1. What is the National Institutes of Health (NIH) Clinical Center?

The NIH Clinical Center in Bethesda, Maryland, is the research hospital for the NIH, the Federal Government’s principal agency for biomedical research. The NIH Clinical Center is actually made up of two centers: the Warren Grant Magnuson Clinical Center and the Mark O. Hatfield Clinical Research Center. The NIH Clinical Center as a whole promotes translational research—that is, the transformation of scientific laboratory research into applications that benefit patient health and medical care. At the Center, patient care units are in close proximity to cutting-edge technologies and laboratories doing related research. This “bench-to-bedside” approach facilitates interaction and collaboration among clinicians and researchers. The Clinical Center supports clinical trials conducted by the 27 Institutes and Centers of the NIH, including the National Cancer Institute (NCI). More information about the NIH Clinical Center is available on the Center’s Web site at http://clinicalcenter.nih.gov on the Internet.

2. Who can participate in NCI cancer clinical trials at the NIH Clinical Center?

To enter a trial, each prospective participant needs to meet specific medical eligibility requirements. The participant and/or the participant’s health care provider are asked to provide detailed medical information. Because participant safety is of the highest concern, the NCI principal investigator and the research team make the final decision about enrolling a person during the screening visit.

3. Can cancer patients who live outside the United States participate in NCI clinical trials at the NIH Clinical Center?

Yes. People from other countries can participate in clinical trials at the NIH Clinical Center if they meet the trial’s specific medical eligibility requirements. Due to limitations on resources and funding, however, U.S. citizens and lawful permanent residents have priority for participation in these trials.

International patients planning to travel to the United States for cancer treatment should contact the U.S. Embassy or Consulate in their home country for visa eligibility and application procedures. Participants must pay for their own travel to the United States, and they must have a place to stay while they are in the United States.

4. How much does it cost to participate in a clinical trial at the NIH Clinical Center?

There is no charge for medical care received at the NIH Clinical Center. Participants will be responsible for costs for travel to their initial screening visits. In most cases, once a participant is enrolled in a trial, NCI will pay for the transportation costs for all subsequent trial-related visits for participants who do not live in the local area. In addition, these participants will receive a small per diem for food and lodging expenses if they are being treated as outpatients. However, it is important for participants to maintain current health insurance for medical care required outside of the trial.

Participants who live outside the United States are responsible for all travel costs to the United States, including the initial visit and all subsequent visits.

5. How can cancer patients enter a clinical trial at the NIH Clinical Center?

Health care providers can make referrals by following the procedures outlined below:

• Identify trials appropriate for the patient by reviewing the trial information available at http://bethesdatrials.cancer.gov/clinical-research/index.asp on the Internet.
  
  
• Contact a member of the research team listed on the trial summary of a particular trial to discuss a screening visit, or to request more information.

Or

• Call the Clinical Trials Referral Office (CTRO) at 1–888–624–1937 weekdays between 9:00 a.m. and 5:00 p.m., Eastern time, to find out whether a clinical trial is available for a specific type of cancer. Individuals who live outside of the United States may contact the CTRO by e-mail at ncicssc@mail.nih.gov.
  
  
• The CTRO staff will conduct a trial search and assist in the preliminary evaluation of eligibility, based on the patient’s medical information provided.
  
  
• The CTRO staff may either forward the prospective participant’s information to the research teams of appropriate trials, or provide the patient or health care provider with contact information for appropriate investigators.
  
  

If the patient is eligible for a trial, the research team will call the health care provider or patient to discuss procedures further. Before enrolling in a clinical trial:

• Patients should review the information with their health care provider to decide which study, if any, to consider further.
  
  
• Patients who meet the initial medical eligibility requirements may be asked to schedule an appointment at the NIH Clinical Center. During this appointment, patients learn more about the clinical trial and may also be asked to undergo some tests.
  
  
• Before agreeing to take part in the trial, patients need to understand key information about the clinical trial, including details about the treatment, tests, and possible risks and benefits. After discussing all aspects of the trial, patients receive an informed consent form to read and sign.
  
