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Clinical Trials Matter.

The Importance and Challenges of Clinical Trial Participation, by Heather Kehn, RN, MPH

Importance of Clinical Trials

Clinical trials are the key to making progress against cancer.  As a result of past clinical trials, people today are living longer lives from newly discovered cancer treatments that are the results of past clinical trials. Clinical trials also help find new ways to prevent cancer and improve the quality of life for people during and after treatment. When patients and their families take part in a trial, they add to the knowledge about cancer and help improve cancer care for future patients.1

The National Comprehensive Cancer Network (NCCN) guidelines state the best management for any patient with cancer is in a clinical trial.  The NCCN goes on to explain that many cancer tests and treatments widely used today, exist because of clinical trials. However, clinical trials can only be done if people have access to the research studies and are willing to join as a particpant.2

Challenges of Clinical Trials

Misconceptions can be a common challenge when it comes to enrolling patients onto a clinical trial.  A common misconception is that all clinical trials involve a placebo.  Actually, placebos are almost never used alone in cancer treatment trials. In some cases, a study may compare standard treatment plus a new treatment, to standard treatment plus a placebo.  Patients will be told if the study uses a placebo during the informed consent process.3

Also, patients may think that there are only cancer treatment clinical trials.  When really, there are many clinical trials looking at how to help patients control or prevent the symptoms of their cancer or the side effects of cancer treatment.4

Institutional barriers also exist.  For instance, 55% of patients seeking cancer care will not have a clinical trial available for their condition at the location where they are receiving care.  Another 17% will not meet the study’s eligibility requirements, and many eligible patients will not be asked by their provider to enroll.5

Taking Action, Together

There is a one-stop-shop to help patients, their family and the community understand clinical trial options and the process of enrolling onto a clinical trial.  The National Cancer Institute (NCI) developed AccrualNet™ to provide a growing, searchable database of hundreds of journal articles with easy-to-read summaries, helpful tools, sample materials, and training resources that can also be used by clinic and research staff.

A Breath of Hope is proud of its strategic partnerships in the lung cancer field and would like to thank Heath Kehn for this contribution to our Clinical Trial Blog Series.

Heather Kehn is a Program Manager with Metro-Minnesota Community Oncology Research Consortium (MMCORC).  To learn more, visit

Sources: 1. Clinical Trials Information. National Cancer Institute.  Accessed April 20, 2019 at
  1. National Comprehensive Cancer Network (NCCN). Accessed on April 11, 2019 at 3. Taking Part in Cancer Treatment Research Studies. National Cancer Institute. 2011. 4. Looking for Answers Through Cancer Research Know Your Options. Metro-Minnesota Community Oncology Research Consortium (MMCORC). 2015. 5. Overcoming Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer. Cancer Action Network, American Cancer Society. 2018.
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I’m You.

Clinical Trials Blog, Post 6, Katherine Bensen.

It wasn’t the news I was hoping for this week. My phase 1 clinical trial (first in human, open label, dose escalation study of a new treatment – a human bispecific EGFR and cMet antibody in subjects with advanced non-small cell lung cancer) did not work for me. On April 16, I had a CT scan after starting the trial six weeks ago. My stage 4 lung cancer has increased; therefore, I will no longer be participating in the clinical trial. My doctor made it clear that my participation in the trial is more than helping humanity – it is about helping me, too.

There are two reasons why my oncologist would remove a patient from a clinical trial:

  1. The patient has a reaction to the treatment; or
  2. It is not helping reduce the cancer.

Currently, because of other people participating in clinical trials, I am fortunate to have another targeted therapy treatment to try – a combination of two drugs called Crizotinib and Tagrisso. This will be my eighth line of treatment since being diagnosed with lung cancer on December 31, 2014.

Research matters.  Clinical trials matter.

My oncologist and I will continue to look for another clinical trial. I remain hopeful for more time to allow research and new drugs to find a cure for lung cancer.

Thank you for reading my blog and being with me through this experience. I am so grateful for all the brave people who came before me and gave so much by participating in clinical trials.

Anyone with lungs can get lung cancer. I am you!

#Katiewins Living with Stage IV Non-Small Cell Lung Cancer EGFR Exon 19, Erbb2, T790M & MET ~ Diagnosed December 31, 2014.

