Cancer Clinical Trials at the NIH Clinical Center
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 Clinical 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 NIH Clinical Center is devoted exclusively to clinical investigation. Unlike most facilities, the Clinical Center does not routinely provide standard diagnostic and treatment services. NIH physicians accept patients for clinical trials if the patient has an illness being studied by one or more of the Institutes and the patient meets the trial’s specific medical eligibility requirements (also called eligibility criteria).
What is NCI’s Center for Cancer Research?
The mission of NCI’s Center for Cancer Research (CCR) is to make breakthrough discoveries in basic and clinical cancer research and develop them into novel therapeutic interventions for adults and children with cancer or HIV. CCR investigators include basic, clinical, and translational scientists who collaborate with each other, with scientists at other NIH Institutes and Centers, and with scientists in academia and industry. The clinical trials conducted by CCR on the NIH campus represent the core of NCI’s intramural research program in Bethesda, Maryland.
Why are clinical trials important?
Clinical trials are the way in which new and more effective cancer treatments are discovered and proven. If a new treatment proves effective in a clinical trial, it can become a new standard of care.
Due to progress made through clinical trials, many people with cancer are living longer. However, it is important to recognize that new treatments under study do not always turn out to be more effective than the standard treatment.
What are eligibility criteria?
To enter a clinical trial, each prospective applicant must meet specific requirements, called eligibility criteria. Eligibility criteria are an important part of each clinical trial’s protocol or action plan. The criteria vary from study to study and may include age, gender, medical history, and current health status. Treatment studies often require that patients have a particular type and stage of cancer. Eligibility criteria help ensure the participants’ safety. For example, some people have other health problems that could be made worse by the treatment being studied. The qualifications also help researchers achieve accurate and meaningful results.
How can health care providers and cancer patients learn about cancer clinical trials at the NIH Clinical Center?
Information about cancer clinical trials being conducted at the NIH Clinical Center is available by phone and online.
- Call the NIH Clinical Center Patient Recruitment and Liaison Office at 1–800–411–1222.
- Visit the Search for CCR Trials at NIH page or use NCI’s clinical trials search form to identify clinical trials that may be appropriate for the patient. Review the trial information and contact a member of the research team listed in the trial summary to discuss a screening visit or to request more information.
- Contact one of the clinical research teams that study specific types of cancer at the NIH Clinical Center. Patients who meet medical eligibility requirements may be asked to schedule an appointment at the Clinical Center. During this appointment, patients will learn more about the clinical trial and may 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.
The following NCI branches study specific types of cancer at the NIH Clinical Center, provide various types of support and care, and may be contacted directly. Many provide second opinions for patients and their families.
- The Endocrine Oncology Branch conducts preclinical and clinical research and offers consultations for patients with endocrine cancers (thyroid, adrenal, pancreas, and parathyroid). Staff can provide a second opinion for health care providers, patients, and family members. Specialists can either evaluate the patient in person or provide a second opinion after reviewing the patient’s medical records and scans. For more information, call 301–496–6457 between 8:00 a.m. and 5:00 p.m. (ET).
- The Experimental Transplantation and Immunology Branch conducts clinical trials of stem cell transplant-based treatments for several types of cancer, including lymphoma, leukemia, and multiple myeloma, as well as for immune deficiency conditions that may become cancer. For more information, call 301–435–1623 between 9:00 a.m. and 5:00 p.m. (ET). A branch member will obtain relevant information by phone, may request medical records, and will discuss open trials for which the patient may be eligible. A screening visit is scheduled if eligibility criteria are met.
- The Immunotherapy Service conducts clinical trials for patients with melanoma. The patient, a family member, or a 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 8:30 a.m. and 5:30 p.m. (ET). A member of the study team can 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 will be scheduled only after all of the information has been received and reviewed. The Immunotherapy Service does not offer consultations or second opinions for patients. The Immunotherapy Service is part of the Surgery Branch.
- Multiple branches conduct medical oncology trials for patients with a variety of cancers, including lymphoma and gastrointestinal, prostate, lung, and women’s cancers. These branches are: Lymphoid Malignancies Branch, Genitourinary Malignancies Branch, Urologic Oncology Branch, Thoracic and Gastrointestinal Oncology Branch, and the Women’s Malignancies Branch. For more information, call the Medical Oncology Referral Office at 1–866–611–6310 or 301–451–1228 between 9:00 a.m. and 5:00 p.m. (ET). A member of the referral team will discuss open studies for which the patient may be eligible. If a patient is thought to be eligible, the person’s health care provider will be asked to send medical records, including scan images and pathology materials. A screening visit will be scheduled after appropriate medical information is received and reviewed. Consultations or second opinions for patients who are not eligible for trials may be provided at the discretion of the investigator.
- The Neuro-Oncology Branch offers clinical trials and consultations for patients with brain tumors. Staff can provide second opinions for health care providers, patients, and family members. Specialists can either evaluate the patient in person or offer a second opinion after reviewing the patient’s medical records and scans. To find out more about this service, call 240-760-6010.
- The Pediatric Oncology Branch conducts clinical trials for various childhood cancers. To refer children, teenagers, or young adults, the patient’s health care provider should call the branch at 301–496–4256 or 1–877–624–4878 between 8:30 a.m. and 5:00 p.m. (ET). 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. After the patient has been accepted for evaluation, a social worker from the branch will contact the family and provide information about the study, as well as details about travel and lodging.
- The Radiation Oncology Branch designs and conducts preclinical and clinical research on the biologic and therapeutic effects of radiation therapy. Clinical trials conducted by this branch involve novel technologies and/or imaging-based approaches to radiation therapy. Computed tomography and magnetic resonance (MR) image fusion are routine components of patients’ treatment plans. The Radiation Oncology Branch also provides radiosurgery, intensity-modulated 3-D conformal radiotherapy, real-time dose measurement, brachytherapy, and MR-guided procedures. To find out more about current clinical trials, patients and health care providers can call 301–451–8905 or 301–496–5457 between 8:00 a.m. and 5:00 p.m. (ET).
- The Thoracic and Gastrointestinal Oncology Branch conducts clinical trials for patients with esophageal cancer, lung cancer, pleural mesothelioma, and lung metastases (cancer that spread to the lung). Patients and health care providers may call 301–451–1233 between 6:00 a.m. and 2:30 p.m. (ET) to receive information about available trials and eligibility requirements. 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 a screening visit will be scheduled if the patient is thought to be a likely candidate for the trial.
- The Urologic Oncology Branch offers consultations for patients who have been diagnosed with renal (kidney) or localized prostate or bladder cancer and who have not had surgery. Health care providers and patients may call 301–496–6353 between 7:30 a.m. and 5:00 p.m. (ET). After speaking with a physician on staff, the patient may be asked to come in for a screening visit. Surgery and/or referral to clinical trials will be offered if appropriate.
Can cancer patients who live outside the United States participate in 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. Once a participant is enrolled in a trial, NCI will pay for transportation for 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 that is required outside of the trial or that is provided away from the Clinical Center.
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 are the participant's health, rights, and privacy protected?
Every effort is made to protect and promote the welfare of the participant and to provide the best medical and nursing care possible.
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. The purpose of the trial, its risks and benefits, the procedures, the schedule, the alternatives to participation, and other important details of the study are explained to the patient. If 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.
All participants at the NIH Clinical Center are protected by the Clinical Center Patients’ Bill of Rights. This document 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?
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.