Here’s what you need to know about clinical trials

Clinical trials test the safety and benefits of new treatments as well as new combinations or new doses of standard treatments.  They can also study other parts of care including risk reduction, diagnosis and screening.  People volunteer to take part in these research studies.

Before a treatment is tested in a clinical trial, it’s studied in a lab.  Even though some treatments seem to work well in the lab, they don’t always work in people.  That’s why clinical trials are needed – to make sure the treatment is safe and effective for patients.


Phases of Clinical Trials

Phase 1
A phase 1 trial studies whether a new treatment is safe to use over a range of doses.  It’s mainly a drug safety study.  The treatment may be given to people with different types of cancer.
Phase 2
A phase 2 trial studies whether a drug or other therapy is an effective treatment for a certain cancer, such as breast cancer.  These trials include 25-100 people.  If a treatment is found to be effective in a phase 2 trial, a phase 3 trial will study it further.
Phase 3
A phase 3 trial studies how well a new treatment (including surgical procedures) works compared to the standard treatment or standard of care.  It studies the best way to give the new treatment to get the most benefit and whether the new treatment is better than the current standard treatment.
Phase 4
Finally, a phase 4 trial studies the long-term side effects of treatments or answers new questions about the treatment.  It’s done after a new breast cancer treatment is approved by the U.S. Food and Drug Administration.

Not all clinical trials fall neatly into one phase.  Some trials may be a combination of 2 categories, such as a phase one-two or a phase two-three trial.


Pros and Cons of Clinical Trials

There are pros and cons to consider when discussing clinical trials, which is why its imperative to discuss the risks and benefits with your doctor before signing up for a clinical trial.

Some pros are:

  • You have the chance to try a new treatment that may be better than the standard treatment.
  • Even if you do not get the new treatment, you will still get the best standard treatment available.
  • You are helping improve cancer treatment in the future by adding to research.

Some cons are:

  • The new treatment may not work as well as the standard treatment.
  • If the study is a randomized trials, you cannot choose which treatment you get, meaning you will be assigned to one treatment or another.
  • The new treatment being tested may have unexpected side effects.


Myths About Clinical Trials

MYTH #1:  If I participate in a clinical trial, I may receive a placebo.
There’s a misconception that people who participate in clinical trials may receive a placebo.  That is simply not the case.  EVERYONE who takes part in a cancer treatment clinical trial gets treated.  You will either get the new treatment being studies or the standard treatment.

MYTH #2:  Clinical trials are only for people with metastatic breast cancer.
Not true!  There are many treatment-related clinical trials for those with metastatic breast cancer, but there are also many clinical trials for those with breast cancer at all stages.  Breast cancer clinical trials study prevention, new screening tests and treatment options, as well as quality of life issues.

MYTH #3:  My doctor should decide if a clinical trial is right for me.
The person who decides if a specific clinical trial is right for you, is YOU.  Doctors should discuss the benefits and risks of clinical trials with eligible patients, but PATIENTS make the final decision.  And it’s always a good idea to get a second opinion.

MYTH #4:  You have to have breast cancer to participate in a clinical trial.
False!  Some clinical trials focus on non-treatment areas of breast cancer, such as prevention and screening.  These studies often look for people who have never had breast cancer to take part in the study.  Additionally, there are clinical trials for people who have completed breast cancer treatment to study the long-term effects of treatments, or the survival benefits of lifestyle behaviors such as diet and exercise.

MYTH #5:  Clinical trials are only available at large cancer centers.
Actually, clinical trials take place across the country and around the world in many types of medical centers, hospitals, and clinics.

MYTH #6:  Once I decide to participate in a clinical trial, I’m stuck.
Before joining a trial, a research coordinator, doctor, or nurse will review the risks and benefits of the study through a process called informed consent. You’ll get a chance to go over the study protocol, and get answers to questions you may have.  If you decide to join the study, you will be asked for your written permission on a document called a consent form.  However, consenting and giving written permission to join the study doesn’t force you to stay in the study – you may leave the trial at any time for any reason.


What’s the Cost of a Clinical Trial?

You might be wondering what the cost is to be in a clinical trial.  The cost of a new treatment or test being studied is usually paid by the organization conducting the clinical trial.  The Affordable Care Act requires insurance companies to cover non-research, standard care costs related to a clinical trial (not covered by the trial itself) plus any standard treatment given.  Before enrolling in a clinical trial, talk with your insurance provider and find out exactly which costs are covered and which are not.  This ensures you don’t have any unexpected costs, such as going to a lab or provider which may be out-of-network.


How to Find and Enroll in a Clinical Trial

Clinical trial enrollment by adults in the United States is less than 5 percent, and of these participants, fewer than 10 percent are members of racial or ethnic communities who often face higher breast cancer mortality rates.  Some of the myths we discussed earlier could contribute to those low numbers, but another major reason is that people just aren’t sure how to find a clinical trial.  That’s where Komen comes in.  We’ve helped create a collection of tools and resources to make it easy to find and enroll in clinical trials:

  1. Komen offers a helpline for those in need of clinical trial information, support, and resources.  To access the helpline, you can call 1-877-GO-KOMEN or email Clinical Trial Info dot org.
  2. Komen has collaborated with Breast Cancer Trials dot org to provide a custom matching service to help you find a clinical trial that fits your needs.  We also provide a Metastatic Trial Search Tool.
  3. By visiting Komen dot org, we have links to other websites like the National Cancer Institute and the National Institutes of Health where even more clinical trial information is available.

Considering participation in a clinical trial can seem daunting at first, but with the resources that we provide, plus the help and knowledge of your doctor, you can be armed with the information you need to make the best decision for you.