958 1959 1960

arthur wright, a Yale physicist, produces the first X-ray image in the United States.

develops the first artificial heartpump in the United States.

The first U.S. hospital to introduce natural childbirth as a general service for all obstetrical patients.

first hospital to use fetal heart monitoring.

discovery of the sleep hormone melatonin.

first antiviral drug developed.

world’s first newborn intensive care unit.

introduction of life-savingpenicillin in the United States.

The first use of chemotherapy to treat cancer in the United States.

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Yale-new haven hospital opens the first rheumaticfever-cardiac clinic, one of the nation’s earliest regional heart centers.

first U.S. hospital to allowhealthy newborns to stayin rooms with their mothers.

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1896 1942 1946 1947 1949 1957 1958 1959 1960 1966 1972 1975 1978 1979 1980 1985 1994 1997 2010

The phrenic nerve pacemakerallows quadriplegics tobreathe without a respirator.

first U.S. hospital-based newborn screening program for sickle cell anemia.

The first genetically modifiedmouse; such mice are now used in the early stages of research todevelop disease treatments.

The fda approves Zerit, an hiv drug that is part of the three-drug “cocktail” extending the lives of many thousands of people with hiv/aidS worldwide.

first use ofhigh-throughputdna sequencing todiagnose disease.

first fetal cardiovascularcenter in the United States.

lyme disease identified and named.

The fda approves timolol totreat glaucoma; it is the firsteffective therapy for thedisease since the early 1900s.

first insulin infusion pump for diabetes.

discovery of the mechanism of protein folding—a step toward understanding such neurodegenerative conditions as alzheimer’s disease.

first documented heart transplants in adult identical twins—one in 1992, the second in 1997.

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David J. Leffell, MD Deputy Dean for Clinical Affairs for the Yale School of Medicine, CEO of Yale Medical Group

“Being at the cutting edge of medicine means providing the best possible clinical care alongside innovative clinical research. That’s how we’re able to turn the latest medical discoveries into medical advances that help patients. But we need volunteers to help us do that.”

whaT iS a CliniCal TRial?

a clinical trial is any test or study that involves human volunteers. every clinical trial is designed to

answer specific questions about possible ways to prevent, diagnose or treat a disease or injury.

aT Yale, TheRe aRe hUndRedS of CliniCal STUdieS UndeRwaY foR a wide vaRieTY of CondiTionS.

Some trials need volunteers with a particular illness or condition. There are also many trials that

require healthy volunteers. healthy participants are often needed to provide information that can be

compared with that from people who have a specific illness or condition, and to help establish the

safety, dosage, and side effects of a new drug or treatment. all these research studies are an important

and necessary step in the process of making sure new treatments are safe and effective. They also

offer an opportunity for the volunteers who participate in them to try new or experimental treatment

options; help bring new medicines to patients who need them; and make valuable contributions to the

advancement of medical knowledge.

if you’re interested in learning more, experts are available to help you find a clinical trial that’s

best suited to you; explain what’s involved; and guide you through the process of enrolling and

participating in a research study.

Please visit our website, www.yalestudies.org, where you can review available trials and build

your personal profile. Or call 1-877-y-studies (97883437) for more information.

whY do people paRTiCipaTe in CliniCal TRialS?

There are many reasons why people volunteer to take part in a clinical trial:

• Some volunteers have a condition that is being treated effectively but they want to help doctors find

out more about it in order to develop new treatments.

• Sometimes volunteers have a friend or loved one with an illness or injury and they want to participate

in a research study as a way to help that person and others who may suffer from the same condition.

• It may be that there is no effective treatment for an illness or injury, or that the existing treatment has

harsh side effects. participating in a clinical trial may offer potential experimental options that might

be unavailable otherwise.

• Many people choose to participate in a study even though it might not help them directly. Knowing

that others may benefit from their efforts is a rewarding experience.

• Sometimes people volunteer because they are compensated financially for their time and effort.

every clinical trial includes guidelines about eligibility to participate. The guidelines are based on

such factors as your age, gender, whether you have a certain disease, and your previous treatment or

medical history.

Some of the ways to determine whether a clinical trial is right for you include:

• Comparing the reason why you’re interested in participating to the question the trial hopes to answer.

You should think about whether the trial has the potential to fulfill your hopes and expectations.

You should also weigh the potential risks and benefits of participating in the trial.

