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Yale Center for Clinical Investigation

Yale Center for Clinical Investigation (YCCI)

Select one of the categories below to view a list of relevant trials.

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Studies for Healthy Volunteers

You don't have to be sick to participate in clinical research. There are many studies that need healthy volunteers. Participants who are healthy are often needed to provide information that can be compared with people who have a specific illness or condition. Healthy volunteers are also needed in early clinical research studies to help establish the safety, dosage, and side effects of a new drug or treatment. Your participation as a healthy volunteer is an important part of helping researchers develop new treatments and bringing them to patients around the world.

If you're healthy and decide to participate in clinical research studies, you may receive a physical exam, undergo certain tests (for example blood tests or imaging scans) or answer questions about your health and lifestyle. Clinical trial staff will explain exactly what's involved and will answer any questions you might have.

[LINK OR DISPLAY STUDIES FOR HEALTHY VOLUNTEERS]

Aging

The fastest and safest way to determine whether new treatments work is through clinical research. Older people are underrepresented in clinical research because most treatments used to treat older patients are studied in younger people. Doctors have to draw conclusions from these studies when treating older patients, many of whom may have multiple conditions. Some conditions may also affect older people differently. It’s important for scientists to be able to study these conditions in older people in order to develop effective treatments.

Many clinical studies involving those over 60 do not involve drugs. Instead, they may test the effect of behavioral and lifestyle changes. Yale has a long track record of providing clinical care for older people and has been conducting research involving older people for almost 40 years. Yale is also partnered with the VA and several studies are conducted at or with the VA hospital in West Haven.

[LINK OR DISPLAY STUDIES FOR AGING]

Common Concerns

If I volunteer for a study, will I definitely be able to participate?

Every trial has eligibility criteria that are used to make sure participants are suited to the study. A basic list of eligibility criteria is provided, but there may be other factors to consider. The study team may ask you additional questions to make sure the study is right for you. Even if it’s not, you may be eligible for other studies.

I am basically healthy, but I have a minor health condition that is under control. Does this mean I can’t be a healthy volunteer?

It’s common for older people to have some health issues, but that doesn’t necessarily mean you can’t be a healthy volunteer, depending on the study. For example, if you have high blood pressure that is kept under control with medication, you may be eligible to participate in studies that need healthy volunteers.

I would like to participate in clinical research but transportation is an issue for me.

We go out of our way to make it as convenient as possible to participate in clinical research. Garages are available and sometimes valet parking is an option. Some studies will be able to provide transportation to and from the study site.

Even though I’m retired, it would be difficult to participate because I take care of my grandchildren.

The study team is often able accommodate your needs and schedule. Questions related to the study can often be handled over the phone and Saturday appointments are often available.

I’m worried about safety. What happens if I become ill due to side effects from medication given during a clinical trial?

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. All trials also follow a carefully monitored study plan that details what researchers will do during the study.

Before beginning the study, you will undergo a thorough screening to make sure you are healthy enough to participate safely. The study team will provide you with instructions to follow if you suffer from side effects, including how to contact them at any time. They will encourage you to call if you have any questions or concerns regarding treatment administered as part of the study.


I’m concerned about privacy and confidentiality.

The ethical and legal codes that govern medical practice also apply to clinical trials. The same measures that are in place to protect your privacy and confidentiality when you visit your doctor apply to clinical research. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participant’s names remain secret and are not mentioned in these reports.

If I participate in a clinical trial, can I still go to my regular doctor?

The medical care you receive as part of a research study is in addition to the medical care provided by the physicians you normally see. You are not replacing your doctor by participating in a research study.

I’m too sick to be in a clinical trial.

Whether you’re sick or well, we’re interested in your experiences.

I’m too healthy to be in a clinical trial.

Whether you’re sick or well, we’re interested in your experiences. Even if you’re not sick, you may be able to participate in research aimed at improving the quality of life for older people.

Resources

Yale Program on Aging

National Institute on Aging

Alliance for Aging Research

Centers for Disease Control and Prevention Healthy Aging

US Department of Health and Human Services Aging

Children's Health

Yale’s outstanding doctors and scientists actively study diseases to develop new treatments for improving children’s health. Children are not small adults and medicines may act differently in their bodies. It’s important to test new treatments in children of all ages. Clinical research is the fastest and safest way to explore new therapies and find out if they work.

