What is a Clinical Protocol?
A protocol is a study on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests; as well as procedures, medications, dosages, and the length of the study.
Participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of treatments.
The Cancer Center’s comprehensive clinical research program offers innovative, high-quality, treatment protocols for various types of cancers, including cancers of the breast, lung, ovaries, colon/rectum, stomach, kidney, head and neck, prostate, pancreas, as well as multiple myeloma, non-Hodgkin’s lymphoma and leukemia.
For information about ongoing protocols, please contact our Research Assistant at 845-362-1750, Ext. 1304. Visit cancer.org for information about other clinical trials not available at Montefiore Nyack Hospital.
What are Clinical Trials?
Clinical trials are used to determine if new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find effective cancer treatments.
Why Are Clinical Trials Important?
Clinical trials are important for two reasons:
- If a new treatment proves effective in a study, it may become a new standard treatment that can help many patients.
- Patients who take part in a clinical trial may be helped by the treatments they receive.
Clinical trials are divided into different phases. Each phase answers different questions about the new treatment.
- Phase I: In Phase I, researchers determine the best way to administer a new treatment (e.g., orally, by injection, or IV drip), how often to administer the treatment, and the safest, most effective doses. Researchers also watch for harmful side effects.
- Phase II: This phase focuses on the anticancer effects of new treatments (e.g., does the treatment shrink tumors or improve blood results?)
- Phase III: In Phase III trials, patients are randomly assigned to receive either the new treatment or standard treatment. Researchers then compare the results of people taking the new treatment with results of people undergoing standard treatments. Researchers will look at which group has better survival rates and fewer side effects among other data points.
- Phase IV: This phase is for researchers to determine additional information about the treatment, including its benefits, optimal use, side effects, and risks.
Should You Take Part in a Clinical Trial?
Only you, your loved ones, and your physician can determine whether you should take part in a clinical trial. Participation may provide access to new research treatments before they are widely available, and help others by contributing to medical research.
Benefits of Clinical Trials
- Clinical trials offer cutting-edge, high-quality cancer care.
- If a new treatment approach is proven to work and you are taking it, you will be among the first to benefit.
- You are taking an active role in a decision that affects your cancer treatment and your life.
Health insurance and managed care providers do not always cover all related patient costs in a clinical trial. Be sure to talk to a doctor from the study about what costs you will be responsible for.
Your Rights in a Clinical Trial
You have certain rights before and during a clinical trial. Knowing your rights can help protect you from harm and help you make an informed decision.
- Taking part in a clinical trial is entirely your decision. It may be only one of numerous treatment options. Be sure to discuss all options with your doctor.
- If researchers determine that a treatment may be harmful to you, you will be taken off the trial right away. You may then receive other treatments from your doctor.
- You have the right to leave a clinical trial at any time.
Where to Find Clinical Trials?
For more information about clinical trials and your rights, visit the National Cancer Institute’s (NCI) website.