Patient-Driven Solutions May Lead to Greater Metastatic Breast Cancer Clinical Trial Participation

Findings from a patient-led study suggest that adopting a collaborative, systematic, solutions-based approach may enable more patients with metastatic breast cancer (MBC) to participate in clinical trials. The rate of participation in clinical trials for breast cancer is dismally low, which is slowing drug development and adding to overall costs. However, more patients living with MBC reportedly would be willing to participate in clinical trials if some changes were made, according to data from a poster presentation at the 2019 San Antonio Breast Cancer Symposium in Texas.

The study was conducted using a mixed-methods design that included in-depth interviews and online surveys. Sixty-one participants were invited to be interviewed using purposeful stratified sampling. This included patient race, age, and geographic location. The study also included community and academic center oncologists and administrators, researchers, research staff, and payers. Additionally, the researchers surveyed 496 women living with MBC (mean age, 53 years). The mean number of years that patients were living with MBC was 4.6 and the respondents generally reported positive attitudes toward trial participation.

This investigation was novel because the survey questions included more than demographics, trial experience, and perception of benefits and disadvantages of clinical trial participation. It also asked about barriers to trial participation, and asked for ideas for solutions to the barriers. The researchers incorporated a short social media poll about trial participation.

The study found that trials may need to open up eligibility criteria in order to increase diversity and the number of individuals willing to participate. The researchers found that participants with MBC rated the opportunity to receive innovative treatments as extremely important. Helping others with MBC and contributing to research were also rated as being extremely important. The potential disadvantages cited by the participants were fear of side effects and concern about the possibility that trial drugs may not be effective. Financial toxicity was also a concern.

“A dominant theme from rural and community-based oncologists was the need to address geographic, logistical and financial barriers using more ‘portable’ multi-institution trials, providing transportation and adequate reimbursement for patients’ expenses,” the author wrote. “Clinicians in academic [settings] described exclusion criteria as a significant barrier for heavily pretreated MBC patients.”

Reference

Kaplan M. Hear our voice: Patient-driven solutions to increase participation in clinical trials. Poster presentation at: 2019 San Antonio Breast Cancer Symposium; December 10-14, 2019; San Antonio, TX. Abstract P1-16-03.