About Research Trials

At New York Cancer Specialists we offer Phase I, II, III and IV Research Trials

Phase I trials

The purpose of a Phase I trial is to find the safest dose of a new drug that patients can receive without having harmful side effects. When participating in a Phase I trial the doctors and researchers examine the best way for a patient to receive the medication. This could be by mouth or through a vein at a research center.

Phase I trials help doctors and researchers determine if a new drug has any effect against cancer. Being Phase I trials are testing new drugs for the first time on patients the goal is to find the safest way for a patient to receive the medication and how the drug interacts with certain types of cancers.

Phase I trials usually include 1-20 patients only. Usually patients who have undergone standard treatments without success and have no other options are eligible to participate in a Phase I trial.

During Phase I trials researchers collect blood, urine and perform additional medical tests to ensure patient safety.

All data is collected and analyzed for safety and the next Phase can be opened.

Phase II trials

Phase II is to determine how well the new treatment works to fight a certain kind of cancer. Usually less than 100 patients participate in a Phase II trial. Patients who volunteer for a Phase II trial usually have had prior treatments for their disease

Phase II trials evaluate how the drug interacts with different types of cancers. Being there are more patients in Phase II trials side effects are followed very carefully. Different side effects may be noted as more patients will be involved in Phase II trials.

After all the new data is collected and the treatments seem to be effective in a certain percentage of patients, researchers may continue the study in a Phase III trial.

Phase III trials

The purpose of a Phase III trial is to compare the new treatment with the standard treatment. Researchers will collect data and track whether a new treatment is more effective, the same, or less effective than the standard treatment.

Phase III trials may include hundreds to thousands of patients. Depending how the researched are collecting information patients may receive the standard of care or the new drug being tested. This process is called randomization and all patients are monitored to ensure safety. Usually the patients and research staff are unaware of which treatment the patients receive. This ensures all testing is done the same for all patients and all the data collected is unbiased.

Phase IV trials

Phase IV trials usually occur after drug or treatment has been approved by the FDA. The drug companies can do long term data collection to ensure safety for the patients.

FDA

The U.S. Food and Drug Administration (FDA) has to make sure medical treatments are safe and effective for patients. Drug companies must do years of laboratory testing before they can begin testing medicines in humans. The FDA may or may not approve the drug or treatment. If the drug or treatment is approved then it becomes available to all patients.