  
6. What is informed consent?

Informed consent is an ongoing process during which information is presented that enables a person to decide voluntarily whether to begin or to continue to participate in a clinical trial. During the informed consent process, the participant is told about the purpose of the trial, the risks and benefits, the procedures, the schedule, the alternatives to participation, and other important details of the study. Once a person decides to enter a trial, he/she is asked to read, sign, and date an informed consent document. This document contains a summary of the clinical trial and explains the rights of the participant. The participant should be given a copy of the signed document.

The informed consent process does not stop when the informed consent document is signed, but continues throughout the trial. Participants are given any information necessary to help them decide whether to stay in the trial. Participants have many opportunities to ask questions about the trial and about information that may be learned during the trial or from other research.

More information about informed consent can be found on the NCI’s Web site at http://www.cancer.gov/clinicaltrials/conducting/informed-consent-guide on the Internet.

7. What other safeguards are built into the process to protect the health, rights, and privacy of participants?

Every effort is made to protect and promote the welfare of the participant, and to provide the best medical and nursing care possible. Research needs may require longer periods of hospitalization than would be expected for standard treatment. NIH Clinical Center participants may also have more examinations and tests than are usually given, and follow-up examinations are often required because of the nature of the studies.

All participants at the NIH Clinical Center are protected by the Patient’s Bill of Rights. This bill ensures that medical records remain private and are not disclosed or released without the participant’s consent. In addition, each trial is carefully reviewed for risks and merit by the NCI Institutional Review Board (IRB), which includes doctors, researchers, and community leaders. IRBs check to see that the trial is well designed, legal, and ethical; does not involve unnecessary risks; and includes safeguards for patients. No test or treatment is ever given that is unnecessarily hazardous to the participant. The participant is always free to decline to participate in any aspect of the study at any time. Researchers will stop any trial if unexpected problems arise.

8. How is the referring health care provider kept informed of patient care and progress during the trial?

The NCI and the referring health care provider coordinate patient care. The NCI principal investigator discusses the trial and treatment with the patient’s health care provider upon receiving a referral. Once a patient is enrolled in a trial, the investigator will send updates and test results at regular intervals.

NCI encourages health care providers to continue open communication with their patients throughout the clinical trial. Patients are encouraged to share their clinical trial experience with their health care providers. Referring health care providers are welcome to call the NCI research team at any time to discuss patient treatment plans and care.

9. Why are clinical trials important?

Studies of new treatment approaches may lead to the development of more effective cancer treatments, or treatments that have fewer side effects. If a new treatment proves effective in a clinical trial, not only does it benefit the trial participants, but it can become a new standard of care that may help other people with cancer. Due to progress made through clinical trials, many people with cancer are cured and many others have longer, more comfortable lives. However, it is important to recognize that treatments under study do not always turn out to be more effective than the standard treatment.

Trials that look at new ways to detect, prevent, or delay cancer, or to improve the well-being of cancer patients also make an important contribution. The results from these studies can help reduce deaths from cancer by identifying better ways to find cancer early, when it is usually easier to treat, and by finding ways to reduce the risk of developing cancer. They also provide insights into ways to improve the quality of life for people who are being or have been treated for cancer.

10. What other services are provided by NCI at the NIH Clinical Center?

The following branches of NCI study specific types of cancer at the Clinical Center, provide various types of support and care, and have their own contact information:

• The Pediatric Oncology Branch (POB) conducts clinical trials for a wide variety of childhood cancers at the NIH Clinical Center. To refer children, teenagers, or young adults, the patient’s health care provider should contact the POB office at 1–877–624–4878 between 8:30 a.m. and 5:00 p.m., Eastern time. The attending physician will discuss the case with the patient’s health care provider, determine eligibility for treatment under a clinical protocol, and help arrange the referral. Once the patient has been accepted for evaluation, a social worker from the POB will contact the family and provide information on the study, as well as details about travel and lodging. More information about the POB can be found at http://home.ccr.cancer.gov/oncology/pediatric/ on the Internet.

  Attending physicians in the POB are also available to provide a second opinion. The patient, family member, or health care provider can contact the POB to talk about a diagnosis or treatment plan.

