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Clinical Trials – Patients ARE Heard in the Process

Editor’s Note: After a long and resilient battle with primary peritoneal cancer, Roberta Aberle, 53, of Auroro, CO passed away on November 1, 2017 with her husband David Oine at her side. Even as she battled her own cancer, Roberta was a tireless advocate for patient care, hoping to improve the lives of others also fighting life-threatening illnesses. She will be greatly missed by all who knew her.


Bravo to Patient Empowerment Network for providing cancer patients the program series, Mythbusters on Clinical Trials. [NOTE: Segment #3 to be broadcast Sept 6th, 2017 – see program link to register concluding this blog].

Without access to this type of content, how else would patients like me know the value or merits of participating in a clinical trial? Especially a patient like me, who worked in an academic medical facility, recruiting patients for clinical trials for a different medical speciality before my cancer diagnosis. Even I did not have a fundamental understanding of the benefits for me and my diagnosis.

I did have a fundamental understanding of my dire cancer prognosis however. It was as grim as our worst fears. The best option of care presented in that initial oncology consultation was palliative and comfort care measures for my remaining months. I was deemed inoperable due to the extent and metastatic spread of my disease. Even front line chemotherapy was portrayed as uncertain for my rare cancer form, Primary Peritoneal Carcinomatosis (PPC). At least, no evidence-based medicine with a large population of survivors, longevity to discern average duration of progression free disease, let alone, studied in depth enough to provide statistics with any degree of confidence.

The topic of clinical trials was brought up by me, not my oncologist. His response, “Clinical trial enrollment and acceptance can be a lengthy process.” In the subtext, all I heard is that he thought I would be dead before I was enrolled.

However, what my Oncologist didn’t know was that death not an option for me. Not only had I underwent a total hysterectomy due to my history of uterine growths and familial risk factors, including the BRCA1 mutation and extensive extended family cancer; I had already lost one sister to early onset ovarian cancer.  I aso had a second sister who had ceased treatment due to unmanageable side effects from two forms of breast cancer. I knew our family could not withstand another devastating loss to cancer. My parents are elderly and the grief from having lost one daughter with another hanging in the balance if remission would come; adding myself to the mix just seemed another cruelty to hard to deliver.

Fortunately ~ something went right for me early in the process. I was fast-tracked within ten days into a clinical trial, and my treatment started within two weeks. It was a Phase 3 clinical trial of combination therapy including a platinum-based chemo https://www.drugs.com/mtm/carboplatin.html

a second anti-neoplastic chemo

https://www.drugs.com/taxol.html

and a VEG-F inhibitor

https://www.drugs.com/avastin.html

all proven to work effectively together, but with a power boost, a new to market oral agent called a PARP inhibitor.

https://www.drugs.com/drug-class/parp-inhibitors.html

The beauty and greatest appeal of this particular clinical trial, and is a constant in many trials available to cancer patients today; is it fell into a Phase 3 or higher, did NOT include a placebo arm and was comprised of all known, effective agents. The purpose of the study was to identify in what frequency and dosage all worked best, not whether they would have efficacy. I knew what was being tested, which drugs were incorporated and what outcome (dose, frequency parameters defined) was expected. I was impressed at the degree of information captured, analyzed and monitored throughout my clinical trial. Never once feeling at risk of an adverse event or my identity compromised. nor, never once did I feel I did not have the power to suspend my participation if I felt any risks.

Oversight comes from many places, including national and state foundations and organizations with the 100% directive as guided by the principles set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the Belmont Report) [https://www.hhs.gov/ohrp/]. Reviews of research are performed in accordance with the Department of Health and Human Services (HHS) regulations 45 CFR 46 (also known as the “Common Rule”) and the Food and Drug Administration (FDA) regulations 21 CFR 50 and 21 CFR 56.

https://www.fda.gov/scienceresearch/specialtopics/runningclinicaltrials/ucm155713.htm

I experienced an exceptional response on the clinical trial. My specific cancer marker fell from a pre-treatment high of nearly 3,000 (normal range value = 0 to 35) to 200 within the first six months. While I wish I could conclude this section saying I’ve since been cancer free or in remission. It was a short-lived response. I had disease progression the following year, but I never regret being on that clinical trial. In fact, still today, the PARP inhibitor component I was responsive to in my clinical trial, is still a core of my current treatment plan.

