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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 1966

Arthur Wright, a Yale physicist, produces the first X-ray image in the United States.

Development of the first artificial heart pump in the United States.

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

The phrenic nerve pacemakerallows quadriplegics tobreathe without a respirator.

First hospital to use fetal heart monitoring.

Discovery of the sleep hormone melatonin.

First antiviral medicine 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 2014

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 medicine that is part of the three-medicine “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.

Genomic analysis leads to the discovery, diagnosis, and treatment of a rare disease.

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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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.

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 information from people who have a specific illness or condition, and to help establish

the safety, dosage, and side effects of a new medicine 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 (1-877-978-8343) for more information.

AT YALE, THERE ARE HUNDREDS OF CLINICAL STUDIES UNDER WAY FOR A WIDE VARIETY OF CONDITIONS.

Paul Taheri, MD, MBADeputy Dean for Clinical Affairs and CEO, 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.”

Yale-New Haven Hospital – OUR MISSION IS TO DELIVER THE HIGHEST-QUALITY CARE.

Our primary goal is to provide outstanding care and treatment to patients and their families. The

advanced treatments provided here were developed through medical research that takes place in our

hospital and the Yale School of Medicine. Thanks to the scientists, physicians, nurses, and other

staff members, and especially because of patients like you who participate in research studies, we are

privileged to offer safe cutting-edge treatments and procedures. With your help, we will continue our

efforts to find new and even more effective treatments and cures through research.

Marna BorgstromPresident and CEO, Yale-New Haven Hospital

“Yale-New Haven Hospital is committed to bringing the highest-quality care to patients by translating medical breakthroughs from the laboratory to the patient.”

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 otherwise unavailable.

• 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 specific 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 personal physician.

Yale Center for Clinical Investigation (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.

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.




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

WHAT HAPPENS DURING A CLINICAL TRIAL?

The clinical trial team includes a doctor, research nurses, and such other staff members 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 medicines, 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 medicines, 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?

You can help those whose work is helping millions.

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 medication used to treat cancer was tested in clinical trials.”

Peter G. Schulam, MD, PhD Director, Yale Cancer Center & Physician-in-Chief, Smilow Cancer Hospital (Interim)Professor of Urology and Surgery, Yale School of MedicineChair, Department of UrologyCo-Founder, Yale Center for Biomedical and Interventional Technology

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 findings 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 outcome in advance. Clinical trials are a treatment option for

many people with cancer. Depending 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 therapy 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 medicines. 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?

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 percent 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.

HOW SHOULD I PREPARE TO MEET THE RESEARCH COORDINATOR OR DOCTOR TO DISCUSS PARTICIPATING IN A CLINICAL TRIAL?

• 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.

• Record the discussion so you can listen to it again later.

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.

John Krystal, MDChair, Department of Psychiatry, Yale School of Medicine

“We see the crippling effects of mental illness and addiction every day. Research is the only way to develop innovative treatments for these diseases.”

Robert Malison, MDProfessor of Psychiatry and Director, Clinical Neuroscience Research Unit, Yale School of Medicine

Stephanie O’Malley, PhDProfessor of Psychiatry and Deputy Chair of Clinical Research, Department of Psychiatry, Yale School of Medicine

WHAT IF I HAVE A MENTAL ILLNESS OR SUFFER FROM ADDICTION?

Most of us know somebody who is affected by such disorders as

Alzheimer’s disease, depression, and tobacco or alcohol addiction.

These conditions can have devastating effects on patients and

their families. Sometimes people are hesitant to even discuss these

disorders or seek treatment for them. However, participating

in clinical research is the only way to discover the causes of and

potential new treatments for mental conditions. Without clinical

research, there is no hope of improving the lives of patients who

are suffering.

Yale conducts research on all types of psychiatric disorders and

substance abuse. In fact, we are at the forefront of research on these

conditions, and our researchers are working to translate the latest

scientific discoveries into treatments that can make a difference.

You don’t need to worry about privacy concerning your health

information. As with all research studies, doctors and staff who

conduct research on these types of disorders are extremely concerned

about protecting patient confidentiality and take this responsibility

very seriously. There are many checks and balances in place to ensure

that clinical studies protect the rights and privacy of participants.

For example, any information that identifies you is kept confidential.