• The Neuro-Oncology Branch (NOB) offers clinical trials as well as consultations for children and adults with brain tumors. Staff can provide a second opinion for doctors, patients, and family members who are interested in this service. Specialists can either evaluate the patient in person or review the patient’s medical records and scans.

  To find out more about this service, and what information is needed, contact the Neuro-Oncology Branch at 301–594–6767 or 1–866–251–9686 (toll-free) between 9:00 a.m. and 6:00 p.m., Eastern time. The Neuro-Oncology Branch’s Web site can be found at http://home.ccr.cancer.gov/nob on the Internet.

• The Immunotherapy Service of the Surgery Branch conducts clinical trials for melanoma. The patient, family member, or health care provider can get information about these studies by calling the Immunotherapy Referral Office at 1–866–820–4505 or 301–451–1929 between the hours of 8:30 a.m. and 5:30 p.m., Eastern time. A member of the study team is available to discuss open studies for which the patient may be eligible. If a patient is thought to be eligible, their health care provider will be asked to send medical records and scans. A screening visit is scheduled only after all the information is received and reviewed. The Surgery Branch does not offer consultations or second opinions for patients. More information about the Surgery Branch can be found at http://ccr.cancer.gov/labs/lab.asp?labid=93 on the Internet.

• The Urologic Oncology Branch offers consultations for patients who have been diagnosed with renal or localized prostate or bladder cancer and who have not had surgery. Health care providers and patients may call 301–496–6353 between the hours of 7:30 a.m. and 5:00 p.m., Eastern time. After speaking with the physician, the patient may be asked to come in for a screening visit. Surgery and/or referral to clinical studies will be offered if appropriate. More information about the Urologic Oncology Branch can be found at http://ccr.cancer.gov/labs/lab.asp?labid=92 on the Internet.

• The Thoracic Group of the Surgery Branch conducts clinical trials for esophageal cancer, lung cancer, pleural mesothelioma, and lung metastasis. Patients and health care providers may call 301–451–1233 between 6:00 a.m. and 2:30 p.m., Eastern time, to receive information about available trials and eligibility requirements. Messages can be left 24 hours a day. Consultations and second opinions may be offered to patients and health care providers. If a patient is interested in participating in a trial, all medical records must be sent to the team. The patient’s case will then be reviewed by a physician on staff and, if the patient is thought to be a likely candidate, a screening visit will be scheduled. Additional information about the Surgery Branch can be found at http://ccr.cancer.gov/labs/lab.asp?labid=93 on the Internet.

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Related Resources

• National Cancer Institute Fact Sheet 1.2, The National Cancer Institute Cancer Centers Program ¹
• National Cancer Institute Fact Sheet 1.21, Care for Children and Adolescents With Cancer: Questions and Answers ²
• National Cancer Institute Fact Sheet 1.4, NCI’s Clinical Trials Cooperative Group Program ³
• National Cancer Institute Fact Sheet 2.11, Clinical Trials: Questions and Answers ⁴
• National Cancer Institute Fact Sheet 7.47, How To Find a Doctor or Treatment Facility If You Have Cancer ⁵

National Cancer Institute (NCI) Resources

Cancer Information Service (toll-free)

Telephone: 1–800–4–CANCER (1–800–422–6237)

TTY: 1–800–332–8615

Online

NCI’s Web site: http://www.cancer.gov
LiveHelp, NCI’s live online assistance:
https://cissecure.nci.nih.gov/livehelp/welcome.asp

Glossary Terms

Cancer that forms in tissues of the bladder (the organ that stores urine). Most bladder cancers are transitional cell carcinomas (cancer that begins in cells that normally make up the inner lining of the bladder). Other types include squamous cell carcinoma (cancer that begins in thin, flat cells) and adenocarcinoma (cancer that begins in cells that make and release mucus and other fluids). The cells that form squamous cell carcinoma and adenocarcinoma develop in the inner lining of the bladder as a result of chronic irritation and inflammation.

The growth of abnormal cells in the tissues of the brain. Brain tumors can be benign (non-cancerous) or malignant (cancerous).

A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord.

Having to do with the examination and treatment of patients.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical trial.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.

To heal or restore health; a treatment to restore health.

The process of identifying a disease, such as cancer, from its signs and symptoms.

