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Clinical Research Program

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The Westchester Medical Center Health Network (WMCHealth) Clinical Research Center reviews and processes over 200 clinical trials and amendments per year. Within our review process we work closely with our designated Institutional Review Board at New York Medical College.

According to the National Institutes of Health, “Clinical research is the study of health and illness in people.” The goals of clinical trials are to find better ways to detect, prevent or treat diseases. Clinical trials are used to test newly developed drugs, newly developed medical devices, new surgical techniques, new therapy techniques, or new screening and diagnostic techniques. Sometimes trials evaluate new ways to use existing treatments or are used to improve the quality of life for people suffering with disease or chronic illness. Clinical trials occur in phases to establish the safety and efficacy of new treatments. 

Many people participate in clinical trials. If you are interested in participating in a clinical trial let your doctor know. You can search for available trials at ClinicalTrials.gov. You can also contact study coordinators at WMCHealth for trials we are participating in. Study coordinators can answer all of your questions about the trial and will set up a screening appointment to see if you qualify.

Please review the clinical studies at WMCHealth that are open for enrollment in your area of interest. Each study description includes eligibility requirements and contact information to learn more.

To learn more about the clinical trial process visit our FAQ or the National Institutes of Health website, What Are Clinical Trials and Studies.

Clinical Trials Now Enrolling at Westchester Medical Center

Oncology

Cellular Therapies

Neurosurgery

Cardiology

Hematology

 

Clinical Trials

Clinical trials are methods by which experimental treatments for a variety of diseases are tested on human volunteers. These treatments are deemed experimental and have not been thoroughly tested and approved for a particular indication.

The goals of clinical trials are to find better ways to treat diseases, determine if a treatment is safe and effective, and ultimately find a cure. Clinical trials are used to test newly developed drugs, newly developed medical devices such as cardiac/vascular stents or heart valves, new surgical techniques, new radiation therapy techniques, or new screening and diagnostic techniques.

The Westchester Medical Center - Office of Clinical Trials reviews and processes over 200 clinical trials and amendments per year. Within our review process we work closely with our designated Institutional Review Board at New York Medical College.

Clinical Trials FAQs


 

What are the different phases of clinical trials?

Clinical trials are performed in different phases. Each phase evaluates treatments in a slightly different way.
  • Phase I - These trials are used to determine the best dosage of a new drug to be used and if it is safe (side effects). These trials typically involve small numbers of volunteers, typically 20 to 80 people.
  • Phase II - These trials are used to determine if a drug or treatment is beneficial to patients with a specific disease and to continue to gather information about the safety of the treatment. These trials involve larger numbers of volunteers, typically around 100 to 300 people.
  • Phase III - If the drug or treatment appears promising, Phase III trials compare the experimental treatment to standard therapies that are already in use and approved by the FDA. This Phase of clinical trials tries to determine if the new drug or treatment is better than the current treatment and how the side effects of the two treatments compare.
  • Phase IV - These trials are post-marketing (After FDA approval) studies. Phase IV studies are used to gain more experience in evaluating the safety and efficacy of the drug or treatment in larger numbers of patients. These studies are also used to compare the drug/treatment with other available treatments and to evaluate the long term use of the drug/treatment.

Why are clinical trials needed?

Clinical trials are the only reliable and objective way to determine the safety and effectiveness of experimental treatments including drugs and devices. Clinical trials are also done to compare existing or "standard treatments" to determine which is better. Clinical trials are also used to determine different ways to use standard treatments so that they will be more effective with fewer side effects. Without clinical trials the life saving treatments we have today would not be available. 

Why should I consider participating in a clinical trial?

Participating in a clinical trial is certainly a personal choice and the decision should be made after receiving information about the trial and discussing the information with you physician and/or other health care providers.

People decide to participate in a clinical trial for a variety of readasons. People who volunteer to participate in a clinical trial can gain access to promising treatments long before these treatments are approved for general use. Others participate in clinical trials because they have exhausted all approved treatment options which have not worked for them or they could not tolerate the side effects of the approved treatments. Other people participate in trials because the want to contribute to the advancement of medical knowledge.

Are clinical trials safe?

For most trials, researchers, doctors, and other health professionals administer the clinical trials according to strict rules set by the Food and Drug Administration. The FDA sets the rules to make sure that people who agree to be in studies are treated as safely as possible.

In addition to the Food and Drug Administration, other processes are put in place to protect research subjects.

Each clinical trial is reviewed by a group of people called the Institutional Review Board (IRB). The clinical trial can not begin until the IRB is satisfied that the trial addresses an important scientific question and is ethically sound. IRBs are groups made up of physicians, nurses, pharmacists, administrators, and other scientists. The IRB also receives regular updates to make sure the study is being carried out as designed and that any safety issues are addressed.

To participate in a clinical trial, a patient must meet very specific eligibility requirements. In addition, an assessment of risk versus possible benefit is made. If the patient's risk is too high they may not be able to participate.

When treating patients on a study, the study team monitors participants very closely and will try to identify any potential side effects as quickly as possible. It is likely that more tests and physical exams will be performed than would have been if the patient was not participating in a clinical trial. If unexpected side effects should occur, the study team would be able to treat them quickly. In some cases patients will have to be withdrawn from the study.