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.

Fact: Not all clinical trials study treatments
Many clinical trials study new ways to detect, diagnose, or learn the extent of disease. Some even look at ways to prevent the disease from happening in the first place.
Fact: Even among clinical trials that do study treatments, not all of them study drugs
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
Even after a drug has been approved for use against a type of cancer, doctors sometimes find it works better when given a certain way or when combined with other treatments. It may even work on a different cancer. Clinical trials are needed to study these possibilities as well.

Fact: Very few cancer clinical trials involve a placebo
Placebos are rarely used alone in cancer research unless no known effective treatments exist. It’s certainly not ethical to have someone take a placebo if an effective standard treatment is already available.

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?

What protects the study participants?
Several levels of safeguards are in place* to help protect the people who take part in clinical trials. There are still risks involved with any study, but these safeguards try to reduce the risk as much as possible.
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