Innovative Research at Yale

Yale has a long track record of innovative research leading to better medical care for children. Research studies at Yale have led to major advances and better understanding of diseases, such as:

  • The insulin pump to treat diabetes
  • The world’s first intensive care unit for newborns
  • The first hospital to use fetal heart monitoring
  • The first hospital-based newborn screening program for sickle cell anemia
  • Identifying Lyme disease and showing that antibiotics can effectively treat it
  • Eliminating HIV in newborns in New Haven by screening pregnant women and newborns
  • Treating HIV-positive pregnant women to prevent transmission to their newborns
  • Identifying genetic mutations associated with dyslexia
  • Testing an artificial pancreas in children with Type 1 diabetes

[LINK OR DISPLAY STUDIES FOR Children]

Why Children Should Participate in Research

Parents want the most advanced therapy for their children. New therapies are available to children once they have been tested in research studies. Yale conducts clinical research of the highest quality in order to offer the best treatments available for children.

It’s normal for parents to have concerns about research in children. Here are some points you should consider:

Yale follows strict rules and regulations regarding the safety of its clinical trials.

The ethical codes and laws that govern medical practice also apply to clinical trials. At Yale, every clinical trial involving children is approved and monitored by a committee comprised of pediatricians and other experts to make sure it is safe. Clinical trials are also approved and monitored by an independent committee of doctors, community advocates, and others, who make certain the rights of study participants are protected. This committee makes sure that the risks are as low as possible and that the potential benefits are worthwhile.

There are special protections for research involving children.

These special protections for children are part of the codes and laws that govern clinical trials. At Yale, doctors, nurses, and other experts also carefully review each study in detail before a single child is enrolled.

Your child should have a say in whether or not to participate in a research study.

As a parent, you have to give legal consent for your child to enroll in a research study. But you also need to think about how your child feels about being in a study. There is a process called “assent,” which means that children are given basic facts about a study and asked to be part of the decision. All kids are different. Some may want to be part of the process, while others may not. Some children may be uncertain, fearful, or too young to understand what is being asked of them. At any age, your child’s input should be valid and he or she should feel comfortable.

It’s up to you.

As a parent you must be comfortable with what your child will be doing in a study. Make sure you understand the possible risks and benefits and how they apply to your child. Get to know the study team, whose job it is to protect your child. Make sure you understand your rights when your child participates in a study. Don’t be afraid to ask questions.

Courtesy of the National Heart Lung and Blood Institute

The Importance of Participation

The vaccinations, medicines, and other medical advances that help keep your child healthy are available thanks to families who are willing to participate in clinical research.

A study conducted in 2013 found that 44 % of parents would consider allowing their children to participate in clinical research if their children had the disease being studied. Yet only about 5 percent of families have a child who has taken part in a research study.

Whether it’s a study to test a new vaccine or medicine or answer questions about mental health or nutrition, it’s important for children to participate to help make sure new treatments are safe and effective.

Source: C.S. Mott Children’s Hospital National Poll on Children’s Health, 2013

Resources

Yale Medicine Pediatrics
https://dev.yalemedicine.org/departments/pediatrics

Yale Child Study Center
https://medicine.yale.edu/childstudy/

National Institute of Child Health and Human Development

Should Your Child Be in a Clinical Trial, US Food and Drug Administration

Type 1 and Type 2 Diabetes, Obesity, and Weight Management

For decades, Yale University has been committed to better understanding the causes and treatment of diabetes. From the first successful studies of insulin pump technology in the 1970s, to current investigations directed at understanding the cellular mechanisms underlying Type 2 diabetes and the immunologic basis of Type 1 diabetes,

Yale is at the forefront of diabetes research. Clinician-scientists at Yale University School of Medicine have received numerous grants from the National Institutes of Health (NIH), the American Diabetes Association and the Juvenile Diabetes Research Foundation (JDRF) to support ongoing innovative and cutting-edge research in diabetes and metabolic disorders.


Like many discoveries, the development of the first insulin pump was a combination of ingenuity and teamwork. In 1979, Dr. Robert Sherwin and Dr. William Tamborlane developed the insulin pump to treat Type 1 diabetes. Today, it’s used by more than 350,000 diabetic patients and its popularity continues to grow. Without volunteers like the children and their families who were willing to participate in clinical research, this groundbreaking discovery would not have been possible.

