Clinical trials usually have very strict guidelines about which patients are right for the study. These include making sure you are healthy enough to take part. You may need medical tests to be considered for a clinical trial. These often are provided at no cost to you.
Your safety is our top priority. Clinical trials study new ideas about cancer treatment. Every effort is made to keep risks to a minimum, but there are risks.
Being part of a trial is a big decision. We encourage you to talk to your loved ones about it.
A doctor and study coordinator will discuss with you everything involved in a trial, including risks, and provide you with a document called informed consent that explains the clinical trial and risks in detail. You can quit a trial any time you want.
Some people hope the trial will help their cancer. Others want to be involved in helping to develop new cancer treatments and enjoy knowing they may help others down the line.
Clinical trials are classified in four phases. Most of the trials at NHRMC are phases II and III.
Phase I
A treatment is tested to determine the safe dose of a medication that can be given and study the side effects. Phase I trials are usually small.
Phase II
A treatment is tested in a group of about 35 patients who have the same type of cancer. They are given the dose of medication determined in a phase I trial. Researchers study if the patient's cancerous tumor shrinks over a period of time.
Phase III
The same treatment is tested in a trial with a larger number of patients. Some patients are given the new treatment and others are given the normal standard of care for the disease, and the results are compared.
Phase IV
Drugs approved by the FDA are studied more to learn about the side effects, longer term benefits, and best use.
A placebo is an inactive substance that looks like an actual drug but is not effective. We do not give a placebo in place of real medication for cancer patients at NHRMC unless we give both a placebo and the standard treatment, or in cases where there is no standard therapy for the disease.
You never receive treatment that is less than the normal standard of care for your cancer in a clinical trial at NHRMC.