Clinical Research at Christiana Care
At Christiana Care, we believe that the best medical care for tomorrow can only be developed by studying the care we give today, learning from it and proposing improvements to it. This is the essence of clinical research. Christiana Care participates in clinical research programs of high quality, and may invite patients or members of our community to join with us.

All participation in clinical research at Christiana Care is voluntary. We have an active scientific, ethical, safety and patient rights program (link to IRB) that works to select and undertake only the best projects. Much of the clinical research we undertake is as part of large, national, cooperative studies to identify new treatments for a number of diseases. Our physicians and staff may also design specific research studies at our institution. You can learn more about these by visiting the linked pages. I invite you to learn more about clinical research at Christiana Care, and to contact me, or any of the research programs on the linked pages to become more familiar with us.

Brian W. Little, M.D., Ph.D.
Vice President for Academic Affairs & Research
brlittle@christianacare.org
302-733-1042

Click here for more on medical research.
Click here for information on the benefits of joining a research clinical trial.
Click here for more information on how to join a clinical research study.
Click here to learn more about being a research volunteer.
Click here to learn more about "informed consent."
Click here to learn about randomized trials.
Click here to learn about Christiana Care's Institutional Review Board.
Click here to learn about patient confidentiality.
Click here to learn how new drugs are tested and approved.
Click here for current clinical research trials listed by medical specialty.
Click here for related sites of interest.

What kinds of research studies are there?
Some research studies look at statistical information gathered by studying population records. Clinical trials need volunteers to assist in different types of studies.

For example, prevention trials test new drugs or techniques designed to prevent the development of a particular disease or condition in people at risk.

Control trials test treatments for the symptoms and side effects caused by disease and examine quality of life issues.

Treatment trials test the effectiveness of new therapies and drugs.

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Why join a research clinical trial?
If you have a medical condition, being part of a research clinical trial may actually give you an advantage. You'll benefit from increased medical attention and support from doctors and nurses who are committed to finding new and better ways to prevent and treat your illness. You may even qualify for free medical therapy. Many doctors find that, in general, their patients do better overall, both medically and psychologically, when they take part in scientific studies designed to evaluate a new treatment for their illness.

You may want to participate for other reasons as well. Some clinical trials need healthy participants to help researchers find better methods of diagnosing or treating a disease. Clinical trials also need people who are at risk for certain illnesses or conditions to help researchers find ways to prevent the disease from developing as well as new techniques or technologies to catch the disease early at its most curable stages. Whatever the reason, by participating in a clinical trial you can make an important contribution to the future of medicine.

What does it mean to be a research volunteer?
Participation in any medical research trial is completely voluntary. During the course of the study, you may be told of new findings, benefits or risks. At that time, you may decide to leave the study. It is your choice to participate or to leave a study at any time, including after the study has started or during follow-up.

If you do not wish to take part in a study or if you decide to stop participating after the study has begun, know that your decision will in no way interfere with the quality of medical care you receive.

What are some benefits of joining a research study?
Being part of a clinical research trial can offer you some of the following benefits:

• The very latest medicines or devices available to treat your condition.
• Frequent and thorough medical exams.
• The latest information to help you better understand your condition and the guidance you need to improve your health.
• Support and counseling from doctors and nurses on Christiana Care's research staff.

Find out more about joining a research clinical trial.
To find out more about how you may benefit from a new medication or treatment available through Christiana Care's research program, ask your doctor or call the phone number listed under each medical research specialty. A research nurse will thoroughly review the trial with you, including:

• Its purpose.
• The type of treatment you'll receive.
• Any alternative treatments.
• The treatment schedule.
• Tests or monitoring involved.
• Possible side effects or risks.
• Possible benefits.
• Your obligations as a participant and your rights as a research volunteer.
• Costs to you and/or your insurance company.

What is informed consent?
When you volunteer to join a clinical trial, you will also be asked to give your "informed consent." Your signature on the informed consent form says that you voluntarily agree to participate and that you understand the key facts about the research study, including what will take place in the study and how it might affect you. A research nurse will discuss the research study with you, answer any questions you may have, and help you fill out the informed consent form. You may need approval from both your primary care physician and your specialist (if you have one) to participate in a clinical research study.

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What are randomized trials?
In some research trials, participants are randomly assigned to a treatment plan. Randomization is like flipping a coin or pulling a number from a hat. You have an equal chance of being assigned to any of the treatment options being tested (or to receive a placebo, or sugar pill, instead of the drug being researched). Because medical research must be kept very scientific, you cannot pick which protocol you want to be assigned to in a randomized trial.

What about participants' rights and safety?
At Christiana Care, all studies are first approved by the Institutional Review Board (IRB), a special committee that reviews and oversees all research projects to ensure that participants' rights and welfare are protected. The IRB includes doctors, nurses and other health care professionals, research scientists and community members.

The IRB reviews each study to make sure it is safe and reasonable to ask for volunteers and that any associated risks are as small as possible. The IRB continues to monitor the study as it progresses to make sure volunteers are protected.

Will my records be kept confidential?
Yes. Your medical records and your study records will be kept confidential. Information about your medical or study records will only be given to the researchers conducting the study or to those responsible for making sure the study is safe and following approved procedures. These groups would include members of the research staff, the Institutional Review Board, the company or group funding the study and the appropriate government agencies who oversee the study. Your records can provide important information to these review groups about whether the study is following acceptable research practices.

How are new drugs tested and approved?
On average, it takes 15 years before a drug tested in the laboratory can be tested on humans. Only five in 5,000 compounds tested in the lab ever make it to human testing. Only one in five of those are approved for sale in the United States. After initial laboratory and animal studies, medicines that are tested in people must follow rigid guidelines set by the U.S. Food and Drug Administration (FDA). Medical research studies are categorized in four phases:

Phase I clinical trials involve healthy volunteers. These trials are designed to test a drug's safety and to determine how it works in the human body.

Phase II studies test the effectiveness of the drug on a few hundred volunteer patients who have the disease the drug is designed to treat.

Phase III trials involve several thousand volunteer patients who are closely monitored in clinics and hospitals to confirm the effectiveness of the drug in treating their illness and to identify any adverse effects.

Phase IV trials are sometimes required by the FDA to evaluate any long-term effects of a drug or treatment.

Research Specialties at Christiana Care
At Christiana Care, research is a key element to providing quality health care in every medical specialty. There are hundreds of multicenter national, regional and locally based studies in progress lead by Christiana Care investigators on our hospital campuses and other patient care facilities, as well as at affiliated hospitals throughout the state. Many research trials are open for enrollment. Your help is critical to their success. For more information on research programs at Christiana Care, click on any one of the following medical specialties.

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Cancer Research
Cardiovascular Research
Diabetes and Metabolic Diseases Research
Infectious Disease Research
Trauma/Surgery/Critical Care Research