Yale’s tradition of discovery continues through research to improve our understanding of diabetes and obesity, including prevention, causes and better treatments – but we can’t do any of this without you! By participating in a research study, you are not only able to help others in the future, but you may gain access to new treatments before they are widely available and could be the first to benefit from such treatments. You are also able to obtain care from specialists at a leading healthcare facility while participating in a study.

Click here to complete a questionnaire which will help us match you to studies for which you may be eligible.


Please call (203) 737-4777 or email diabetes.research@yale.edu for more information.

[LINK OR DISPLAY STUDIES FOR Diabetes]

Underserved Minority Populations

Human beings are very much alike. Only one-tenth of one percent of our genes varies from one person to the next. But even though we are very similar, illnesses – and the medications that treat them – affect each of us differently, depending on our gender, age, health, ethnicity and race.

It’s important to test new treatments in different groups of people in order to understand what treatments work best for them. The best way to know that a particular medicine is right for someone is to test it in similar people.

African American

It is an unfortunate fact that many diseases affect African Americans more than other groups. For example:

  • African Americans are more likely to have stomach cancer than other groups. Men have higher rates of lung and prostate cancer. Breast cancer is more common in African American women under 45 and they are more likely to die from this disease than other women.
  • African Americans are twice as likely as non-Hispanic white adults to be diagnosed with diabetes. They are also more likely to have kidney disease; be hospitalized; and to die from diabetes.
  • African Americans have higher rates of high blood pressure. Men are more likely to die from heart disease. Women are more likely to be obese.
  • African American infants are almost four times as likely to die from causes related to low birth weight compared to non-Hispanic white infants.
  • African Americans are more likely than white adults to have a stroke. Men are 60% more likely to die from it. Survivors are more likely to become disabled and have difficulty with daily activities.

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 in the general population.

Cultural Ambassadors

Although African Americans suffer disproportionately from such diseases as diabetes, high blood pressure and certain cancers, they are underrepresented in clinical trials. The Yale Center for Clinical Investigation (YCCI) is collaborating with the African Methodist Episcopal (AME) Zion Church to help increase the participation of the local African American community in clinical trials. The partnership helps ensure that clinical studies are designed to combat diseases that affect New Haven’s African American community.

Representatives of AME Zion Church, one of the nation’s oldest African American denominations, are serving as cultural ambassadors to Yale’s research programs, advising investigators how best to raise awareness of clinical research. YCCI provides cultural ambassadors with intensive training on clinical research topics so that they are able to answer your questions about participating in research. It is our hope that this collaboration will increase the participation of African Americans. Our goal is to bring medical advances to patients who need them.

[LINK OVER TO CULTURAL AMBASSADORS]



Hispanic

It is an unfortunate fact that many diseases affect Hispanics more than other groups. For example:

  • Hispanic men and women are twice as likely to have, and to die from, liver cancer. Hispanic women are more likely to have stomach cancer and cervical cancer than other women.
  • Hispanic children are more likely to have asthma than other children.
  • Hispanic women are more likely to be diagnosed with HIV infection than non-Hispanic white women.
  • Hispanic men and women are more likely to have AIDS and are more likely to die from HIV/AIDS.
  • Hispanic women are more likely to have a stroke than other women.
  • Hispanics are twice as likely to die from viral hepatitis. They are twice as likely to be diagnosed with Hepatitis A and adults 40 years and over are 30% more likely to develop Hepatitis B.

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 in the general population.

Cultural Ambassadors

Although Hispanics suffer disproportionately from such diseases as diabetes, asthma, and certain cancers, they are underrepresented in clinical trials. The Yale Center for Clinical Investigation (YCCI) is collaborating with JUNTA for Progressive Action to help increase the participation of the local Hispanic community in clinical trials. The partnership helps ensure that clinical studies are designed to combat diseases that affect New Haven’s Hispanic community.

Representatives of JUNTA, New Haven’s oldest Latino community based non-profit organization, are serving as cultural ambassadors to Yale’s research programs, advising investigators how best to raise awareness of clinical research. YCCI provides cultural ambassadors with intensive training on clinical research topics so that they are able to answer your questions about participating in research. It is our hope that this collaboration will increase the participation of members of the Hispanic community in clinical research. Our goal is to bring medical advances to patients who need them.

