For Patients

Clinical Trials.

What You Need to Know - American Cancer Society

Clinical trials are studies in which people volunteer to test new drugs or devices. 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.

A clinical trial could be an option for you. If you meet the requirements, you can decide if you want to take part in a trial.

Are Clinical Trials Safe?

This must be answered while realizing that no treatment or procedure – even one already in common use – is entirely without risk. But do the benefits of the new treatment outweigh the possible risks?

Answering these questions, while exposing as few people as possible to an unknown treatment, often requires several different clinical trials. They are usually grouped into “phases.” Clinical trials in each phase are designed to answer certain questions, while trying to make sure the people taking part are kept as safe as possible. Every new treatment is tested in 3 or more phases of clinical trials before being considered reasonably safe and effective.

New treatments have to pass many tests before they get to you. 

This is only a small part of the research that goes into developing a new treatment. Drugs of the future, for example, first have to be discovered or created, purified, described, and tested in labs (in cell and animal studies) before ever reaching human clinical trials. Of all the substances that are tested in these early stages, very few are promising enough to be tested in humans.

On average, a new cancer drug has been studied for at least 6 years before it even makes it to clinical trials. But the major holdup in making new cancer drugs available is how long it takes to complete clinical trials themselves. It takes an average of about 8 years from the time a cancer drug enters clinical trials until it is approved.

Why so long? To be sure it’s safe and effective, researchers look at each new treatment in several different studies. Only certain people are eligible (meet the requirements) to take part in each clinical trial. Cancer clinical trials take years to complete. It takes months, if not years, to see if a cancer treatment works in any one person. And figuring out if a drug really improves survival can take a very long time.

The biggest barrier to completing clinical trials is that not enough people take part in them. Fewer than 5% of adults (less than 1 in 20) with cancer will take part in a clinical trial, while 60% of children under age 15 do - this is one reason that survival rates for childhood cancer have increased so dramatically in the last few decades. The main reason people give for not taking part in a clinical trial is that they did not know the studies were an option for them. But there are many other reasons. Some people want to take part but don’t meet the requirements. Some are uncomfortable with the idea of being a volunteer in a study. Others worry that they won’t be treated fairly or could be harmed by an unproven treatment.

About Clinical Trials -

Key Messages:

  • Clinical trials enroll people in studies to help make progress in preventing, diagnosing, and treating cancer.
  • Each clinical trial follows a set of rules called a protocol that describes who can participate in the study and how the treatment will be given and monitored.
  • Governmental and non-governmental organizations may sponsor clinical trials, and people may participate in a clinical trial at a variety of hospitals and doctors’ offices.
  • The sponsor pays for many of the costs of participating in a clinical trial, but it is important to talk with your doctor about the possible costs you’ll need to pay.

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