How do your doctors make decisions about your treatment plan? In large part, information from clinical trials tells them the best medicine and dosage for you. My oncologist and I read the results of clinical trials in order to decide on an aggressive radiation plan. As patients, we depend on clinical trial research, yet only an estimated three percent of cancer patients enter trials, according to the National Institutes of Health (NIH).
There are clinical trials for patients at every phase of treatment, but there are some crucial factors to consider before you sign up for any research and some important steps to follow to make sure you have a positive experience.
Step #1. Understand what clinical trials are. The NIH explains that clinical trials use human subjects to decide how well medical procedures work. Although you may think of clinical trials as drug tests, they can evaluate all sorts of treatment methods, from exercise to massage to specific types of surgery.
Most trials will have two or more arms. Everyone receives the best standard of care, but the people in one arm of the study will also receive the investigational treatment. The best-designed clinical trials are double blind, which means that neither you nor your medical team will know what treatment you are receiving. Double blinding removes the possibility that you or your doctor will be influenced by knowing what drug you are getting. (Not every study is double blind. If you were in a study looking at whether moderate or intense exercise is better at controlling blood pressure, you would quickly figure out which arm you were in.)
It’s also important that trial participants are randomly assigned to each arm to eliminate unconscious bias on the part of the researchers. For example, in a study looking at whether lumpectomy or mastectomy is better, researchers might tend to put younger women in the lumpectomy group if they have an unconscious bias that breast conservation is more important to younger women. Both arms of the group need to be as balanced as possible for age, type of cancer, race, and other factors.
This means that even if you are interested in a clinical trial for a specific drug, you cannot be assured of getting it. Sometimes if the new treatment proves spectacularly successful, the trial is ended early so all the participants can get the new treatment. Before a clinical trial can begin, it must pass an institutional review board that looks at how participants’ health and privacy will be protected. Whether you get the new treatment or not, you will still receive the current best treatment, and you will know that your participation will help scientists.
Step #2. Talk to your doctor. Your doctor may already be participating in a trial or may know about trials that would be suitable for you. Once your doctor knows that you are interested and willing to participate, he or she can help you evaluate the advantages and disadvantages for your specific situation.
Step #3. Check out a research study data base. There are currently more than 200,000 trials for all types of health issues throughout the world listed at the NIH data base, so your doctor can’t know every trial for which you might be eligible. In fact, one study found that only 22 percent of patients ever heard about clinical trials from their doctors. ClinicalTrials.gov allows either patients or doctors to enter the type of disease and get a list of current trials.
Another database that I found extremely user-friendly is BreastCancerTrials.org. I entered my medical history and found 31 trials that matched me, someone who has finished treatment for inflammatory breast cancer. The site also uses your zip code to indicate how close the trials are to your home. There are prevention trials for people who have never had breast cancer, as well as trials for patients in every stage of treatment.
Think about your concerns. If you have a family history of breast cancer, you may be interested in trials related to prevention. If you are really worried about recurrence, look at trials investigating ways to keep cancer from coming back. Once you know what you are interested in, you can enter those topics into the database search engine to find appropriate trials.
Step #4. Ask questions! When you find a trial that matches your concerns, investigate it thoroughly. Bring a list of questions to your doctor and the researchers, including:
- Who is sponsoring the trial and how reputable are they?
- What type of trial is it? A Phase I trial is done on a small group of healthy people to see if a treatment is safe. Phase II trials evaluate if a drug is effective and safe. Phase III trials are done on larger groups of people to continue to evaluate efficacy and monitor side effects.
- Do you meet the criteria? It can be disappointing to find out that you are too old or that your tumor doesn’t match the requirements for inclusion in the trial. However, because the results will not be valid unless the control groups can be matched, scientists need to work with closely paired sets of people. Before you get too excited about a trial, read the eligibility requirements.
- What are the possible short-term and long-term risks? Although the safety of a treatment is checked in Phase I trials, there is always the possibility that the new treatment will have problems not detected in earlier stages of research. Your doctor can help you put those risks into perspective.
- What are the possible advantages?
- How will your privacy be protected?
Step #5. Know the costs and who will cover them. Generally speaking, your insurance will cover the routine costs that you would have incurred during the ordinary course of treatment, and the researchers will cover the cost of the investigational drugs or procedure. However, sometimes people get caught in the middle. Is that extra scan a routine cost your insurance should cover, or an expense the trial should cover? Most of the time, travel expenses and child care are not covered, so you need to factor those in and ask if there are any stipends available to help with those costs.
Step #6. Be proud of your willingness to advance breast cancer research. Whether you end up actually participating in a trial or not, you can be proud of yourself because you are willing to add to the knowledge that will help other people. Without volunteers willing to take a risk, our doctors wouldn’t know how to help us.
See More Helpful Articles:
BreastCancerTrials.org: Find a trial that’s right for you. https://www.breastcancertrials.org/bct_nation/home.seam?cid=34957
ClinicalTrials.gov.: A service of the U.S. National Institutes of Health. https://clinicaltrials.gov/ct2/home
Notice of Revised NIH Definition of “Clinical Trial.” October 23, 2014. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html
Poll: Majority of Americans would participate in clinical trials if recommended by their doctor. Elsevier. July 31, 2013. https://www.elsevier.com/connect/poll-majority-of-americans-would-participate-in-clinical-trials-if-recommended-by-doctor
Phyllis Johnson is an inflammatory breast cancer survivor who serves on the Board of Directors for theInflammatory Breast Cancer Research Foundation, the oldest 501(3)© organization focused on research for IBC. She is a list monitor for an online support group atwww.ibcsupport.org. She stays current on cancer information through attendance at conferences such as the National Breast Cancer Coalition’s Project LEAD® Institute. A retired teacher, she has been writing about cancer issues at HealthCentral since 2007.
Phyllis Johnson is an inflammatory breast cancer (IBC) survivor diagnosed in 1998. She has written about cancer for HealthCentral since 2007. She serves on the Board of Directors for the Inflammatory Breast Cancer Research Foundation, the oldest 501(3)© organization focused on research for IBC. She is a list monitor for an online support group at www.ibcsupport.org. Phyllis attends conferences such as the National Breast Cancer Coalition’s Project LEAD® Institute. She tweets at @mrsphjohnson.