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Call to Action Online – August 5, 2020

August 5, 2020

NBCC Remembers Congressman John Lewis – A Message From Fran Visco

Not long after we launched our Deadline2020 Campaign, several NBCC advocates and I met with John Lewis to ask him to help. I think it took about two minutes for him to “get it” and sign on. I actually met the Congressman on a visit to his office with our Georgia advocates several years before that. I remember being stunned; here was one of my heroes, an extraordinary, courageous leader, and a decent man of integrity. It was all I could do to keep the tears of joy from streaming. Congressman Lewis took us on a tour of his office, pointing to the photos of Martin Luther King Jr. and other civil rights leaders at various events I had only ever read about, and telling stories. You can probably imagine how humbled and thrilled we were.

He came to a meeting we held in Atlanta to mobilize the community around our Deadline 2020 Campaign and addressed the advocates attending. He signed onto every one of NBCC’s priorities, every time. He allowed us to honor him on Capitol Hill in 2016, where he told us to “get into good trouble, and together we will end breast cancer.” He told me that day he wanted to meet the “young people.” And they all lined up to shake his hand and talk to him. John R. Lewis was the epitome of a dedicated public servant and an unparalleled role model for all of us. We issued a statement on his passing, but it is impossible to describe how great this loss is and what he meant to all of us who care about social justice. We miss him and will continue to honor his memory.

Clinical Research and Ethics: What Should We Know? 

On July 29, 2020, NBCC hosted a LEAD cast webinar with Dr. Jonathan Kimmelman, James McGill professor in the Biomedical Ethics Unit/Social Studies of Medicine at McGill University on the ethics of clinical research.

Dr. Kimmelman started by discussing the Belmont Report,1 which lays out three core principles for human research:

  • Respect for persons, which is operationalized by always getting informed consent from patients before enrolling them.
  • Beneficence—ensuring that risk experienced by participants is outweighed by the benefits to society and the benefits to the volunteer, if any, and operationalized by making sure that a third party such as an IRB (institutional review board) is refereeing those judgments.
  • Justice – ensuring that the research generates information that is going to be applicable, not just to an advantaged population (e.g., those who would be able to afford a new treatment that derives from the research), but also to a disadvantaged population (e.g. those who might not be able to afford the new treatment.)

The principles are sequential, in that patients will not be consented unless the study is fair and has a favorable risk-benefit balance. And they are not exchangeable. All principles must be met.

Dr. Kimmelman explained the ethical requirement of clinical equipoise, that a randomized controlled trial (RCT) is designed with the assumption that a “better” intervention for either the control or experimental arm does not exist. Clinicians should never violate their duty of care when conducting clinical research and must be confident that randomization is not going to put patients into a treatment arm that is known by the expert community to be inferior to the other arm. And, a clinical trial should be designed such that, if successful, it’s likely to actually change the belief of expert communities.

Dr. Kimmelman spoke to some of the challenges of implementing clinical equipoise. The first is in establishing when it actually exists. How do we know there isn’t a better treatment available? The ideal way to determine this is to conduct a systematic review, before the launch of a clinical trial, to see if better interventions exist.

The second is determining whether the risk-benefit balance is favorable in a clinical trial. What does that mean? There are a lot of different requirements in trials that create burdens and risks for patients, such as extra clinic visits, blood draws, biopsies, or scans. Trialists use component analysis to identify and minimize the treatment- and research-related risks of each such element (e.g., required scans, blood draws, etc.) included in a trial, and to ensure that risks imposed are justified by the social value of the knowledge to be gained.

A third operational issue is in implementing what is called “efficiency.” Trials should be addressing questions important to society, and because uncertainty in clinical research is an ethical requirement (i.e., clinical equipoise exists and we really do not know which arm is better), on the whole, new interventions should outperform standard of care only about half of the time. Much more than that would raise a question about whether the trials are correctly designed or whether clinical equipoise is actually present. This has been demonstrated in a retrospective view of more than 50 years of randomized trials.2

As research advocates, we have the responsibility to ensure that meaningful questions are being asked, that the burdens of trials are minimized, and the actual standard of care is indeed being used for the comparator/control group in all clinical trials. If you are interested in helping to advance ethical clinical research in breast cancer, we challenge you to join NBCC and get involved. Learn more about our advocate educational opportunities on our website.

  1. THE BELMONT REPORT. Office of the Secretary. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; April 18, 1979. Free Full Text
  2. Djulbegovic B, Kumar A, Glasziou P, Miladinovic B, Chalmers I. Medical research: Trial unpredictability yields predictable therapy gains. Nature. 2013;500(7463):395-396. Free Full Text

Tell us your NBCC Advocacy Story 

We are part of NBCC for a reason, and that reason is different for each of you. You may be a survivor or the family member of someone who has breast cancer or has lost their life to breast cancer. Or, another reason entirely. We need your stories. Why are you an NBCC advocate? We want to share your advocacy story with others so they, too, can become a catalyst in our fight to end breast cancer. Let others know it is not only possible to change the world, but that each one of us can help make that happen.

Tell Us Your Advocacy Story

Boost Your Donation’s Impact Through #HalfMyDAF 

We have an opportunity for your donation to have a larger impact on NBCC through the #HalfMyDAF matching-grant challenge. Right now, non-profits like NBCC are working harder than ever, with decreasing funds, and tighter budgets. At the same time, over $120 billion sits unused in Donor Advised Funds and community foundations across the country. The #HalfMyDAF challenge aims to put these charitable dollars to work now, when, and where they are needed most.

Anyone who commits to granting half their money from a Donor Advised Fund before September 30, through #HalfMyDAF gives NBCC the chance to be one of 150 non-profits to receive a matching grant of up to $25,000. The more people who nominate NBCC, the better our chances. You know that NBCC is working harder than ever to end breast cancer. Please consider designating NBCC when you #halfmydaf.com.