Posted on December 22, 2022

By Zoë Christopher, MA (she/her), Program Officer & Resource Liaison

Bringing Trials to All Patients

Does a Black or Latinx patient respond to a specific drug differently than a white patient? Is a drug that’s effective for a premenopausal woman with breast cancer also effective for treating a 45-year-old male with breast cancer? 

Clinical trials have provided some scientific advances in the treatment of breast cancer and trials are often the best option for getting treatment. So why is it that only 5% of cancer patients enroll in clinical trials? And why are participants overwhelmingly white? This lack of diversity in participation in trials is well-known, but now that we have the facts, we need solutions. Scientific advances must benefit the general population.  

Thelma Perry Brown, BSc, is a patient and research advocate and a member of the University of Alabama Breast Cancer Working Group and the Translational Breast Cancer Research Consortium. She has worked closely with basic science, clinical, and translational researchers, and she has ongoing direct contact with patients, so she is acutely aware of the barriers to participation that are faced by many communities. Most of these barriers are common to all groups left out of the studies, and include, but aren’t limited to, inadequate access to and knowledge of trials, physician bias, narrow eligibility criteria to enter the trial, and general mistrust of the medical industry. 

Lack of knowledge about trials is pervasive: if the physician doesn’t know about or suggest it, patients are unlikely to find information on their own. As the Resource Liaison for BCAction, I’ve been contacted several times over the years by organizations that are working on the development of digital applications that would allow patients to find trials and assess their eligibility before presenting their findings for discussion with their doctors. Eventually this may help.  

If we’re going to improve patient participation, the eligibility for clinical trials needs to be expanded. The elderly are often overlooked but must not be excluded for being “too old” or for being prescribed too many medications. For our senior population that is constantly increasing, we need effective treatment for them; we need to know how treatment will interact with their medications. And we need their caregivers, who have tremendous influence on the patient’s decisions, to be able to advocate for them.  

Comorbidities are often higher in the Black community, making patients ineligible for trials, but we still need to know how to develop effective treatments that takes these complications into consideration. And for Asian and Hispanic/Latinx patients, the language barrier is yet another reason to avoid participation in clinical trials. We need written and online materials translated and we need competent interpreters and navigators.  

In short, it will take a community + industry effort to get clinical trials to under-represented portions of the population. 

  • Access needs to be improved. Many patients are faced with personal challenges that may include things like child care and transportation issues (particularly in rural areas). Having enough time and money is not the lived experience of all patients. 
  • Patients and their doctors need to be made aware of trials, and have easy access to that information. 
  • Both clinicians and investigators should be required to have anti-bias training because bias is often subtle or simply denied by clinicians yet obvious in their recommendations, or lack of recommendations.  
  • Diverse representation is needed at the trial design stage because these investigators will have access to their communities and will be better able to recruit. 
  • Patients need to be involved at the trial design stage in order to develop what Brown calls “human centric trials.” What matters to the patient is as important as what matters to the investigator. 

And it will take an integrated effort and commitment of all stakeholders including: 

  • Service providers that are culturally competent 
  • Patient advocacy groups to carry the collective patient voice 
  • Technology companies to develop useful applications that will improve access and compliance 
  • Nonprofit organizations to advocate for patients, educate the public, and reach out and into communities 
  • Clinical trial sponsors who will help fund an expanded model for patient participation 
  • Pharmaceutical companies willing to invest in research that will benefit smaller groups of patients, including those with predicted shorter lifespans 
  • Contract Research Organizations that monitor compliance of trials and manage data throughout  
  • Regulators that are sensitive to the needs of underserved communities 

Over the course of the SABCS conference, I listened to several presentations that included models that were being used and tested in clinical settings, but also some that were hypothetical and more about visions for an ideal world. BCAction has been engaged in a research project for the last year that includes community nonprofits serving Black, Hispanic/Latinx, Mixteco, Vietnamese, Chinese, and Pacific Islanders. For nonprofits, capacity is often limited and we do not want to create additional stress. So I ask myself: How do we integrate a new scientific model of clinical trial participation with under-resourced community organizations and patients? When do we start funding, recruiting and training personnel to do effective outreach to stakeholders? How do we serve those who’ve been left out of the research? How do make inclusive trials a reality? And who will create a strategic plan to make this happen?