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Clinical Trials

Because Mount Sinai Medical Center is affiliated with Columbia University and because physicians come to train at Mount Sinai, our cancer patients have unique access to clinical trials.

Clinical trials are tightly regulated scientific studies to determine if new therapies or treatment approaches are safe, effective, and possibly better than current options. Most of the greatest cancer breakthroughs have been made through the clinical trial process, which is why these types of studies are considered the “gold standard” for evaluating new therapies.

Participants in clinical trials have unique access to the latest, most advanced approaches for their type of cancer; however, it’s important to know that often patients who enroll in clinical trials may not receive the drug or treatment that is being studied. Instead, they may receive the standard of care to determine if the current approach is better, just as good, or less effective compared to the treatment being studied.

Types of Clinical Trials
Benefits of Clinical Trials
Clinical Trials at Mount Sinai

Types of Clinical Trials

There are four phases of clinical trials:

Phase I

Phase I clinical trials are used primarily to test the safety of new treatments. These studies, which usually only have a small number of participants, also are used to evaluate possible side effects and to determine how to use the new treatment. For example, whether a new drug should be delivered by itself or in combination with another drug. Cancer patients at Mount Sinai do not typically participate in Phase I studies, since this phase of trials is the most experimental.

Phase II

Phase II trials involve far more participants than Phase I trials. Like Phase I studies, these trials are also designed to evaluate safety. Most importantly, though, Phase II clinical trials also evaluate the effectiveness of new treatments. They help answer the question, “Does this new therapy work?” Mount Sinai Medical Center currently has several Phase II cancer-related clinical trials underway.

Phase III

Phase III studies are the final step prior to seeking regulatory approval for a new treatment from organizations like the Food & Drug Administration (FDA). These trials include large populations of patients – sometimes several thousand – and can last for many years. During Phase III trials, scientists, also called investigators, can identify additional side effects that may not have been seen among participants in Phase II trials. In addition, Phase III trials compare a group of patients receiving the current standard of care with a different group of patients who are receiving the new, investigational treatment. This is the best way to evaluate the effectiveness of one approach to another. Cancer patients at Mount Sinai Medical Center may be eligible for participation in Phase III clinical trials to access newer treatments currently in development.

Phase IV

Phase IV clinical trials happen after a new treatment has been approved by the FDA or some other regulatory organization. The purpose of this phase of trials is to continue to check on the long-term safety and effectiveness of new treatments.

Benefits of Clinical Trials

Clinical trials offer cancer patients, as well as patients with other diseases and conditions, an opportunity to take advantage of the newest, most advanced treatments for their disease. Clinical trials are tightly regulated by the government to ensure that patient safety is protected and to make sure every patient involved in a clinical trial receives the standard of care – at minimum.

For some patients who have few options, clinical trials offer an additional source of hope for a cure from their cancer, longer lives, and a better quality of life. In addition to direct benefits patients may gain from participating in a clinical trial – including the possibility of better results from their treatment – participants can feel good knowing they are playing an important part towards advancing scientific discovery and making progress toward better, more effective treatments for cancer.

Clinical Trials at Mount Sinai

Thanks, in part, to our affiliation with Columbia University, cancer patients at Mount Sinai Medical Center have access to more clinical trials for more types of cancer than at any point in our history. Currently, Mount Sinai’s cancer experts serve as investigators for both Phase II and Phase III clinical trials for the following types of cancer:

  • Breast Cancers
  • Gastrointestinal Cancers, including Colon & Rectal Cancers
  • Urological Cancers
  • Gynecological Cancers
  • Head and Neck Cancers
  • Lung Cancers

To see the specific cancer-related clinical trials currently underway at Mount Sinai, use the search tool below:

Oncology Research

Disease Site

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Kfir Ben David

Kfir Ben-David, MD

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Akshay Bhandari, MD

Co-Chief, Columbia University Division of Urology at Mount Sinai Medical Center

Director, Robotic Surgery

Assistant Professor at the Columbia University Division of Urology at Mount Sinai Medical Center

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Alan M Nieder, MD

Co-Chief, Columbia University Division of Urology at Mount Sinai Medical Center

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Associate Professor at the Columbia University Division of Urology at Mount Sinai Medical Center

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Irman Forghani, MD, FACMG

Director of Genetics at Mount Sinai Medical Center

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