Articles for Our Patients ~ Swapnil Rajurkar, MD, Medical Oncologist
Clinical Trials: What You Need to Know
Author: Swapnil Rajurkar, MD, Medical Oncologist • Language: ENG
Clinical trials are studies in which people volunteer to test new drugs or procedures. Doctors use clinical trials to learn whether a new treatment works and is safe for people. These kinds of studies are needed to develop new treatments for serious diseases such as cancer.
They are the best way for doctors to learn what works best in treating diseases such as cancer.
Deciding to take part in a clinical trial can be hard if you have cancer. But it is your choice to make, if there is a clinical trial for which you qualify. A lot has changed over the past few decades, and many people want to know as much as possible about all of their options before they make up their mind.
Fact: All clinical trials are voluntary
You always have the right to choose whether or not you will take part in a clinical trial. The level of care you get should not be affected by your decision. And you have the right to leave a clinical trial at any time, for any reason.
Many clinical trials test other forms of treatment, such as new surgery or radiation therapy techniques, or even complementary or alternative medicines or techniques.
Fact: When clinical trials do look at drugs, not all of them study new ones
Fact: Very few cancer clinical trials involve a placebo
What are the phases of clinical trials?
Phase 0 clinical trials: Exploring if and how a new drug works.
Phase I clinical trials: Is the treatment safe?
Phase II clinical trials: Does the treatment work?
Phase III clinical trials: Is it better than what’s already available?
Submission for FDA approval: New drug application (NDA).
Phase IV clinical trials: What else do we need to know?