Help us discover - African American brochure

Help us discover Be part of Clinical Research at Yale

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.

“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.”

Nancy J. Brown, MD Dean, Yale School of Medicine, C.N.H. Long Professor of Internal Medicine

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.

First U.S. hospital to allow healthy newborns to stay in rooms with their mothers.

The phrenic nerve pacemaker allows quadriplegics to breathe without a respirator.

Yale School of Medicine and YCCI partnered with the AME Zion Church and Junta to develop the Cultural Ambassadors program.

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 hospital to use fetal heart monitoring.

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

Discovery of the sleep hormone melatonin.

PD-L1 immunotherapy breakthrough.

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

• First documented heart transplants in adult identical twins – one in 1992, the second in 1997.

Yale New Haven Hospital opens the first rheumatic fever-cardiac clinic, one of the nation’s earliest regional heart centers.

Yale conducts and designs clinical research trials to fight COVID 19.

The FDA expedited approval of esketamine, derived from ketamine, and administered as a nasal spray, citing its major benefits for those with treatment-resistant depression.

First fetal cardiovascular center in the United States.

Lyme disease identified and named.

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1979

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

• Introduction of life-saving penicillin in the United States.

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

First antiviral medicine developed.

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1997

The FDA approves Zerit, an HIV medicine that is part of the threemedicine “cocktail” extending the lives of many thousands of people with HIV/AIDS worldwide.

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2018

First use of high-throughput DNA sequencing to diagnose disease.

Yale received one of the original twelve Clinical and Translational Sciences Awards (CTSA) funded by the National Institutes of Health (NIH).

The Yale CTSA was renewed in 2011 and 2016.

Yale School of Medicine and YCCI partnered with the FDA Office of Minority Health and Health Equity to increase diversity in clinical trials.

• 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 FDA approves Timolol to treat glaucoma; it is the first effective therapy for the disease since the early 1900s.

World’s first newborn intensive care unit.

The first genetically modified mouse; such mice are now used in the early stages of research to develop disease treatments.

2019

Yale Center for Clinical Investigation (YCCI) was created to support and facilitate clinical and translational research and training.

Yale leads in the approval of pediatric artificial pancreas.

2020/2021

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 UNDER WAY 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 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.

“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.”

Paul Taheri, MD, MBA Deputy Dean for Clinical Affairs and CEO, Yale Medicine

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.

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

Marna Borgstrom, MPH CEO, Yale New Haven Health System

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.

HOW DO I KNOW A CLINICAL TRIAL IS RIGHT FOR ME? 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.

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.

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.

Help us discover Be part of Clinical Research at Yale

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 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.

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?

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It gave me more options and a better outlook possibly on the future.

Kathy - Cancer trial volunteer

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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.

WHAT IF I HAVE AN ILLNESS LIKE CANCER? SHOULD I PARTICIPATE IN A CLINICAL TRIAL? 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? 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.

“Today, Yale Cancer Center is leading cutting-edge clinical trials that are advancing the next generation of cancer therapies.

This great progress would not be possible without the many volunteers actively participating in clinical trials that will ultimately improve the lives of cancer patients across the globe.”

Nita Ahuja MD, MBA, FACS William H. Carmalt Professor of Surgery; Chair, Department of Surgery; Interim Director, Yale Cancer Center; Interim Physician-in-Chief, Smilow Cancer Hospital

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.

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.

“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.”

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.

Tesheia Johnson, MBA, MHS

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

Associate Director for Clinical Research, Yale School of Medicine Chief Operations Officer, Yale Center for Clinical Investigation

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

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.

WE PROTECT YOUR MEDICAL INFORMATION. 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.

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

Stephanie O’Malley, PhD Elizabeth Mears and House Jameson Professor of Psychiatry; Director, Division of Substance Abuse Research in Psychiatry; Deputy Chair, Clinical Research

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 which 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.

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.

NOT ALL DISEASES ARE CREATED EQUAL. 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 than other women to die from this disease.

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

Courtesy of US Department of Health and Human Services Office of Minority Health.

WE WANT TO MAKE A DIFFERENCE. Yale is committed to developing treatments to lower the toll of chronic disease.

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

Rev. Dr. Leroy O. Perry, Jr.

