Services

Clinical Trials

Clinical trials are organized research studies designed to advance medical knowledge and provide information to improve disease prevention, detection and treatment. These studies compare standard therapy with new therapies to evaluate if the newer treatment is more effective in treating the disease. Many advances in the treatment and early detection of diseases such as breast cancer are the result of clinical trials. North Shore- LIJ Health System is nationally recognized by the National Cancer Institute and conducts many clinical trials.

Various types of cancer clinical trials study ways to prevent, detect, diagnose, control and treat cancer. Others focus on the psychological impact of cancer and the quality of life of patients during their treatment.

Prevention Trials: are designed to determine the best way to prevent cancer in people who have never had cancer, or to prevent cancer from coming back, or a new type of cancer from occurring in persons who have already had cancer.

Screening (Early Detection) Trials: determine the best ways to find cancer in its earliest stage.

Treatment Trials: test new therapies (such as new drugs, new combinations of drugs, new approaches to surgery or radiation therapy) in people who already have cancer.

Quality-of-life Trials: study ways to improve comfort and quality of life for cancer patients.

Most clinical research is carried out in steps, or phases . Each phase is designed to determine different information.

PHASE I TRIALS: After drugs are tested in the laboratory and on animals, this phase is used to determine the best way a new drug should be administered (orally, intravenous or injection) at what dose (initially given at low doses ), how often it should be given and what the side effects are. Only a small number of patients are enrolled into these trials.

PHASE II TRIALS: While continuing to evaluate the safety of the drug, this phase helps determine the response or how well the drug is working. It usually focuses on a particular type of cancer. The subject is closely monitored during treatment for anti-cancer effects of the drug. Approximately 20 –50 patients participate in these trials.

PHASE III TRIALS: This phase compares a promising new drug, combination of drugs or procedure with the current standard of treatment. It requires a large number of participants who are randomly assigned to receive either the standard treatment (control group) or the treatment or drug being studied. Researchers can then compare the two types of treatment to determine if the new treatment is more beneficial to survival and quality of life.

Eligibility to participate in clinical trials is very specific and depends on a number of different factors. This may include the type of cancer; any previous treatments; health history; and results of specific lab tests. It is important to remember that if you choose to participate in a clinical trial, it is VOLUNTARY and you may withdraw from the study AT ANY TIME.

There are several safety measures in place to protect the people who participate in clinical trials including review committees to ensure the protocol (plan) being followed and to minimize the risks to the participants. Among those are:

Organizations that sponsor the study, for example, the National Cancer Institute (NCI)
Institutional Review Boards (IRB) that oversees clinical research in healthcare institutions. IRBs are composed of physicians, other health care providers, consumers, and sometimes even members of the clergy, who do not have any personal interest in the results of the study. As neutral reviewers, they ensure that the study is conducted fairly and that risks to the participants are appropriate with respect to the benefits.
Phase III trials additionally have a special group called a Data Safety and Monitoring Committee

If you or someone you know are interested in participating in a cancer clinical trial, the following is a list of questions you might want to ask your health care provider:

What is the purpose of this study/trial?
How many participants are part of the study?
What types of tests and treatments are involved?
What side effects can I expect from this treatment?
How will the side effects be managed?
Will I be responsible for any costs?
How long will the study last?
What type of long-term follow-up should I expect?
Does the study require any hospitalization?
What will my responsibilities be if I decide to participate?

Anyone who chooses to participate in a clinical trial must sign an informed consent indicating that they have been informed of what will happen during the study. The form contains information specific to the study such as : the study procedures (including "treatments", monitoring of treatment effects - good and bad, etc.), types of problems that might occur, other treatments that may work for the condition and the risks and benefits of participating in the trial.

Clinical Trials for Breast Cancer Research There are many breast cancer clinical trials and studies in the United States and in other countries. They are sponsored by government agencies, healthcare organizations, private industry, and non-profit foundations all working together.

In this country, trials and studies are overseen by the government, under the auspices of the Department of Health and Human Services, National Institutes of Health, Food and Drug Administration, and other agencies. Most breast cancer trials are managed under the guidance of the National Surgical Adjuvant Breast and Bowel Project (NSABP).

At North Shore-LIJ Health System North Shore-LIJ strives to provide state-of-the-art cancer care by offering access to the newest therapies available today. Over 100 protocols or clinical trials are available throughout the Health System which are sponsored by organizations such as the National Cancer Institute and the pharmaceutical/medical technology industry.

High priority is given to studies sponsored by the National Cancer Institute (NCI). These clinical trials are available through NCI sponsored cooperative groups including the Cancer and Leukemia Group B (CALGB), National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecological Oncology Group (GOG). Through an NCI grant awarded to the Don Monti Division of Medical Oncology and Hematology at North Shore University Hospital in Manhasset, the Community Clinical Oncology Program (CCOP) disseminates and coordinates new information related to cancer treatment and the oncology patient in the community. System facilities with CCOP physicians on staff include NSUH Manhasset, Glen Cove Hospital, NSUH Plainivew, Long Island Jewish, Huntington Hospital, Southside Hospital and Staten Island University Hospital.

The Don Monti Division at Manhasset has also developed a large Pharmacology and Experimental Therapeutics (PET) Program offering clinical trials from many large pharmaceutical/medical technology companies. Areas of study include biological therapies, new chemotherapy drugs, anti-nausea medications, agents that modify drug resistance, and agents which stop cells from mutating or changing. Please refer to the NS-LIJ Breast Services section for the phone numbers for the Clinical Trials office at the various Health System facilities.

There are many clinical trials available for breast cancer through the Community Clinical Oncology Program. However, clinical trials open and close frequently so please check with the CCOP office at (516) 562-8910 for more information regarding all open studies throughout the Health System.

For more information regarding clinical trials of the PET Program, please contact Clinical Supervisor, Barbara Barile-Theim, RN at (516) 562-8977.

For more information regarding other existing clinical trials, contact the Health System facilities directly at the phone numbers below or use the e-mail link above.

NSUH at Manhasset: 516- 562-8910