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 Medicine Ensign 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.
First U.S. hospital to allow healthy newborns to stay in rooms with their mothers.
Arthur Wright, a Yale physicist, produces the first X-ray image in the United States.
1896
1942
First antiviral drug developed. First hospital to use fetal heart monitoring.
1946
1947
1949
• Introduction of life-saving penicillin in the United States.
1957 1958
1959
1960
Discovery of the sleep hormone melatonin.
• The first use of chemotherapy to treat cancer in the United States. Yale-New Haven Hospital opens the first rheumatic fever-cardiac clinic, one of the nation’s earliest regional heart centers.
World’s first newborn intensive care unit.
• Develops 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.
• Discovery of the mechanism of protein folding—a step toward understanding such neurodegenerative conditions as Alzheimer’s disease.
The phrenic nerve pacemaker allows quadriplegics to breathe without a respirator.
• First documented heart transplants in adult identical twins—one in 1992, the second in 1997.
First insulin infusion pump for diabetes.
First U.S. hospital-based newborn screening program for sickle cell anemia.
1966 1972 1975
First fetal cardiovascular center in the United States.
1978
1979
1980
1985 1994
1997
The first genetically modified mouse; such mice are now used in the early stages of research to develop disease treatments.
Lyme disease identified and named. The FDA approves Zerit, an HIV drug that is part of the three-drug “cocktail” extending the lives of many thousands of people with HIV/AIDS worldwide. The FDA approves timolol to treat glaucoma; it is the first effective therapy for the disease since the early 1900s.
2010
First use of high-throughput DNA sequencing to diagnose disease.
“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.” David J. Leffell, MD Deputy Dean for Clinical Affairs for the Yale School of Medicine, CEO of Yale Medical Group
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 that from people who have a specific illness or condition, and to help establish the safety, dosage, and side effects of a new drug or treatment. All these research studies are an important and necessary step in the process of making sure new treatments are safe and effective. They also offer an opportunity for the volunteers who participate in them to try new or experimental treatment options; help bring new medicines to patients who need them; and make valuable contributions to the advancement of medical knowledge. If you’re interested in learning more, experts are available to help you find a clinical trial that’s best suited to you; explain what’s involved; and guide you through the process of enrolling and participating in a research study. Please visit our website, www.yalestudies.org, where you can review available trials and build your personal profile. Or call 1-877-y-studies (97883437) for more information.
Why do people participate in clinical trials? There are many reasons why people volunteer to take part in a clinical trial: • Some volunteers have a condition that is being treated effectively but they want to help doctors find out more about it in order to develop new treatments. • Sometimes volunteers have a friend or loved one with an illness or injury and they want to participate in a research study as a way to help that person and others who may suffer from the same condition. • It may be that there is no effective treatment for an illness or injury, or that the existing treatment has harsh side effects. Participating in a clinical trial may offer potential experimental options that might be unavailable otherwise. • Many people choose to participate in a study even though it might not help them directly. Knowing that others may benefit from their efforts is a rewarding experience. • Sometimes people volunteer because they are compensated financially for their time and effort.
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 certain disease, and your previous treatment or medical history. Some of the ways to determine whether a clinical trial is right for you include: • Comparing the reason why you’re interested in participating to the question the trial hopes to answer. You should think about whether the trial has the potential to fulfill your hopes and expectations. You should also weigh the potential risks and benefits of participating in the trial. • Informing yourself about the questions the trial is trying to answer by doing your own research on reputable websites and in the library, and by asking questions. You may also want to talk to your family, friends, or your personal physician. YCCI staff members, study doctors, nurses, and coordinators are available to answer your questions so
that you can make an informed decision.
It’s surprising how many have helped make
ordinary people 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 (97883437) for more information.
