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For many people, the term “clinical trial” invokes the idea of people subjecting themselves to medical treatments that are unproven, possibly unsafe and perhaps what they might even consider unwise.
Many people believe, too, that individuals participating in a trial are given either an actual drug being tested or a placebo. While this placebo effect methodology may be used in some trials, generally clinical trials compare a new product or therapy to something else to see if it works as well or better to treat or prevent a disease or condition.
Placebos are not used where a patient would be put at risk, particularly in the study of treatments for serious illnesses, by not having effective therapy. Potential participants are told before they enter a trial whether placebos are going to be used in the study.
Participation may make a difference, however. It’s important for women with breast cancer to realize that there are currently 1,973 open studies currently taking place; they may qualify for a trial that could change their life — and the lives of others.
They should also remember that a clinical trial may be looking for participants to determine ways to manage stress, discover foods that help fight disease and keep us healthy, or find which types of exercise are best for survivors. Not every trial involves medications or treatments, and not every participant needs to be facing an urgent medical issue.
Exactly what is a clinical trial?
At its most basic, a clinical trial is a research study conducted with human volunteers that is designed to answer a specific health question. When carefully managed, clinical trials can be an effective, safe and relatively quick way to discover treatments that work in people, while additionally providing new approaches for improving health and outcomes.
A clinical trial may be designed to discover:
Every clinical trial is conducted according to what is known as a protocol. In order for the information gained during a clinical trial to be relevant, the protocol has to be strictly followed. With this in mind, when creating a protocol, the researchers regulate:
Anyone entering and participating in a study will be required to agree to the rules outlined by the protocol.
Clinical trials provide researchers with ways to finding better solutions
Although many of the trials conducted are designed to see if a new drug or device is safe and effective for people to use, as we’ve discussed, a clinical trial can also be done for other reasons. Just a few examples include:
In the majority of U.S. trials, researchers, doctors, and other health professionals administer the trial according to strict rules set by the Food and Drug Administration (FDA). These rules were created by the FDA in an attempt to make sure anyone agreeing to be in the study is treated as safely as possible.
Who should volunteer and why is it so important?
Not only is it important to test drugs and medical products in the populations they are meant to help, it is also important to conduct research in a variety of people since they may respond differently to treatments. For this reason, the FDA tries to make sure that people of different ages, races, and ethnic groups are included in clinical trials in order for the outcomes to have meaning to a broader audience.
A person may participate in a clinical trial because they have exhausted standard (approved) treatment options — either because those did not work for them, or they were unable to tolerate certain side effects. Clinical trials may provide another option when standard therapy has failed.
Other people participate in trials because they want to contribute to the advancement of medical knowledge.
As we mentioned, for each clinical trial researchers develop eligibility criteria, that may include age, type and stage of disease, previous treatment history, and other medical conditions. These criteria help to reduce the amount of variation in the study, without threatening the scientific integrity of the trial, since they eliminate medical variations that could complicate analyzing the results.
Not everyone who applies for a clinical trial is accepted. A volunteer may be excluded based on the eligibility criteria, or even the number of participants needed by the researchers to collect enough information to determine the safety and effectiveness of a therapeutic agent.
Considering your safety
The FDA works to protect participants from unreasonable risks to make sure they have reliable information as they decide whether to join a clinical trial. Obviously, depending on what the trial is trying to determine, certain risks may be unavoidable since there will always be some uncertainty in medical research studies involving new medical treatments.
As a precaution, the government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Not only must participants sign an informed consent document before joining a study which indicates they understand the trial is research, but they also have the right to leave the trial at any time.
This informed consent is part of a process designed to make sure a prospective participant in a clinical trial understands what known risks might be associated with the study, and whether there are potential, but as-yet-unknown risks associated with the product being studied. This information permits people to make an informed decision about the level of risk they are willing to accept.
It is important to learn as much as possible about a clinical trial before deciding to participate. Prospective participants should feel completely comfortable discussing their questions and concerns with members of the health care team. They should also understand what happens during the trial, the type of health care they will receive, and any costs to them – which may or may not include the cost of the product, costs associated with administering the product, etc.
What benefits can a participant expect?
Participating in a well-designed and well-executed clinical trial often provides a participant the opportunity to:
You have the right to explore the possibility of entering a clinical trial and not actually participate
Sometimes people hesitate to talk to their healthcare team about clinical trials because they are afraid if they qualify they will be obligated to participate. One woman we spoke to had entertained the idea of entering an ongoing clinical trial taking place at the University of Pennsylvania where they are testing a vaccine for women with DCIS that is HER2 positive.
After undergoing a series of tests to make sure she qualified, she finally decided against participating because she felt the demands of having to fly back and forth for several weeks, trying to balance her work-life, and dealing with the realities of surgery were going to be too stressful.
When we spoke to her, she shared, “It was a fantastic study and I still wish I could have figured out how to make it work. They were willing to pay for my airfare and my housing while I was in Philadelphia, so the financial burden certainly wasn’t weighing me down. I’ve been intrigued by the possibility of vaccines being used to either cure or reverse breast cancer since I first heard about work being done at Stanford University years ago. For me it just came down to my comfort level. Every time I thought about having to fly back and forth and being in a strange place getting treatment, it just felt overwhelming. Another person probably would have jumped at the opportunity – and I hope they do!”
Finding reliable information about clinical trials for breast cancer patients
One great resource is http://www.clinicaltrials.gov/. This site contains the most up-to-date and reliable information about current trials. It provides the ability to filter your search so you can simply look for “trials for breast cancer,” or you can further refine it by searching for breast cancer and your city or state. You can also search just for trials that are currently open – which is a godsend since this keeps you from having to scroll through lists of trials that may no longer be accepting participants.
Another great site that will not only help match you with a trial that’s right for you, but also shares a wealth of information which even includes interviews with individuals who have participated in trials is BreastCancerTrials.org. BreastCancerTrials.org is a non-profit dedicated to helping provide accurate information for individuals interested in finding out about a trial, and they also help researchers and site coordinators connect more efficiently with volunteers who are interested in their studies. Additionally, they help care providers and patient navigators find trials for patients.
Clinical trials for breast cancer most certainly remind us there is no one size fits all when it comes to this disease. As with every aspect of the breast cancer journey, there is not a right or wrong approach. Every woman must make the choices that feel best in her given situation. Some women will embrace the idea of getting involved in a clinical trial if they qualify, and others will simply not feel this is the path they want to take.
Probably the most important key is having a medical team you know you can count on and trust so that if you are considering a clinical trial you will feel confident you are making the right decision.
For women who have participated in a trial, we would welcome hearing your stories, because as with all things breast cancer-related, every time we share relevant information we help someone else cut through the clutter and find the answers she is seeking.