• Informing yourself about the questions the trial is trying to answer by doing your own research on

reputable websites and in the library, and by asking questions. You may also want to talk to your

family, friends, or your personal physician.

YCCi staff members, study doctors, nurses, and coordinators are available to answer your questions so

that you can make an informed decision.

How do I Know a ClInICal trIal IS rIgHt for Me?

It’s surprising how many ordinary people have helped make extraordinary discoveries.


It’s surprising how many ordinary people have helped make extraordinary discoveries.

each of us benefits every day from clinical research. Your blood pressure medicine, your child’s asthma

inhaler, the latest antidepressant medication that your friend is taking – all these are available to

you because of clinical studies that show they are safe and effective. none of them would be possible

without volunteers willing to take part in clinical studies.

hundreds of potentially life-saving treatments may never get to those who need them without your

help. help make a difference by volunteering for a clinical trial.



You can help those whose work is helping millions.whaT happenS dURing a CliniCal TRial?

The clinical trial team includes a doctor, research nurses, and such other staff as study coordinators

and technicians. They will guide you through the process of enrolling and participating in the study

and will also be able to answer your questions about the trial. Trials may involve:

• testing new drugs, devices, or treatments

• Questions about your health history

• analyzing such biological specimens as blood

• Using such diagnostic techniques as imaging scans to learn about a condition or treatment

Some trials require an overnight stay in the hospital, but many involve only clinic or office visits.

The clinical trial team will explain exactly what’s involved before you enroll in a study.

You can help those whose work is helping millions.whaT ShoUld i ConSideR BefoRe agReeing To paRTiCipaTe in a TRial?

You should know as much as possible about the trial and feel comfortable asking the research team

any questions about what’s involved. The following questions may be helpful:

• what is the purpose of the trial and how long will it last?

• what drugs, devices, procedures, tests, examinations, or visits are required in order to participate?

• will I have to change my daily activities or diet if I participate?

• what are the standard treatment options for my condition if I choose not to participate?

• whom should I contact if I have questions about the trial?

It gave me more options and a better outlook possibly on the future. Kathy - Cancer trial volunteer“ ”

“We’ve made tremendous strides in treating cancer. Patients are living longer and enjoying a higher quality of life. That’s been possible because every single drug used to treat cancer was tested in clinical trials.”

Thomas J. Lynch, MD Director, Yale Cancer Center Physician-in-Chief, Smilow Cancer Hospital at Yale-New Haven Hospital

do i need To have an illneSS To paRTiCipaTe in a CliniCal TRial?

no, you don’t have to have a specific illness or condition to participate in a clinical trial. in fact, there

are many trials that need healthy volunteers. participants who are healthy are often needed to provide

information that can be compared with that from people who have a particular disease.

a clinical trial may offer a new or experimental treatment that may not otherwise be available to you.

in some cases this therapy may be more effective than the standard treatment for a particular illness,

although there’s no way of knowing this in advance. Clinical trials are a treatment option for many

people with cancer. Based on the questions the research is trying to answer, each clinical trial has

guidelines on who may or may not join the trial. These guidelines help ensure your safety and the

accuracy of the study’s results. if you have cancer or another illness, you should discuss with your

doctor whether participation in a clinical trial is right for you.

will i ReCeive a plaCeBo?

wHat If I Have an IllneSS lIKe CanCer? ShoUld i paRTiCipaTe in a CliniCal TRial?

a placebo is a substance designed to look like the medicine being tested, but it is not active. placebos are

almost never used in cancer treatment trials. in some cases, a study may compare standard treatment

plus a new treatment, to standard treatment plus a placebo. You will be told if the study uses a placebo.

“I work in clinical research but I’m also a parent. I want to know that the medicines I give my son are safe and effective. The best way to find that out is through clinical research.”

Tesheia Johnson, MBA, MHS Associate Director for Clinical Research, Yale School of Medicine Chief Operations Officer, Yale Center for Clinical Investigation

whaT aBoUT ChildRen’S paRTiCipaTion in CliniCal TRialS?