I can say with confidence, I am here as long as I have been by being receptive to clinical trials. That first trial, while ultimately not my cure, bought me time until the PARP inhibitor was approved by the Federal Drug Administration (FDA) for provisional production and release to patients failing 3 or more front-line treatments. As, unfortunately, following the clinical trial, after invasive surgery and debulking, intraperitoneal cancer, I had yet another round of disease progression. I also say with confidence, that first clinical trial was just my first bridge to conventional treatment and surgery.

I’ve played an informed game of leapfrog from clinical trial to conventional treatment to surgery, back to clinical trial and back into conventional treatment. Each clinical trial yielded powerful information about my responsiveness to alternative and combination therapies that proved integral to my next treatment plan.

The result being that I am here today to tell my tale. Six months is now 5 years and 6 months down the path of my cancer experience. A clinical trial was not – has not yet – provided my cure. But having these bridges to new options that were not available to me six months earlier, is not a back track record in my mind.

It still astounds me however, of the estimated 20 – 40% cancer patients who meet criteria for clinical trials, only 3-4% enroll.

https://www.standuptocancer.org/innovations_in_science/view/the_ins_and_outs_of_clinical_trials

I am far from considered an expert on clinical trials, have passed certification and credentialing for enrolling patients and performed data collection in my past role, but my most powerful opinion is based upon personal experience. Being afraid of being used as a guinea pig is an era far receded into the past. Today’s clinical trials are more innovative and more effective than ever. If a clinical trial buys you even 1 week or 1 month of quality time, I say it’s worth it. Even if I were a guinea pig in the process, my vote is that it would have been worthwhile. I would just have chosen to be the squeakiest among the bunch!

See us live on this topic!!

https://www.patientpower.info/event/myth-busters3

Improving Clinical Trial Design

Interview With Dr. Michael Thompson (@MTMDPhD), Medical Director, Early Phase Cancer Research Program, University of Wisconsin

Carol Preston’s interview with Dr. Michael Thompson discusses issues related to clinical trial design. The obstacles to good patient-centric clinical trial design are numerous. The informed consent is a text-only legal-type document containing difficult to understand verbiage. Instead, it should be more patient-friendly, with images, graphics and easy-to-understand instructions.

Patients are becoming more empowered and more aware of the issues and are speaking out and willing to participate to make clinical trial design more patient-friendly and effective. More patients are aware of trials and want to educate and inform others. Clinical trial design and informed consent need to be updated and made more efficient so that more patients will be able to easily consider clinical trial enrollment.

Check out the full conversation and the rest of Dr. Thompson’s ideas in the video below:

Improving Clinical Trial Design from Patient Empowerment Network on Vimeo.

Why So Few Adults in Clinical Trials?

Interview With Dr. Michael Thompson (@MTMDPhD), Medical Director, Early Phase Cancer Research Program, University of Wisconsin

In Carol Preston’s interview with Dr. Michael Thompson, he states that about 60% of children participate in clinical trials, but only 3-5% of adults do. So, the question becomes, why are there so few adults participating in clinical trials? What are the adults afraid of? Dr. Thompson goes through some of the reasons why adults do not participate as much in clinical trials as much as children:

  • Patients do not qualify for the available trial
  • Patients believe trials require more testing, resulting in more travel and higher costs
  • Patients think trials may require too much effort on their part
  • Many patients distrust clinical trials
  • Patients don’t believe in the drugs
  • Many patients are not even aware of available clinical trials
  • Patients are afraid of receiving a placebo
  • Patients are afraid of having adverse side effects from the medication

Check out the full video below as Dr. Thompson further discusses this topic and how trial enrollment statistics could change through patient education and engagement. If cancer patients are informed about what clinical trials could offer them, or if they are able to ask questions, more adult patients may be more willing to participant in these trials.

