Reimagining diversity in multiple myeloma clinical trials

Abstract

Multiple myeloma is primarily a disease of the elderly with a median age at diagnosis of around 66-70 years. It is now also established that it disproportionately impacts ethnic/racial (hereafter referred to as ethnic) minority groups in both incidence and outcome. [1][2][3][4] For instance, monoclonal gammopathy of unknown significance and multiple myeloma tend to occur twice as frequently in African Americans compared to European Americans. 5 Improvements in multiple myeloma survival with the advent of novel therapies are also less apparent in ethnic minority groups, especially in the older patient population. 3,5,6 Such ethnic differences in the burden of multiple myeloma cannot be solely attributed to socioeconomic factors and variations in access to care, but may likely also be associated with underlying genetic and biologic differences. 14 To further complicate the picture, elderly patients and ethnic minority groups continue to be underrepresented in cancer clinical trials in general, and multiple myeloma studies in specific. [7][8][9][10][11][12][13][14] In a recent review of 112,293 patients recruited in 230 oncology trials that led to FDA approvals in the last decade, only 3.1% of patients were blacks and 6.1% were Hispanics (compared to 76.3% whites). This represented no more than 22% and 44% of their expected representation if compared to their proportion of US cancer incidence, respectively. 11 The enrollment-incidence disparity for multiple myeloma was second highest among all cancers in blacks and Hispanics, with an enrollment to incidence ratio (i.e., number of those enrolled over those "expected" to be enrolled based on disease incidence across ethnic groups) of 21% for blacks and 4% for Hispanics. 11 The enrollment-mortality disparity was equally high. 11 Another pooled analysis of 2896 patients from nineThis is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Patients at the Heart of the Scientific Dialogue: An Industry Perspective

“…At Pfizer, we have joined other industry partners in the Center for Information and Study on Clinical Research Participation (CISCRP, www.ciscrp.com), with a core mission to provide accessible, relevant, useful, highquality educational resources, programs, and services that increase patient awareness and understanding of the clinical research process [10][11][12]. Pfizer Oncology's Patient Centricity Ecosystem (POPCE) was also launched in 2019, with 40?…”

“…advocacy organizations having regular discussions with Pfizer leadership. This program generated over 40 ideas for Pfizer to consider, and these were prioritized to focus on three core areas: health literacy, health equity, and increasing patient engagement in clinical trials [10][11][12]. Our teams have regular touch points with patient advocates to assess unmet need, co-create with them, gain feedback on newly deployed resources, and brainstorm new educational opportunities for the future.…”

“…Seeking input from patient representatives and caregivers earlier during study design can also help ensure appropriate and feasible trial eligibility and assessment criteria are in place. This would not only maximize participation in research but also ensures diversity and representation of ethnic minority groups and special populations such as the elderly [10][11][12]. Patients could help build directly relevant clinical trial education materials for their own peers and be part of implementation by acting as community educators.…”

“…Including testimonials of patients who have been in clinical trials would resonate with future participants from the same age, gender, or ethnic group who can relate and identify with such experiences [44]. We have taken things a step further at Pfizer, by creating the Blue Button Program that allows patients in our clinical trials to have access to their clinical trial data, thus helping them feel more involved in the research they are being part of [10][11][12].…”

Diversity in Oncology Clinical Trials: Current Landscape for Industry-Sponsored Clinical Trials in Asia

“…In contrast, only 11% were Asian, 7% were Black/African American, those categorised as ‘other’ made up 4%, and American Indian or Alaska Native participants accounted for 1% [ 4 ]. Despite the fact that these demographics do not accurately mirror the global population, it has been widely acknowledged and recognised that the participants enrolled in clinical studies should closely reflect the real-world population(s) affected by the medical condition and require investigational treatment [ 5 – 7 ]. This ensures that the investigational product is being tested in a context that is as realistic as possible.…”