In fact, disclosing such information is against the law. More than

that, your well-being is our number one priority, and that includes

protecting your privacy. Medical and research staff are happy to

discuss any concerns you may have about your participation in

clinical research and how the information gathered in the course of

this research is used.

WE PROTECT YOUR MEDICAL INFORMATION.

WHAT’S IMPORTANT TO YOU?

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

what language they speak, or where they live. 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 before joining a study.

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

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

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 when you meet with the study team to talk about the

study. The study team can help you understand the role of the research study and what it means for

you and your family.

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

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“ ”

If I participate in a research study, I won’t receive real medicine. Clinical studies 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 does not contain active ingredients. You will always be told when a placebo is used

in a study. Placebos are almost never used in studies for cancer therapies. For other diseases, standard

treatment plus a new treatment may be compared to standard treatment plus a placebo. Either way,

you are receiving 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 rules 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 during 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 specific

medical condition. These studies usually involve lifestyle interventions or behavioral changes.

Sometimes these programs have the potential to benefit you. Other studies merely collect information

by using a questionnaire. These kinds of studies are an opportunity to help your community at little

or no risk to you.

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 looking

tirelessly 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 use regularly 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.


“It’s hard to overestimate the value of genetic research. Understanding the genetic factors of diseases has already led to many exciting discoveries and is helping us move toward personalized medicine that will vastly improve care.”

Richard P. Lifton, MD, PhD Chair, Department of Genetics Sterling Professor of Genetics and Professor of Medicine

OTHER WAYS YOU CAN BE A PART OF MEDICAL RESEARCH.

As a patient at Yale, you can play an important role in improving health care. You can help doctors and

scientists learn about different diseases and how to treat them in several ways:

• By participating in a clinical trial that investigates a new medicine or procedure for your

particular illness.

• When information in your medical record is used to study diseases and the effects of treatments.

• When leftover blood and body tissue that have been used for your diagnosis and treatment are

saved and used for research.

Genetic information can be helpful in determining which people are at risk of certain disorders; to

individualize care; and to prevent diseases. Researchers may use some of your blood or tissue to map

a few genes or the complete set of human genes. They may also use certain cells from your tissue to

create a cell line for future research. In a cell line, identical cells are grown in small numbers in the

laboratory for use in research.

HOW DOES THIS TYPE OF RESEARCH AFFECT ME?

For research involving your medical records, leftover blood or tissue, or genetic testing, all of the

samples and information collected do not disturb or change your care in any way. There are no physical

or medical risks to you. You receive no direct benefit from this research, but your participation may

benefit patients like you and contribute to advances in medical care and treatment.

If you would like to find out more about the kinds of research conducted at Yale or how your

information or leftover samples are used for research, call 1-877-y-studies (1-877-978-8343).

If you are concerned about your safety in connection with a research study, call the Human Research

Protection Program at 203-785-4688.

If you have concerns regarding your privacy in connection with participating in research, call

1-877-y-studies (1-877-978-8343), option#3.

WHAT IF I HAVE ADDITIONAL QUESTIONS ABOUT PARTICIPATING IN RESEARCH STUDIES?

“Our job is to make sure our patients receive the best care possible. Clinical research makes that possible by helping us develop new treatments that can really make a difference.”

Thomas Balcezak, MD, MPHChief Medical Officer, Yale-New Haven Hospital

YOUR MEDICAL RECORDS CAN HELP RESEARCHERS.

Yale uses an electronic medical record system to access and store your medical information. This

digital version of your paper chart is a valuable resource because it brings all your medical information

together in one secure database. By allowing doctors and nurses to view your health records easily, the

electronic medical record results in improved diagnosis and treatment; fewer errors in patient records;

and faster, more efficient medical care.

The information contained in your electronic medical record is also a powerful tool for research. For

example, it helps doctors conduct studies on a large number of patients over long periods of time and

helps them identify patients who may be eligible for research studies. This translates into improved

medical treatments for everyone.

Whether providing top-quality medical care or conducting research to develop better treatments,

Yale is committed to protecting your privacy. We take every precaution to safeguard you and your

medical information.

HOW CAN MY LEFTOVER BLOOD OR TISSUE HELP RESEARCHERS?