Children are not small adults. it’s important to include them in clinical trials to make sure medications

are safe for young patients and to determine the proper dosage of these drugs. Researchers are careful

to design child-friendly studies of short duration that make it as easy and comfortable as possible for

young patients and their families to participate.

whY do ReSeaRCh in ChildRen?

how ShoUld i pRepaRe To MeeT The ReSeaRCh CooRdinaToR oR doCToR To diSCUSS paRTiCipaTing in a CliniCal TRial?

parents want to know that the medicines they give their children are safe and effective. Medicines,

devices, and treatments, however, are often not tested in children. Children are given a medication in

nearly half of medical visits — but 70% of those medicines have been tested only in adults. if children

don’t participate in clinical research, we have no way of knowing how their bodies handle medicines

and other treatments over time.

• write down any questions you may have ahead of time.

• ask a friend or relative to come along for support and to hear the responses to your questions.

• Bring a tape recorder and record the discussion so you can listen to it again later.

not all dISeaSeS are Created eQUal.

MinoRiTieS have higheR RaTeS of CeRTain diSeaSeS.

it is an unfortunate fact that minorities suffer disproportionately from such diseases as cancer, diabetes,

cardiovascular disease, and hiv. The fastest and safest way to determine whether new treatments

work for these and other diseases is through clinical research. Yet it’s often difficult to find volunteers

– especially minorities – willing to participate in clinical trials. There is a shortage of participants in

clinical research—and minority participation is even lower than that of the general population.

iT’S iMpoRTanT To inClUde all TYpeS of people in CliniCal STUdieS.

human beings are very much alike. only one-tenth of one percent of our genes varies from one person

to the next. But even with these tiny differences, there are still people with different appearances and

different health conditions. illnesses affect each of us differently – as individuals, as families, as racial

and ethnic groups, and as communities. Because of these differences, it’s important to study different

groups of people in order to understand what treatments work best for them. The best way to know

that a particular medicine is right for someone is to test it in similar people.

Many diseases affect african americans more than people from other groups. for example:

• african americans are more likely to have stomach cancer than other groups. Men have higher rates

of lung and prostate cancer. Breast cancer is more common in african american women under 45,

and they are more likely to die from this disease than other women.

• african americans are twice as likely as non-Hispanic white adults to be diagnosed with diabetes.

They are also more likely to have kidney disease; to be hospitalized; and to die from diabetes.

• african americans have higher rates of high blood pressure. Men are more likely to die from heart

disease. women are more likely to be obese.

• african american infants are almost four times as likely to die from causes related to low birth weight

compared to non-hispanic white infants.

• african americans are more likely than white adults to have a stroke. Men are 60% more likely to die

from it. Survivors are more likely to become disabled and have difficulty with daily activities.

“We support clinical research at Yale because it helps our community.”

Rev. Dr. LeRoy O. Perry, Jr. (left)Pastor, Mount Olive AME Zion Church andCultural Ambassador to the Yale Clinical Research Program

Rev. Timothy Howard (right)Presiding Elder, Western District AME Zion Churchand Cultural Ambassador to the Yale Clinical Research Program

we want to MaKe a dIfferenCe

Yale is committed to developing treatments to lower the toll of chronic disease.

Together with the african Methodist episcopal (aMe) Zion Church, we are working to ensure

that clinical studies meet the community’s needs. The aMe Zion Church is one of the nation’s

oldest african american denominations. Representatives of the aMe Zion Church serve as cultural

ambassadors to Yale’s research programs. They act as expert resources, advising Yale investigators

how best to raise awareness about clinical research. Together, Yale and the aMe Zion Church are

educating the community about how disease affects its members and the importance of participating

in clinical research.

we are dedicated to finding new ways of treating disease in all types of people, including men,

women, children, the elderly, and minorities. But we need your help. By volunteering for clinical

research, you can play an important role in helping us discover the medicines of tomorrow.

whaT’S iMpoRTanT To YoU

Hundreds of future life-saving treatments could depend on you.

Rev. Eldren MorrisonPastor, Varick Memorial AME Zion Church and Cultural Ambassador to the Yale Clinical Research Program

everyone cares about their health, regardless of their educational level, how much money they have,

what language they speak, or where they live. if you are a member of a minority group, however, what’s

important to you—or what concerns you—may be different from what’s important to someone else.

• Some people find it hard to ask questions of medical providers.

• others may be concerned that research means “experimenting,” or that doctors and nurses doing

research care only about using people for their own purposes.

• Some may have had a bad experience in the hospital or clinic, and think something bad could

happen to them if they participate in a clinical trial.

• a lot of people have problems understanding the words or ideas in the long consent forms they

must sign for a study.

