The Tisch Cancer Institute (TCI) offers a wide range of clinical trials for patients with cancer. Our Clinical Research Support Unit (CRSU) offers Phase I, II, and III trials.
- Phase One clinical trials test a potential drug’s dosing, confirm effectiveness, and look for side effects.
- Phase Two trials compare the new drug, already studied in the phase one trial, to a therapy that is known to be effective, either in addition to the known therapy, or in comparison.
- Phase Three clinical trials continue to test the effectiveness of drugs that have gone through Phase One and Phase Two studies in an even larger group of patients.
Choosing to participate in a clinical trial is an important personal decision – and a voluntary one. The following information provides details about clinical trials. In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials.
What is a Clinical Trial?
Clinical trials are research studies that involve humans. These studies test new ways to prevent, detect, diagnose, or treat diseases. Many standard therapies used in cancer treatment today began as drugs that were tested in clinical trials. A clinical trial is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.
Why Join a Clinical Trial?
It is a myth that clinical trials are only for people with “no other options.” Trials provide access to promising new treatments or approaches that are often not available outside the clinical trial setting. The treatment being studied may be more effective than the current standard treatment. Results from the study may help others in the future and are key to moving the field of cancer research forward.
Who Can Participate in a Clinical Trial?
Clinical trials are appropriate for different types of people depending on the purpose and phase of the trial. Each clinical trial clearly states who can participate based on the type of cancer or other disease, prior treatments, overall health status, and a number of other factors specific to each trial. Only patients who give informed consent and meet all the eligibility criteria are entered into clinical trials.
In addition to speaking with your doctor, family members, or friends about deciding to join a trial, you could also talk to the study research staff. For more information on cancer clinical trials, visit the National Cancer Institute website.
How Do I Find a Clinical Trial at Mount Sinai?
Ask your doctor if you may be a candidate for a clinical trial. For a list of currently open cancer clinical trials at the Icahn School of Medicine at Mount Sinai, please visit the TCI Clinical Trials page.
Find a network of cancer care providers affiliated with Mount Sinai and located throughout the greater metropolitan area.
New Information for Patients Participating in Clinical Trials
At the Tisch Cancer Institute we are committed to sharing with our research patients new information about individual research studies (this is called re-consent or dissemination of research results) or how the TCI conducts cancer clinical research studies. In February 2023, a new informed consent form template document was made available to the research community. The new consent form changed standard language used throughout Tisch Cancer Institute research consent forms. The primary purpose of these changes was to use language that is more inclusive, to promote equitable research and to acknowledge subject diversity and sensitivity to differences and personal preference.
The informed consent template document modified the text in the following ways:
- Use gender-inclusive terms and expand birth control instructions
- Clarify that data and/or samples may be stored anonymously or data/samples may be coded but linked to participants
- Simplify the language describing the options for patients to indicate their preference for future use of donated data/samples for research purposes
- Remove repetitive language in the confidentiality and HIPAA authorization section
- Simplify the language that describes how to withdraw from a research study
- Add a new paragraph that outlines how the Institutional Review Board (IRB), who is responsible for human subject protections, can help research patients
- Change common research terms: “research subjects” has become “research participants” and “principal investigator” has become “lead researcher”
While these changes are largely editorial in nature, a lay summary of the consent template language is provided in this information sheet. These text modifications were not a direct result of changes associated with any particular study or your participation in the study, but rather reflect our ongoing commitment to conduct patient-focused, high quality research that meets the needs of our community.
If you have any questions about this document, or the study you are taking part in, please contact the study doctor. If you cannot reach your study doctor, please contact the Clinical Research Support Unit at 212-824-7309 or crsu@mssm.edu.
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