Help us discover Be part of Clinical Research at Yale
You can help those whose WHAT HAPPENS DURING a clinical trial? The clinical trial team includes a doctor, research nurses, and such other staff as study coordinators and technicians. They will guide you through the process of enrolling and participating in the study and will also be able to answer your questions about the trial. Trials may involve: • Testing new drugs, devices, or treatments • Questions about your health history • Analyzing such biological specimens as blood • Using such diagnostic techniques as imaging scans to learn about a condition or treatment Some trials require an overnight stay in the hospital, but many involve only clinic or office visits. The clinical trial team will explain exactly what’s involved before you enroll in a study.
work is helping millions. What should I consider before agreeing to participate in a trial? You should know as much as possible about the trial and feel comfortable asking the research team any questions about what’s involved. The following questions may be helpful: • What is the purpose of the trial and how long will it last? • What drugs, devices, procedures, tests, examinations, or visits are required in order to participate? • Will I have to change my daily activities or diet if I participate? • What are the standard treatment options for my condition if I choose not to participate? • Whom should I contact if I have questions about the trial?
It gave me more options and a better outlook possibly on the future. Kathy - Cancer trial volunteer
“We’ve made tremendous strides in treating cancer. Patients are living longer and enjoying a higher quality of life. That’s been possible because every single drug used to treat cancer was tested in clinical trials.” Thomas J. Lynch, MD Director, Yale Cancer Center Physician-in-Chief, Smilow Cancer Hospital at Yale-New Haven Hospital
Do I need to have an illness to participate in a clinical trial? No, you don’t have to have a specific illness or condition to participate in a clinical trial. In fact, there are many trials that need healthy volunteers. Participants who are healthy are often needed to provide information that can be compared with that from people who have a particular disease.
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 in advance. Clinical trials are a treatment option for many people with cancer. Based on the questions the research is trying to answer, each clinical trial has guidelines on who may or may not join the trial. These guidelines help ensure your safety and the accuracy of the study’s results. If you have cancer or another illness, you should discuss with your doctor whether participation in a clinical trial is right for you.
Will I receive a placebo? A placebo is a substance designed to look like the medicine being tested, but it is not active. Placebos are almost never used in cancer treatment trials. In some cases, a study may compare standard treatment plus a new treatment, to standard treatment plus a placebo. You will be told if the study uses a placebo.
“I work in clinical research but I’m also a parent. I want to know that the medicines I give my son are safe and effective. The best way to find that out is through clinical research.” Tesheia Johnson, MBA, MHS Associate Director for Clinical Research, Yale School of Medicine Chief Operations Officer, Yale Center for Clinical Investigation
What about children’s participation in clinical trials? Children are not small adults. It’s important to include them in clinical trials to make sure medications are safe for young patients and to determine the proper dosage of these drugs. Researchers are careful to design child-friendly studies of short duration that make it as easy and comfortable as possible for young patients and their families to participate.
why do research in children? Parents want to know that the medicines they give their children are safe and effective. Medicines, devices, and treatments, however, are often not tested in children. Children are given a medication in nearly half of medical visits — but 70% of those medicines have been tested only in adults. If children don’t participate in clinical research, we have no way of knowing how their bodies handle medicines and other treatments over time.
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. • Bring a tape recorder and record the discussion so you can listen to it again later.
Hundreds of future life-saving 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 for a study. • Some people may not know what a clinical study is.
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.
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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
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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. 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 certain 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.
Medical research changes
lives. You can change the course of medical research. Scientists and doctors at Yale are working hard to bring you new medical treatments. They are tirelessly looking for novel therapies to treat disease. But they can’t do it without your help. They need volunteers for clinical research to help bring discoveries from the laboratory to people who need them. The medicines that you and your family regularly use are at your disposal thanks to those who have participated in clinical research. We hope you’ll be one of them. Hundreds of potentially life-saving treatments may never get to people who need them without your help. Help make a difference by volunteering for a clinical trial. Please visit our website, www.yalestudies.org, where you can review available trials and build your personal profile. Or call 1-877-y-studies (97883437) for more information.
Help us discover Be part of Clinical Research at Yale
“My job is to protect you and to make sure that clinical trials at Yale are as safe as possible for those who participate.� Sandra Alfano, PharmD, FASHP, CIP Acting Director, Human Research Protection Program
(Above) Dr. Robert Sherwin with a patient in a diabetes study.