• others may be uncomfortable with a study team that is “different” from them or doesn’t speak

their language.

• Some people may not know what a clinical study is.

whaT YoU ShoUld do

You may wish to talk with your family or friends about joining a clinical study. You should also do

your homework and gather information. Reach out to others who may help you make decisions. Bring

family members or friends with you to talk about the study. There are community advocates who can

help you understand the role of the research study and what it means for you and your family.

I did it not only for myself but for future patients. It’s a few days out of my life that could change someone else’s life. Stephanie - endocrinology trial volunteer“ ”

Hundreds of future life-saving treatments could depend on you.

Dr. William Tamborlane examining a young participant.

If I participate in a research study, I won’t get real medicine. Clinical studies will often compare one treatment that is known to be effective in treating a disease

with another treatment that may be more effective. Some studies involve a placebo – sometimes called

a “sugar pill” – that is not active. You will always be told if a placebo is used in a study. placebos are

almost never used in studies for cancer. for other diseases, standard treatment plus a new treatment

may be compared to standard treatment plus a placebo. either way, you are getting real medicine.

The researchers can do whatever they want. I’m just a guinea pig. like all health care providers, the study team conducting research must follow rules and laws that

protect your safety. Many of these are mandated by the federal government. every clinical trial in the

United States is approved and monitored by a committee whose job is to ensure your safety. at Yale,

these committees are part of the human Research protection program, which ensures that Yale studies

are conducted ethically. all trials also follow a study plan that states exactly what researchers will do in

the study.

I’m not sick. Why should I take a chance and jeopardize my health? There are many studies that need healthy volunteers to compare with those who have a certain medical

condition. These studies usually involve lifestyle interventions or behavioral change. Sometimes these

programs have the potential to benefit you. other studies merely collect information by way of a

questionnaire. These kinds of studies are an opportunity to help your community at little or no risk

to you.

When I’m sick, I use remedies that have been in my family for years. I don’t need to spend a lot of time and money seeing a doctor. Many people depend on home remedies to help them feel better when they’re sick. others have had

positive experiences with natural or herbal remedies. But if you rely solely on home or natural remedies,

you could be missing out on proven medical treatments that have helped millions of people. we know

those treatments work and that they are safe because they’ve been tested in clinical trials.

My faith will see me through when I’m sick. Research shows that faith plays an important role in healing disease. There are also many medical

treatments available to keep you healthy and extend your life. we can develop new ones only by

carefully testing them to make sure they are safe and effective. That’s why clinical trials are important

to the health of you and your family.

addReSSing CoMMon BeliefS

Medical research changes lives. You can change the course of medical research.

Scientists and doctors at Yale are working hard to bring you new medical treatments. They are

tirelessly looking for novel therapies to treat disease. But they can’t do it without your help. They need

volunteers for clinical research to help bring discoveries from the laboratory to people who need them.

The medicines that you and your family regularly use are at your disposal thanks to those who have

participated in clinical research. we hope you’ll be one of them.

hundreds of potentially life-saving treatments may never get to people who need them without your

help. help make a difference by volunteering for a clinical trial.



Medical research changes lives. You can change the course of medical research.


Sandra Alfano, PharmD, FASHP, CIP Acting Director, Human Research Protection Program

“My job is to protect you and to make sure that clinical trials at Yale are as safe as possible for those who participate.”

Yale’s human Research protection program is responsible for making certain that Yale studies maintain

the highest ethical standards for protecting volunteers. The ethical and legal codes that govern medical

practice also apply to clinical trials. Most clinical research is regulated by the federal government with

built-in safeguards to protect participants. for example, every clinical trial in the United States must

be approved and monitored by an independent committee of physicians, community advocates, and

others to make sure the rights of study participants are protected. This committee ensures that the risks

are as low as possible and that potential benefits are worthwhile.

Besides undergoing a thorough review, all trials follow a carefully controlled study plan that details

what researchers will do during the study. as a clinical trial progresses, researchers report the results

of the trial at scientific meetings, to medical journals, and to various government agencies. individual

participants’ names remain secret and are not mentioned in these reports.

how iS MY SafeTY pRoTeCTed?

aRe TheRe SpeCial pRoTeCTionS foR ReSeaRCh involving ChildRen and oTheR vUlneRaBle people?

