- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
