Each year between November 13-19, people and organizations around the country participate in Transgender Awareness Week to help raise the visibility about transgender people and address issues members of the community face. In recognition of this important event, issue of Research Review looks at ways to increase representation of transgender patients in clinical trials.
In 2021, the Bloomberg New Economy International Cancer Coalition was formed to promote international collaboration and regulatory harmonization in clinical research around the world. Earlier this year, the Coalition published a statement urging for a paradigm shift in the way patients are cared for in clinical trials as a result of changes brought about by the pandemic. Although the pandemic disrupted many processes in cancer care and clinical trial delivery, it also taught us to be more creative with our resources, giving meaning to the phrase "where there's a will, there's a way." Use of telemedicine and remote monitoring has risen drastically during the pandemic out of necessity, allowing more patients to be seen for routine care. The Coalition emphasizes that digital technology efforts should continue to be harnessed for clinical trials to expand access and increase diverse participation in research.
The COVID-19 pandemic has led to innumerable changes in the provision of medical care, most notably in the way that patients are managed in the outpatient setting. The need to reduce in-person visits forced medical providers to embrace telemedicine and develop creative ways to monitor and treat patients virtually. Although the shift toward virtual medicine has not been without challenges, it has triggered many positive developments, particularly in the field of clinical research. Despite the strong recommendations for clinical trials in oncologic treatment guidelines, only 2% to 8% of all cancer patients participate in oncology trials. These low rates of participation can be attributed to a variety of barriers from patient recruitment to data collection. Telemedicine and digital tools can help overcome some of these barriers to expand access to trials and minimize disparities in research.
Although African Americans comprise about 12.5% of the U.S. population, they represent only 5% of patients enrolled in clinical trials. Likewise, Hispanic/Latinx individuals account for approximately 18.5% of the U.S. population but represent only 2.3% to 3.9% of cancer trial participants. A quick literature search on "diversity in cancer clinical trials" reveal that these statistics highlight only a few examples of the disparities that exist in cancer research. Aside from race and ethnicity, disparities in clinical trials are also found among patients of different socioeconomic classes, education levels, genders, and more. Today, a significant focus of clinical trial development revolves around strategies to enhance diversity and ensure health equity.
Just ASK™ is a training program developed by ACCC-ASCO to educate cancer research teams on diversity, equity, and implicit biases in clinical research. This 60-minute course features didactic slides, interactive case studies, and interview segments to demonstrate how implicit biases interplay with health disparities and to explore strategies for addressing barriers to trial participation among under-represented populations. The training program commences with a review of the key concepts, using visuals and examples to illustrate definitions. For instance, in discussing equality vs. equity, the segment shows a group of individuals with differing heights, including a wheelchair-bound person, who are trying to reach for apples on a tree; equality in this context would mean giving everyone the same stepping stool to help them reach higher, whereas equity would be giving each individual the customized boost they need to ensure that all hands reach the same height on the tree. Visual learners will appreciate the use of illustrations to portray these key concepts.
CompassHER2-pCR is a trial assessing if HER2-positive Stage II-IIIa breast cancer patients can be safely treated with less chemotherapy in the adjuvant setting. Patients enrolled in this study receive a taxane (an established treatment for breast cancer) and two anti-HER2 antibodies for 12 weeks before surgery. At surgery, if patients are found to have pathologic complete response, then they would proceed with adjuvant treatment consisting of only trastuzumab and pertuzumab for one year (along with radiation and anti-estrogens as needed). Patients who have residual disease would undergo standard of care treatment with ado-trastuzumab emtansine.