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FAQs for Patients

Clinical Trials

1. What is a clinical trial?
2. Why participate in a clinical trial?
3. Who can participate in a clinical trial?
4. What happens during a clinical trial?
5. What is informed consent?
6. What are the benefits of participating in a clinical trial?
7. What are the risks of participating in a clinical trial?
8. What are side effects and adverse reactions?
9. How is the safety of the participant protected?
10. What should people consider before participating in a trial?
11. What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
12. Does a participant continue to work with a primary health care provider while in a trial?
13. Can a participant leave a clinical trial after it has begun?
14. Where do the ideas for clinical trials come from?
15. Who sponsors clinical trials?
16. What is a protocol?
17. What is a placebo?
18. What is a control or control group?
19. What are the different types of clinical trials?
20. What are the phases of clinical trials?
21. What is an "expanded access" protocol?

22. What types of research are conducted at Norton Healthcare?

 

1. What is a clinical trial?

A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
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2. Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
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3. Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that do not allow someone to participate are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe.
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4. What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors, nurses, research coordinators, as well as social workers and other health care professionals. The team checks the health of the participant at the beginning of the trial, gives specific instructions for participating in the trial, monitors the participant carefully during the trial, and stays in touch after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
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5. What is informed consent?

Informed consent is the proces of learning key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Risks and potential benefits are explained in the informed consent document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
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6. What are the benefits of participating in a clinical trial?

Gain access to new research treatments before they are widely available. Obtain expert medical care at leading health care facilities during the trial. Help others by contributing to medical research. Play an active role in your own health care.
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7. What are the risks of participating in a clinical trial?

There may be unpleasant, serious or even life-threatening side effects to treatment. The treatment may not be effective for the participant. The protocol may require more time and attention than a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
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8. What are side effects and adverse reactions?

Side effects are any undesired actions or effects of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
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9. How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. Clinical research is federally regulated with built in safeguards to protect the participants. As a clinical trial progresses, researchers may report the results of the trial at scientific meetings, to medical journals and to various government agencies.
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10. What should people consider before participating in a trial?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the research team questions about the clinical trial. The following questions might be helpful for the participant to discuss with the research team. Some of the answers will be found in the informed consent document.

  • What is the purpose of the study?
  • Who is going to be in the study?
  • Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
  • What kinds of tests and treatments are involved?
  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?
  • How might this trial affect my daily life?
  • How long will the trial last?
  • Will hospitalization be required?
  • Who will pay for the treatment?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow up care is part of this study?
  • How will I know that the treatment is working?
  • Will results of the trials be provided to me?
  • Who will be in charge of my care?

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11. What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?

Plan ahead and write down possible questions to ask. Ask a friend or relative to come along for support and to hear the responses to the questions. Bring a tape recorder to record the discussion to replay later.

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
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12. Does a participant continue to work with a primary health care provider while in a trial?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
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13. Can a participant leave a clinical trial after it has begun?

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study. Certain procedures/tests may be performed when withdrawing from a trial. These are done for the safety of the participant.
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14. Where do the ideas for clinical trials come from?

Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.
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15. Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA).
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16. What is a protocol?

A protocol is a study plan that outlines the treatment and procedures for the study. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
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17. What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
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18. What is a control or control group?

A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
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19. What are the different types of clinical trials?

Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes. Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition. Screening trials test the best way to detect certain diseases or health conditions. Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
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20. What are the phases of clinical trials that involve experimental drugs?

Drug trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

  • Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
  • Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Phase IV trials, post-marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

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21. What is an "expanded access" protocol?

Most human use of investigational new drugs takes place in controlled clinical trials conducted to assess safety and efficacy of new drugs. Data from the trials can serve as the basis for the drug marketing application. Sometimes, patients do not qualify for these carefully controlled trials because of other health problems, age, or other factors. For patients who may benefit from the drug use, but don't qualify for the trials, FDA regulations enable manufacturers of investigational new drugs to provide for "expanded access" use of the drug. For example, a treatment IND (Investigational New Drug application) or treatment protocol is a relatively unrestricted study. The primary intent of a treatment IND/protocol is to provide for access to the new drug for people with a life-threatening or serious disease for which there is no good alternative treatment. A secondary purpose for a treatment IND/protocol is to generate additional information about the drug, especially its safety. Expanded access protocols can be undertaken only if clinical investigators are actively studying the new treatment in well-controlled studies, or all studies have been completed. There must be evidence that the drug may be an effective treatment in patients like those to be treated under the protocol. The drug cannot expose patients to unreasonable risks given the severity of the disease to be treated.