Yes. Special protections for children are included in the government rules that protect those who

participate in clinical research. also, doctors, nurses, and other experts carefully review each study

in detail before a single child is enrolled. These protections also extend to such other vulnerable

participants as pregnant women, the elderly, and those who are mentally impaired.

(Above) Dr. Robert Sherwin with a patient in a diabetes study.

Real People Who Are Helping Us Discover

“Clinical studies can be an opportunity to find out and learn about yourself.”

Curtis PattonLifestyle Interventions and Independence for Elders (LIFE) Study

(Above) Curtis Patton with Dr. Thomas Gill, leader of the LIFE study.


MainTaining oldeR adUlTS’ independenCe

at 76, Curtis patton had the usual ailments of a person his age. So when he received a letter in the mail

encouraging him to participate in a clinical trial for older adults, he was intrigued.

The study, lifestyle interventions and independence for elders (life), was designed to prevent

or delay mobility disability – the inability to walk a quarter of a mile – in adults aged 70 to 89.

participants were randomly assigned to either a physical activity program or a series of workshops

focused on strategies related to prevention and health promotion. The study aims to change how older

people live, teaching them lifestyle practices that can help them maintain their independence.

led by Thomas gill, Md, the study is being conducted through Yale’s program on aging. This

program offers several clinical trials that evaluate the factors that play a role in aging and test

interventions to increase older adults’ independence and quality of life.

like most of the other life participants, patton believes the study has been beneficial to him, giving

him the tools to negotiate his life as he gets older. he also recognizes that clinical research has the

potential to benefit many others, including his family, the community, and the nation.

The Rosenfield family

Amy RosenfieldDaughter Hannah ( far left) participated in a diabetes trial

“Clinical research is really important and it’s the only way things are going to change. Look at the diseases research has eradicated. Maybe diabetes could be the next one – but it will never happen if there’s no research.”


(Above) Rachel Rosenfield has blood drawn as part of a clinical trial to prevent and treat type 1 diabetes.

TReaTing and pRevenTing diaBeTeS

when hannah Rosenfield was diagnosed with type 1 diabetes at age 10, her mother amy immediately

looked beyond the standard treatment for something that might benefit her daughter long term. amy’s

search led her to a clinical trial at Yale for those newly diagnosed with type 1 diabetes, sometimes called

juvenile-onset diabetes. within weeks of her diagnosis, hannah was enrolled in the two-year study.

hannah responded well to the experimental treatment. almost four years after her diagnosis, she was

still producing small amounts of insulin. hannah also participated in a follow-up study to find out the

longer-term effects of the new drug she had taken.

hannah’s three siblings have participated in a clinical trial for relatives of type 1 diabetes patients—part

of a series to prevent and treat the disease in its early stages. Knowing whether their other children are at

risk for developing diabetes has given hannah’s parents peace of mind.

for the Rosenfields, participating in clinical trials has offered both hope and encouragement. They know

they’ve done everything possible not just for hannah and her siblings but also for countless others who

suffer from diabetes.


“As a researcher, I’m proud to lead Yale’s clinical research program and play a role in developing new treatments. As a doctor, I see first hand how those treatments benefit my patients.”

Robert Sherwin, MDC.N.H. Long Professor of Medicine Director, Yale Center for Clinical Investigation

Yale iS CoMMiTTed To iMpRoving The healTh of paTienTS in new haven and aRoUnd The woRld.

The Yale Center for Clinical investigation (YCCi) was launched in 2006 to promote clinical and

translational research and to train the next generation of investigators to develop therapies that will

make our lives better. YCCi was one of the first 12 centers to be funded by the national institutes of

health as part of an initiative to bring medical research from the laboratory to patients.

YCCi is headed by Robert Sherwin, Md, a world-renowned physician scientist who is a leader in

diabetes research. in 1979, he developed the insulin pump with william Tamborlane, Md, who is

now YCCi’s deputy director for clinical research. Today, the insulin pump is used by hundreds of

thousands of diabetes patients.

innovative research that leads to the discoveries of treatments like these is the reason YCCi was

established. By providing scientists and doctors with the tools they need to conduct pioneering

research, YCCi aims to bring medical advances to patients who need them. You can help us by

volunteering for clinical research.

To find out more about clinical trials at Yale,

visit our website, www.yalestudies.org.

or call 1-877-y-studies (97883437)

for more information.

Documents

Brochure - under represented population version