[LINK OVER TO CULTURAL AMBASSADORS and bios]



Common Concerns

If I participate in a research study, I won’t get real medicine.
Clinical studies will often compare one treatment that is known to be effective with another treatment that may be more effective. Some studies involve a placebo – sometimes called a “sugar pill” – that is not active. You will always be told if a placebo is used in a study. Placebos are almost never used in studies for cancer. For other diseases, standard treatment plus a new treatment may be compared to standard treatment plus a placebo. Either way, you are getting real medicine.

The researchers can do whatever they want. I’m just a guinea pig.
Like all health care providers, the study team conducting research must follow rules and laws that protect your safety. Many of these are mandated by the federal government. Every clinical trial in the United States is approved and monitored by a committee whose job is to ensure your safety. At Yale, these committees are part of the Human Research Protection Program, which ensures that Yale studies are conducted ethically. All trials also follow a study plan that states exactly what researchers will do in the study.

I don’t trust doctors and it’s often difficult to communicate with them because of the language barrier.
All health care providers, including members of the study team, are concerned about your health. Any questions they ask you are directly related to your well being. Yale has translators available and JUNTA representatives are working with Yale researchers to provide translation services for the Hispanic community.

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.

Women's Health

The fastest and safest way to determine whether new treatments work is through clinical research. Traditionally, fewer women than men have participated in clinical research. However, some treatments may work differently in women than men. It’s important for women to participate in clinical research order to help scientists understand gender differences in health and disease.

For example, women who smoke have a higher risk of lung cancer and cardiovascular disease than men. While men are more likely to smoke due to the effects of nicotine, women are more likely to smoke in order to relieve stress and regulate their moods. Yale has created a research center to address these issues by developing gender-sensitive treatments that aid women in quitting smoking.


There are many research studies underway at Yale that need female volunteers. Some are designed to test treatments for diseases that primarily affect women, while others seek to understand gender differences that may lead to more effective treatments for women.

Common Concerns

How will I know if the study is safe for me since I’m of childbearing age and I could be pregnant?

Like all health care providers, the study team conducting research must follow rules and laws that protect your safety. Many of these are mandated by the federal government. Every clinical trial in the United States is approved and monitored by a committee whose job is to ensure your safety. At Yale, these committees are part of the Human Research Protection Program, which ensures that Yale studies are conducted ethically. All trials also follow a study plan that states exactly what researchers will do in the study. In studies that involve drugs or interventions that should not be given during pregnancy, researchers will ask is if you are or might be pregnant before the study begins.

Between my job and taking care of my family, how will I find the time to participate in a study?

Research teams go out of their way to ensure that participating in a study poses as little inconvenience to you as possible. Appointments are scheduled based on your availability, parking is often provided, and some studies offer financial compensation. If you decide to participate in a study, the study coordinator will work with you to accommodate your needs.

It seems I rarely hear about research findings and how they apply to me.

It takes a long time – 12 years on average for new drugs – to bring discoveries from the laboratory to patients. To develop a new medicine, for example, scientists first conduct basic research in the laboratory to understand a disease, look for possible targets for treatment, identify a drug that may act on the target and find out if the drug is suitable for testing in people. After this process, the drug is tested in clinical trials in people. Clinical trials occur in phases. A potential medicine must successfully complete all of the phases before being submitted to the Food and Drug Administration for approval.

Yale University communicates its research findings online, on social media platforms, and in publications. One source of information is Women’s Health Research at Yale, where you can learn about discoveries and improvements in health and health care.

Resources

Women’s Health Research at Yale

National Institutes of Health Information on Women’s Health
Centers for Disease Control and Prevention Women’s Health

National Institutes of Health Office of Research on Women’s Health

US Department of Health and Human Services womenshealth.gov

Highlighted Studies

Yale has hundreds of clinical studies underway for a wide variety of conditions. None of them would be possible without volunteers who were willing to take part in clinical studies. Volunteers like you are the only way for medical breakthroughs to reach the public. Please consider participating in a clinical study and helping Yale continue its tradition of advancing medical knowledge.

[CAN WE STILL HAVE. A LIST OF HIGHLIGHTED STUDIES SOMEWHERE?]