Some investigational drugs are available from pharmaceutical manufacturers through expanded access programs listed in ClinicalTrials.gov. The manufacturer generally manages expanded access protocols, with the investigational treatment administered by researchers or doctors in office-based practice. If you or a loved one are interested in treatment with an investigational drug under an expanded access protocol listed in ClinicalTrials.gov, review the protocol eligibility criteria and location information and inquire at the Contact Information number.

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22. What types of research are conducted at Norton Healthcare?

NORTON HEALTHCARE RESEARCH ACTIVITY

NORTON CANCER INSTITUTE
http://www.nortonhealthcare.com/ResearchandClinicalTrials
In addition to providing patients with standard therapies, Norton Cancer Institute offers a variety of innovative National Cancer Institute and industry-sponsored clinical trials in most sites and stages of disease in which patients may qualify to participate. Our participation in these research studies allows us to offer many patients the latest, most advanced therapies for cancer. Norton Cancer Institute is frequently able to provide treatments that may be unavailable elsewhere. Examples of clinical trials include angiogenesis therapy, Gynecologic Oncology Group (GOG), National Surgical Adjuvant Breast and Bowel Program (NSABP) trials. For specific information regarding active clinical trials contact the Norton Cancer Institute Research Program at (502) 629-3449.

NORTON CARDIOVASCULAR ASSOCIATES
http://www.nortonhealthcare.com/cvaky
Norton Cardiovascular Associates offers a variety of clinical trials designed to improve cardiac care. For information for cardiac clinical trials conducted by Norton Cardiovascular Associates, contact Julie Hanrahan at julie.hanrahan@nortonhealthcare.org or (502) 891-8641.

NORTON LEATHERMAN SPINE CENTER
http://www.spinemds.com/
Norton Leatherman Spine Center physicians are internationally recognized as leaders in clinical research of spinal disease, injury and deformity, and are constantly seeking new methods to improve the effectiveness of spine surgery. Award-winning research, combined with a leadership role in the University of Louisville's Department of Orthopedic Surgery, have set new standards in how physicians care for patients with spine problems. For information regarding clinical trials conducted by the Norton Leatherman Spine Center, contact Kelli Bratcher at kelly.bratcher2@nortonhealthcare.org or 502 992 0488 ext 131.

NORTON MATERNAL FETAL MEDICINE SPECIALIST
http://www.nortonhealthcare.com/mfm
Norton Maternal Fetal Medicine Specialists conduct research concerning the most recent approaches and techniques in high-risk obstetrics for optimal management of more complex pregnancies. For information about currently recruiting research studies, contact Christy Soto at Christina.waldon@nortonhealthcare.org or 502-899-6931.

NORTON NEUROSCIENCE INSTITUTE
http://www.nortonhealthcare.com/nni
Norton Neuroscience Institute is committed to advancing the fields of neurology and neurosurgery through research and clinical trials. The renowned neurosurgeons, neurologists and clinicians with Norton Neuroscience Institute are well-respected for their research. Our clinicians regularly participate in studies and publish their research and treatment findings. In return, patients of Norton Neuroscience Institute benefit from research and cutting-edge treatment not available elsewhere in our region. Through clinical studies and unique research partnerships, Norton Neuroscience Institute is dedicated to improving patient care, outcomes and quality of life. A listing of current clinical trials is found at http://www.nortonhealthcare.com/nni.cfm?id=1690 . Contact Anne Watson at (502) 629-5270 for additional information.

NORTON MULTIPLE SCLEROSIS CENTER
http://www.nortonhealthcare.com/multiple-sclerosis
The Norton Multiple Sclerosis Center has a growing research program with several new trials opening soon. A list of active clinical trials is available at http://www.nortonhealthcare.com/multiple-sclerosis-research-clinical-trial-listing and additional information may be obtained by contacting Debbie Lockridge at Deborah.lockridge@nortonhealthcare.org or (502) 899-6417.


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