Rev. Elvin Clayton

Pastor, St. Stephens AME Zion Church, Branford, CT and Cultural Ambassador to the Yale Clinical Research Program

Pastor, Walter’s Memorial AME Zion Church, Bridgeport, CT and Cultural Ambassador to the Yale Clinical Research Program

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.

Rev. Eldren Morrison Former pastor of Varick Memorial AME Zion Church, New Haven, CT. Now Pastor of Shaw Temple AME Zion Church, Smyrna, GA

Dr. William Tamborlane examining a young participant.

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

WHAT’S IMPORTANT TO YOU?

WHAT YOU SHOULD DO.

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.

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.

• 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.

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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

ADDRESSING COMMON BELIEFS. 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.

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 your health and the health of your family.

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.

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.

Help us discover Be part of Clinical Research at Yale

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 effect 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 amounts 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.

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

“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.”

Murat Gunel, MD, FACS, FAHA, FAANS Nixdorff-German Professor of Neurosurgery and Professor of Genetics and of Neuroscience; Chair, Department of Neurosurgery; Chief, Neurosurgery, Yale New Haven Health System; Chair, Perioperative Executive Leadership Committee; Director, Residency Program; Member, National Academy of Medicine; Co-Director, Yale Program on Neurogenetics Photo courtesy of Peter Baker Studios

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.

“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, MPH Senior Vice President and Chief Medical Officer, Yale New Haven Health System

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? We protect your privacy in several ways: • 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.

HOW IS MY SAFETY PROTECTED? 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.

Real People Who Are Helping Us Discover THE 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.

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

Jane Marin

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.”

Real People Who Are Helping Us Discover “PAVING THE WAY” THROUGH A RARE GENETIC DISEASE – MITCHELL THEN AND NOW Mitchell enjoys recess and math, and at ten years old, has an ordinary on-again off-again relationship with his older sister. In appearance and activity, he’s a typical child – the very picture of health. That picture is a radical reversal from his early months, when it was far from certain he’d survive to his first birthday. “They basically handed him back to me at 14 days old and said that he might not survive the first year, and probably would not see five years,” said Mitchell’s mother, Amy. While today Mitchell appears healthy, the first three years of his life were riddled with uncertainty and fear as he battled an inherited enzyme deficiency, Urea Cycle Disorders (UCD). UCD is a rare, medically mysterious, and largely unknown condition. Its symptoms are widely variable from person to person, and the long-term effects of having it – even barring frequent ammonia attacks – are uncertain. His current stable state is dependent on an exactingly regimented diet of formula and medications delivered to him four times a day through a tube into his stomach.

When Mitchell was 10 months old, Amy enrolled him in a longitudinal study to learn more about UCD through observation. While there is still no cure for his condition, researchers are continually learning more to develop different treatments and medications to manage it. Thanks to his formula and medications, Mitchell has been largely stable since the initial years following his diagnosis.

“That’s why I like to be able to participate in these studies, to be able to pave the way and hope to be able to provide information that will assist other families in making their lives easier.”

Amy, Mitchell’s mom

Real People Who Are Helping Us Discover

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.

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

Curtis Patton

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.

Real People Who Are Helping Us Discover 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.”

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

Joanne Conte, Jacob’s mom

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.”

Real People Who Are Helping Us Discover 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.

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

Barbara Foster and Dorothy Hughes

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.

Real People Who Are Helping Us Discover GETTING 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.

“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

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.”

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 Brian R. Smith, MD and John Krystal, MD, world-renowned physician-scientists. Innovative research that leads to the discoveries of treatments such as the insulin pump to treat diabetes, two drugs to treat HIV infection and the first treatment that arms the body’s cells to create a cancer-fighting immune response, are 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.

“As researchers, we are proud to lead Yale’s clinical research program and play a role in developing new treatments. As physicians, we see firsthand how those treatments benefit patients.”

Brian R. Smith, MD

John Krystal, MD

Co-director, Yale Center for Clinical Investigation; Deputy Dean for Scientific Affairs (Clinical Departments); Chair, Department of Laboratory Medicine

Co-director, Yale Center for Clinical Investigation; Chair, Department of Psychiatry; Chief of Psychiatry, Yale New Haven Hospital

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.

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