When you have a medical test or procedure, your doctor takes only the amount needed for this

purpose, but there may be some tissue left over. By studying this remaining blood or tissue, researchers

can obtain valuable information. It can help them find out how different diseases start and progress

over time. It can also help researchers develop new tests or medicines, or learn more about diseases that

are passed on in families. If your tissue is used for research, your records and privacy are protected, and

only the information that is necessary for the research to be conducted is used.

WHAT IF I DECIDE I DON’T WANT MY MEDICAL RECORDS, BLOOD, OR TISSUE USED FOR RESEARCH?

When you undergo treatments or tests at Yale, your medical records, leftover blood and/or tissue

may be used for research purposes unless you opt out. You may opt out at any time by calling

1-877-y-studies (1-877-978-8343).

HOW IS MY PRIVACY PROTECTED?

• Protecting the confidentiality of medical records is required by law. We keep any information that

identifies you or your material confidential.

• Whenever possible, researchers connect information from your medical records to your tissue or

blood by using a code rather than your name.

• If researchers need to use some identifying information about you for their research, they

must undergo an approval process by a special committee that is responsible for protecting

research participants.

• We make sure that your genetic information from research is not available to any of your caregivers

and is not included in your medical record. This precaution helps to ensure that such outsiders as

insurance companies or employers do not discover anything about your genes.

• Researchers at Yale sometimes work with colleagues at other universities and research sites to

develop new treatments. However, your identity and information are never released to

researchers outside Yale. Your materials are provided to outside researchers either anonymously

or with a code that only Yale researchers know.

We protect your privacy in several ways:

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, in medical journals, and to various government agencies. Individual

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

HOW IS MY SAFETY PROTECTED?

Real People Who Are Helping Us Discover

“I wanted to help other women who had ovarian cancer.”

Jane Marin

Real People Who Are Helping Us DiscoverTHE BENEFITS OF EXERCISE FOR CANCER SURVIVORS.

During surgery for uterine cancer, doctors discovered that Jane Marin, then 50, also had ovarian cancer.

She hadn’t been exercising regularly before her diagnosis; and during chemotherapy, she felt too

nauseated to do much. When she received a call asking if she wanted to participate in an exercise study

for women with ovarian cancer, she jumped at the chance.

Many research studies have shown the benefit of physical activity for cancer survivors.

Melinda L. Irwin, PhD, MPH, Associate Director for Population Sciences, Yale Cancer Center, conducts

research on the role of lifestyle behaviors in cancer prevention and prognosis. Her research had already

shown the benefits of exercise in women with breast cancer. She wondered whether exercise might also

benefit women diagnosed with ovarian cancer.

Dr. Irwin conducted a home-based walking program to test the effect of exercise on quality of life

and blood biomarkers associated with prognoses in women who had completed treatment for ovarian

cancer. During the six-month program, Jane followed a walking regimen and participated in weekly

counseling sessions by phone with a certified cancer exercise trainer.

The results of the study show that exercise improves quality of life and cancer-related fatigue in women

diagnosed with ovarian cancer who had previously been sedentary. “To me, a major exciting finding

was that the women wanted to participate in the study and they really exercised a lot,” said Dr. Irwin,

noting that on average participants exercised 166 minutes per week.

Dr. Irwin would like to see lifestyle behavior programs implemented early as part of cancer treatment

plans. In order to do that, however, researchers have to test these programs in patients to find out

whether they are effective.

Exercising improved Jane’s mood, and helped her get physically fit and lose weight. Best of all, she is

cancer-free. But there is another reason she said she wanted to take part in the study: “I wanted to help

other women who had ovarian cancer.”

“We had no hesitation about putting him in this study. To know what Mitchell’s future might hold and how we might be able to stop some of the effects of this disorder is so valuable.”

Mitchell and his mom Amy


HELPING DOCTORS UNDERSTAND A RARE GENETIC DISEASE.

Amy’s newborn son was very sleepy and difficult to feed when she brought him home from the

hospital. At first, she wasn’t worried. She remembered that when her daughter had been a baby that

drowsiness is not unusual in an infant. In Mitchell’s case, however, a standard newborn screening test

revealed that he has a rare form of a group of diseases known as urea cycle disorders. Due to a missing

enzyme, he is unable to process protein normally, causing a dangerous buildup of ammonia that can

be toxic and ultimately fatal. When Amy asked her husband to take a photo of Mitchell asleep on her

shoulder the night before he was diagnosed, she had no idea her son was dying in her arms.