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, to medical journals, and to various government agencies. Individual participants’ names remain secret and are not mentioned in these reports.
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.
Real People Who Are
“Clinical studies can be an opportunity to find out and learn about yourself.� Curtis Patton Lifestyle Interventions and Independence for Elders (LIFE) Study
Helping Us Discover
(Above) Curtis Patton with Dr. Thomas Gill, leader of the LIFE study.
Maintaining Older Adults’ Independence At 76, Curtis Patton had the usual ailments of a person his age. So when he received a letter in the mail encouraging him to participate in a clinical trial for older adults, he was intrigued. The study, Lifestyle Interventions and Independence for Elders (LIFE), was designed to prevent or delay mobility disability – the inability to walk a quarter of a mile – in adults aged 70 to 89. Participants were randomly assigned to either a physical activity program or a series of workshops focused on strategies related to prevention and health promotion. The study aims to change how older people live, teaching them lifestyle practices that can help them maintain their independence. Led by Thomas Gill, MD, the study is being conducted through Yale’s Program on Aging. This program offers several clinical trials that evaluate the factors that play a role in aging and test interventions to increase older adults’ independence and quality of life. Like most of the other LIFE participants, Patton believes the study has been beneficial to him, giving him the tools to negotiate his life as he gets older. He also recognizes that clinical research has the potential to benefit many others, including his family, the community, and the nation.
Real People Who Are The Rosenfield family
“Clinical research is really important and it’s the only way things are going to change. Look at the diseases research has eradicated. Maybe diabetes could be the next one – but it will never happen if there’s no research.” Amy Rosenfield Daughter Hannah ( far left) participated in a diabetes trial
Helping Us Discover
(Above) Rachel Rosenfield has blood drawn as part of a clinical trial to prevent and treat type 1 diabetes.
Treating and Preventing Diabetes When Hannah Rosenfield was diagnosed with type 1 diabetes at age 10, her mother Amy immediately looked beyond the standard treatment for something that might benefit her daughter long term. Amy’s search led her to a clinical trial at Yale for those newly diagnosed with type 1 diabetes, sometimes called juvenile-onset diabetes. Within weeks of her diagnosis, Hannah was enrolled in the two-year study. Hannah responded well to the experimental treatment. Almost four years after her diagnosis, she was still producing small amounts of insulin. Hannah also participated in a follow-up study to find out the longer-term effects of the new drug she had taken. Hannah’s three siblings have participated in a clinical trial for relatives of type 1 diabetes patients—part of a series to prevent and treat the disease in its early stages. Knowing whether their other children are at risk for developing diabetes has given Hannah’s parents peace of mind. For the Rosenfields, participating in clinical trials has offered both hope and encouragement. They know they’ve done everything possible not just for Hannah and her siblings but also for countless others who suffer from diabetes.
“As a researcher, I’m proud to lead Yale’s clinical research program and play a role in developing new treatments. As a doctor, I see firsthand how those treatments benefit my patients.” Robert Sherwin, MD C.N.H. Long Professor of Medicine Director, Yale Center for Clinical Investigation
Yale is committed to improving the health of patients in New Haven and around the world. The Yale Center for Clinical Investigation (YCCI) was launched in 2006 to promote clinical and translational research and to train the next generation of investigators to develop therapies that will make our lives better. YCCI was one of the first 12 centers to be funded by the National Institutes of Health as part of an initiative to bring medical research from the laboratory to patients. YCCI is headed by Robert Sherwin, MD, a world-renowned physician scientist who is a leader in diabetes research. In 1979, he developed the insulin pump with William Tamborlane, MD, who is now YCCI’s deputy director for clinical research. Today, the insulin pump is used by hundreds of thousands of diabetes patients.
Innovative research that leads to the discoveries of treatments like these is the reason YCCI was established. By providing scientists and doctors with the tools they need to conduct pioneering research, YCCI aims to bring medical advances to patients who need them. You can help us by volunteering for clinical research.
To find out more about clinical trials at Yale, visit our website, www.yalestudies.org. Or call 1-877-y-studies (97883437) for more information.