Why are Patients Afraid of Enrolling in Clinical Trials- from Patient Empowerment Network on Vimeo.

How Do I Enroll in a Clinical Trial?

Oftentimes when we hear the word “cancer,” we hear nothing else. Our brains stop processing information. We think we’re going to die, that there is little or no time to weigh options and/or get our affairs in order.

Fortunately, that last part the vast majority of the time isn’t true. We DON’T have to rush into anything. We DO have time to weigh our treatment options. And for many patients, those options can include enrolling in a clinical trial.

What is a clinical trial?

According to PAF, the Patient Advocacy Foundation, clinical trials are research studies in which we patients can help doctors find ways to improve cancer care.

There are several types of trials

  • Treatment: to test a new drug or approach to surgery
  • Prevention: to test new approaches with medicine, vitamins, minerals to help lower the risk of developing certain cancers
  • Screening: Best ways to detect cancer early
  • Quality of Life: Explore ways to comfort, quality of life for patients

Why participate in a clinical trial?

Through clinical trials, doctors and researchers find better ways to prevent, diagnose and treat cancer. Patients can benefit by receiving cutting-edge care or emerging medications. Rarely are placebos, or fake medications, used in clinical trials. Patients for the most part are being given the current standard of care or the new treatment, to determine the following:

  • Phase   I: Is the new treatment safe?
  • Phase II: Does the new treatment work?
  • Phase III: Does the new treatment work better than the current one?

Is a clinical trial right for me?

There are risks and benefits. A good place to start making an assessment is with your physician. Often, we’ll hear about a clinical trial from our doctor. However, you don’t have to have your doc’s OK to enroll in a trial, and it’s key to determine which trial is right for you.

While there is no one source to learn about all cancer clinical trials, you can break it down into clinical trial lists and matching services.

Lists:

The National Cancer Institute (NCI): 1-800-4-CANCER (422-6237 NCI sponsors most government-funded trials. You can search by the type and stage of cancer, by the type of study (treatment or prevention) or by zip code.

The National Institutes of Health (NIH):   NIH database is larger than NCI but not all trials are cancer studies

CenterWatchCenterWatch provides a list both of industry-sponsored and government-funded clinical trials for cancer and other diseases.

Private companies: Pharma or biotech companies may list studies they are sponsoring, either on their websites or through a toll-free number. You can search a company with the words ‘clinical trials’ in the search. If that company is conducting trials, it will appear in your search. For example:

pfizer.com/research/clinical_trials

amgentrials.com

abbviephase1.com

You get the idea.

As for those clinical trial matching services, each one works differently. Some may charge a fee to the trial sponsor. It could impact the way studies are ranked or presented to you. We suggest you start with the free sites. Sources include:

The American Cancer Society Clinical Trials Matching Service:    1-800-303-5691  ASC works with a company called Eviti  to connect patients with trials. It’s free. It’s confidential. It’s reliable. The lists are updated daily, and it allows patients to contact health care providers running the studies. The website also explains how to determine if you are eligible for a trial, if a trial is right for you.

EmergingMed:  1-877—601-8601  Also free, confidential and reliable for cancer patients seeking a trial.

Various organizations have partnered with EmergingMed and offer widgets that link to the EmergingMed trial finder. For instance, both the sites below link the viewer to the EmergingMed clinical trial finder:

www.oncolink.org/treatment/trials.cfm

www.lungcanceralliance.org

There is a wealth of information here. But you don’t have to become a Medical Doctor to digest and evaluate it. Start with your physician. If he or she doesn’t have enough information, choose a website or two on this list to navigate for information about trials. That’s what I’ll be doing should the day come that I need additional treatment. We are our best advocates about what’s right for us and when.

(We want to help you if you are considering a clinical trial. Please look at our FAQ and Clinical Trial Toolkit pages and browse our Patients Helping Patients blog for articles on clinical trials)

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