Today, Mitchell is a happy and energetic little boy who is thriving. His parents are able to keep him

healthy by controlling the amount of protein he takes in each day through a restricted diet and by

giving him medication to help get rid of any excess protein. But for them, that’s not enough.

When he was 10 months old, Mitchell’s parents enrolled him in a study to observe patients with urea

cycle disorders over several years. The study involves periodic blood work, which he needs in any case,

and provides information about Mitchell’s health and medical history. While his parents hope that

being in the study will help Mitchell, their main focus is that others will benefit from the information

he provides. “Although the study may not assist in finding a cure for Mitchell during his lifetime, it will

save other families from having to go through this in future generations,” said Amy.

Gathering information about diseases like the one Mitchell has helps doctors understand such disorders

so that they can find ways of preventing damage and develop better treatments. “It’s so critical to

helping children living with these disorders and future children. Collecting all this data could help

make their lives better,” said Amy.

Like many families whose children suffer from a devastating disease, Mitchell’s parents have many

questions about what’s in store for him. Their hope is that studies like the one he’s part of will provide

answers. “We had no hesitation about putting him in this study,” said Amy. “To know what Mitchell’s

future might hold and how we might be able to stop some of the effects of this disorder is so valuable.”


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

Curtis Patton


Dr. Thomas Gill with Curtis Patton.

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 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 disability prevention and health promotion.

The study aimed to change how older people live, teaching them lifestyle practices that can help them

maintain their independence.

Led by Thomas Gill, MD, the study was 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 study 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.



“He’s making history. For him and for our family, this was an unexpected opportunity of a lifetime.”

Joanne Conte, Jacob’s mom

HELPING TO STEADY THE BALANCING ACT OF DIABETES.

The five teenagers who went rock climbing at City Climb Gym in New Haven, Connecticut, were typical high

school students who lead active lives. What sets them apart is that they were taking part in a pioneering clinical

trial to test a system for treating their Type 1 diabetes, which can be complicated to manage.

The standard treatment for children and teenagers with Type 1 diabetes is either multiple daily insulin

injections or the use of an insulin pump. All of the teens in the study use the pump, first tested at Yale in

1979. While the pump has advanced diabetes treatment tremendously, it must be operated manually to

deliver the correct doses of insulin.

Yale doctors have worked with industry partners to develop what many refer to as an “artificial pancreas,”

an insulin pump that works with a continuous glucose sensor to adjust insulin delivery automatically

in response to the body’s demands. This closed-loop system would be a major advance for patients

with diabetes.

“The ability of the system to self-adjust automatically in the background while patients go about their daily

lives would really be transformative in the lives of people with diabetes,” said Stuart Weinzimer, MD, who

led the study.

During the clinical trial, the teens spent four days with a Yale medical team who monitored their blood

sugar levels while they took part in activities that included hiking, playing laser tag, and climbing a rock

wall. The Yale team also monitored the teens remotely even when they were asleep. Blood sugar levels can

fluctuate at night when patients aren’t monitoring themselves, causing some parents to stay up to check

repeatedly on their children.

Jacob Conte and Jacob Liedke, both 15, have mothers with Type 1 diabetes who have also participated in

clinical research. “There’s never been any question in my mind about having him participate in a study,” said

Nicole Liedke. “His diabetes control during this study was better than it’s ever been at home.”

For the boys and the other teens who participated in the study, it was an opportunity to learn more about

the disease and play a part in finding ways to manage their diabetes more easily.

“To me, this is the mechanical cure for diabetes that I’ve been waiting for my whole life,” said his mom.

“He’s making history. For him and for our family, this was an unexpected opportunity of a lifetime.”



“I feel like I am getting information and can prepare myself, or even prevent or slow down Alzheimer’s.”

Barbara Foster and Dorothy Hughes

PREVENTING ALZHEIMER’S DISEASE.

When Barbara Foster, 78, received a flyer about an Alzheimer’s disease prevention study, she was intrigued.

She remembered all too well caring for her mother, aunt, and uncle and the challenges they faced when they

had dementia. “I don’t want it to be like that for me and I want to know if it’s going to happen,” she said.