Cancer that forms in tissues lining the esophagus (the muscular tube through which food passes from the throat to the stomach). Two types of esophageal cancer are squamous cell carcinoma (cancer that begins in flat cells lining the esophagus) and adenocarcinoma (cancer that begins in cells that make and release mucus and other fluids).

Monitoring a person's health over time after treatment. This includes keeping track of the health of people who participate in a clinical study or clinical trial for a period of time, both during the study and after the study ends.

Treatment to boost or restore the ability of the immune system to fight cancer, infections, and other diseases. Also used to lessen certain side effects that may be caused by some cancer treatments. Agents used in immunotherapy include monoclonal antibodies, growth factors, and vaccines. These agents may also have a direct antitumor effect. Also called biological response modifier therapy, biological therapy, biotherapy, and BRM therapy.

A group of scientists, doctors, clergy, and consumers that reviews and approves the action plan for every clinical trial. There is an Institutional Review Board at every health care facility that does clinical research. Institutional Review Boards are designed to protect the people who take part in a clinical trial. Institutional Review Boards check to see that the trial is well designed, legal, ethical, does not involve unneccesary risks, and includes safeguards for patients. Also called IRB.

A researcher in a clinical trial or clinical study.

Restricted to the site of origin, without evidence of spread.

Cancer that forms in tissues of the lung, usually in the cells lining air passages. The two main types are small cell lung cancer and non-small cell lung cancer. These types are diagnosed based on how the cells look under a microscope.

A form of cancer that begins in melanocytes (cells that make the pigment melanin). It may begin in a mole (skin melanoma), but can also begin in other pigmented tissues, such as in the eye or in the intestines.

A benign (noncancerous) or malignant (cancerous) tumor affecting the lining of the chest or abdomen. Exposure to asbestos particles in the air increases the risk of developing malignant mesothelioma.

The spread of cancer from one part of the body to another. A tumor formed by cells that have spread is called a “metastatic tumor” or a “metastasis.” The metastatic tumor contains cells that are like those in the original (primary) tumor. The plural form of metastasis is metastases (meh-TAS-tuh-SEEZ).

The National Cancer Institute, part of the National Institutes of Health of the United States Department of Health and Human Services, is the Federal Government's principal agency for cancer research. The National Cancer Institute conducts, coordinates, and funds cancer research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer. Access the National Cancer Institute Web site at http://www.cancer.gov. Also called NCI.

A federal agency in the U.S. that conducts biomedical research in its own laboratories; supports the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helps in the training of research investigators; and fosters communication of medical information. Access the National Institutes of Health Web site at http://www.nih.gov. Also called NIH.

The study of cancer.

Having to do with children.

Medical doctor.

A thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity. It protects and cushions the lungs. This tissue secretes a small amount of fluid that acts as a lubricant, allowing the lungs to move smoothly in the chest cavity while breathing.

A gland in the male reproductive system. The prostate surrounds the part of the urethra (the tube that empties the bladder) just below the bladder, and produces a fluid that forms part of the semen.

An action plan for a clinical trial. The plan states what the study will do, how, and why. It explains how many people will be in it, who is eligible to participate, what study agents or other interventions they will be given, what tests they will receive and how often, and what information will be gathered.

The overall enjoyment of life. Many clinical trials assess the effects of cancer and its treatment on the quality of life. These studies measure aspects of an individual’s sense of well-being and ability to carry out various activities.

A picture of structures inside the body. Scans often used in diagnosing, staging, and monitoring disease include liver scans, bone scans, and computed tomography (CT) or computerized axial tomography (CAT) scans and magnetic resonance imaging (MRI) scans. In liver scanning and bone scanning, radioactive substances that are injected into the bloodstream collect in these organs. A scanner that detects the radiation is used to create pictures. In CT scanning, an x-ray machine linked to a computer is used to produce detailed pictures of organs inside the body. MRI scans use a large magnet connected to a computer to create pictures of areas inside the body.

A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

A professional trained to talk with people and their families about emotional or physical needs, and to find them support services.

In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with the standard of care. Also called best practice and standard therapy.

A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.

Having to do with the chest.