Wish mom was here (a video, Katherine’s daughter)

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Clinical Trials

Learning about Clinical Trials, by Naomi Fujioka, MD, Masonic Cancer Center, U of MN Dept. of Medicine

Clinical trials are a fundamental part of cancer care, leading to more knowledge about the cancers themselves, treatments, and/or side effects. They are often a culmination of decades of work in the lab and in animals, before being introduced to patients. For trials involving treatment, the treatment is “experimental” which means they are not approved by the FDA and not standard of care. Clinical trials come in different flavors, generally referred to as “phases.” The National Cancer Institute has a wonderful primer on clinical trials, accessible at Trials can run the spectrum from testing the safety of a drug that’s never been used in people (Phase 1), to testing an experimental treatment against a standard of care treatment (generally Phase 3) to see which one is better. Trials can potentially be an appropriate option at any stage of cancer treatment.
Patients: It’s really important for the doc to explain the purpose of the trial to you, the pros and cons, what’s known about the treatment, what is being asked of you, the potential risks, alternatives, and other pieces of information such as who will pay for the costs of the treatment and other care required during the study. These things are also written in a “consent form.” However, it’s important to be aware that a consent form doesn’t replace the doc explaining things well. It represents the way we document something called the “informed consent process.” It’s important for you to ask whatever questions you might have about a trial at any time. It’s also really important to understand that no one can force you to participate in a clinical trial, and you have the option of dropping out of a clinical trial for any reason at any time, without affecting your care or relationship with your providers. It’s voluntary. These principles and many others are strictly enforced by many parties, including the government, FDA, and institutional review boards at every institution, whose duty is to protect people participating in research.
Your doc should advocate for you and be thinking of clinical trials throughout the course of cancer treatment. Navigating and identifying clinical trials is a daunting task, but one place to start looking is All clinical trials in the United States are required to be on this website, which is run by the National Institutes of Health. When I’m looking for a clinical trial, I usually start by entering in the condition – for example “lung cancer” and limiting the search to the U.S. I also like the map view, which allows me to see what trials are available in Minnesota or any other individual state. Sometimes it’s best to type in other information – for example “EGFR” or “ALK” or “lung adenocarcinoma.” Your doc is the best person to help you search efficiently. This will save you the time of parsing through the huge amount of information on It’s also most useful to look for “active” trials, which are trials that are actually looking for patients. However, trials go through phases. It might say “active” on, but be temporarily on hold while some data analysis is going on, or some side effects are being reviewed, etc. So your doc, or the doc running the trial at your clinic, will have the information about whether the trial is actually looking for patients or not, and if not, when it might start again if it hasn’t been completed yet. Sometimes I’ll contact a doc running a trial, called an “investigator” to get more information, or sometimes I’ll contact docs around the country to see what trials he/she might have. Each clinical trial usually lists a primary contact.
Clinical trials have a lot of eligibility criteria such as who can or cannot be in the trial. A summary of the criteria is on Your doc can help determine if you’re eligible in the beginning, but final eligibility is determined once you enroll in a trial.
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I’m You.

Clinical Trial Blog, Post 5, Katherine Bensen.

So, this just happened. I woke up Saturday morning with a rash of pimple-like sores so dense and inflamed that my entire face looked like it had swollen to about three times its normal surface area. I didn’t even recognize myself in the mirror! To make matters worse, it hurt and it itched. And the more I itched, the more it hurt. The more it hurt, the more I itched. So, I spent the weekend trying to relieve my new side effect from this clinical trial by covering my face with lotions and suave – an attempt to relieve the itching, swelling and pain.

My best friend kept telling me to stop “trying to tough it out” and “please contact your doctor.” I am so glad I finally listened to her. My doctor prescribed Prednisone immediately and within a couple of hours I was feeling better. My face isn’t quite back to normal yet, and it is completely exfoliating, like a snake. Unfortunately, this is something I have experienced before from previous cancer treatment drugs. And, it really makes my skin look aged – I look about 10 years older right now. But I will take the aged appearance ANY DAY, as long as I can stay alive. I’m even happy to share these before and after pictures of one of the many possible side effects from cancer treatments because today, I am alive because of the new treatments discovered through research and clinical trials.

My experiences and the side effects from this clinical trial are being shared with the pharmaceutical company that produced the drug as well. This allows others to learn from my experience and work to improve the treatment.

I’m hoping this side effect (or something worse) doesn’t happen again after my next treatment, but if it does, I will call my doctor sooner! A side note: as much as I don’t like taking steroids, they did make me feel good enough to go to the gym today with my son, Henry. Being with family and being able to go to the gym makes most anyone feel better!

Research matters. Clinical trials matter. I’m you.

#Katiewins Living with Stage IV Non-Small Cell Lung Cancer EGFR Exon 19, Erbb2, T790M & MET ~ Diagnosed December 31, 2014.

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