NBCC Statement on Clinical Trails Diversity

The NBCC Board of Directors approved the below Statement on Clinical Trials Diversity. NBCC will use these principles to:

  • Analyze legislative proposals regarding clinical trials diversity
  • Educate our members and the public on the issues
  • Apply to NBCC’s work through our Clinical Trials Initiative

February 2023


The National Breast Cancer Coalition (NBCC) and its advocates work to ensure that clinical trials of interventions that may save lives, prevent breast cancer and/or change the way people are treated, move forward quickly and with input from advocates. NBCC has a long history of collaboration and leadership in clinical trials that have had a significant impact on breast cancer.

We must make certain that clinical trials are designed with scientific integrity and such that the results are generalizable to a diverse population. Trial design must not contribute to persistent racial and other disparities in access to care and cancer outcomes.

Trained advocates must be in leadership roles in clinical trial conception, design, and implementation, in order to make a real difference and maintain a focus on what is best for individuals with and at risk of breast cancer. NBCC’s Project LEAD-trained advocates have participated in all levels of clinical trials through its Clinical Trials Initiative.

The Initiative was developed to improve critical breast cancer clinical trials and increase access to meaningful, high quality clinical trials for all breast cancer patients. A clinical trial is one of the final stages of a long and complex research process that studies new interventions. It is a study involving individuals, carefully designed to answer a scientific question and find out whether a promising approach to prevention, diagnosis, or treatment is safe and effective. As part of its Clinical Trials Initiative, NBCC works with research organizations at all levels of trial development and implementation, from early development of the trial protocol, as members of the Steering Committees and Data Safety Monitoring Boards, to input on educational materials and consent forms, and in conducting outreach activities to educate the public about specific trials.

NBCC supports the following set of principles to ensure diversity and generalizability of trial results to individuals representative of the disease being studied.

Clinical Trials must:

Be appropriatelyinclusiveof racial and ethnic minority groups, as well as other populations experiencing health disparities, including sexual and gender minorities, socioeconomically disadvantaged populations, and individuals with disabilities.

Lower barriers to participation, including geographic, financial, insurance-related, language, education/awareness, mistrust, access to technology, or data collection burden without compromising scientific integrity.

Incorporate patients, patient advocacy organizations, and community leaders and groups at all levels, to bring a patient’s perspective to the table and maintain a focus on outcomes, and clinical trial design that benefits people, and to increase interest and participation in clinical trials.

Gather uniform baseline data about social determinants of health (e.g., socioeconomic, cultural, as well as place-based factors such as access to health care, transportation, education systems, safe neighborhoods, availability of healthy foods, etc.) from clinical trial participants, as increasing evidence suggests that these are linked to cancer outcomes and a contributor to disparities.

Ensure that all trial results are communicated with trial participants and the research community in a timely manner, including the reporting of demographic characteristics comprising the study population.