Dorothy Hughes, 82, heard about the same study through her older sister, who was undergoing eligibility

screening for the study and asked Dorothy to be her study partner. Her sister didn’t qualify for the study, but

Dorothy, who was experiencing minor memory issues, decided to find out whether she could participate.

Both women ultimately enrolled in the study. “This is the first effort in history to try to prevent Alzheimer’s

disease symptoms before they appear,” said Christopher van Dyck, MD, director of Yale’s Alzheimer’s Disease

Research Unit, who is heading the study at Yale; other study sites are located around the United States,

Canada, and Australia. Dr. van Dyck has conducted many studies involving patients with Alzheimer’s disease

and their relatives in order to better understand and treat the disease.

The study is a landmark clinical trial for people ages 65 to 85 with normal cognitive function, meaning the

ability to learn and remember. Participants undergo PET scans to determine whether they are at increased risk

of developing Alzheimer’s due to a buildup of beta amyloid protein, which forms plaques in the brain. Those

with elevated amyloid levels may be eligible to participate in the clinical trial to test whether an experimental

medication slows down cognitive decline. Another part of the study involves using PET scans to detect levels

of a protein called tau, which causes “tangles” in the brain that are associated with Alzheimer’s. Yale was one of

the first sites in the country to conduct PET imaging of tau deposits as part of this study.

Dorothy had never participated in a research study before, but she hopes that the results will help doctors learn

more about how Alzheimer’s affects the brain and how it progresses.

Barbara had participated in a research study in the past as a healthy volunteer, but had never taken part in a

study involving medication. She had many questions before deciding to take part in the study. “I feel like I am

getting information and can prepare myself, or even prevent or slow down Alzheimer’s,” she said. She believes

people should participate in clinical research not just to possibly help themselves, but for the potential benefits

to others.



“I had already been doing conservative treatment for 14 years so I already knew it wasn’t very effective. The research showed that the risks were low and the benefits were possible.”

Jennifer Guidry

Real People Who Are Helping Us DiscoverGETTING HER LIFE BACK.

Jennifer Guidry, 36, was at the end of her rope when she travelled to Yale from outside Boston to be

evaluated for a clinical trial. She had fallen and injured her back 14 years earlier. At first she had only

intermittent pain, but her condition deteriorated to the point where she needed a cane and a wheelchair to

get around. After trying a host of treatments, her doctor told her she would have to use narcotics and learn

to manage her pain. “My life was basically over,” she said.

Dissatisfied with her situation, she combed the medical literature in an attempt to find a way to treat her

condition, which was caused by an injury to her sacroiliac (SI) joint, which joins the lower back to the

pelvis. SI joint disorders can be easily misdiagnosed because the symptoms are similar to those of such

other conditions as a herniated disc or sciatica.

Jenn found a clinical trial being conducted at Yale to test how well a new FDA-approved surgical procedure

to treat SI joint disorders works compared to nonoperative care. “The fact that it was Yale made a

difference,” she said. “I felt like that gave it more legitimacy.” The minimally invasive procedure involved

placing three specially coated implants across the SI joint to eliminate motion. “The advantage of doing it

less invasively is that patients recover from surgery much more quickly because there’s not as much damage

to the surrounding muscle and soft tissues,” said Peter Whang, MD, FACS, who led the study.

When she arrived at Yale for the first study visit, Jenn couldn’t stand at the reception desk long enough to

sign in. When she woke up from surgery, her pain had been remarkably relieved. “That aching, grinding,

unstable feeling was gone,” she said. She went home the next morning and rapidly gained mobility. By two

weeks post-surgery, she was ready to give up her cane.

Today, Jenn is working and enjoying life. Her three children had always seen her as someone in pain who

couldn’t participate in their activities. Now they are amazed that she can keep up with them. Not long after

her surgery, she took her kids to the movies. It was raining, so she began to jog, something she hadn’t been

able to do for 14 years. “I was beaming and crying at the same time,” she said. “It’s those tiny little things

that hit home time and time again.”

“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 firsthand how those treatments benefit my patients.”

Robert S. Sherwin, MDAssociate Dean for Clinical and Translational SciencesDirector, Yale Center for Clinical InvestigationC. N. H. Long Professor of Medicine

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 2005 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 Yale pediatric endocrinologist William Tamborlane, MD.

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 (1-877-978-8343)

for more information.

HIC#1501015190

Documents

YCCI Brochure Generic