Meeting Trial Participants Where They Are: Decentralized Clinical Trials as a Patient-Centered Paradigm for Enhancing Accrual and Diversity in Surgical and Multidisciplinary Trials in Oncology

Abstract

Author affiliations and support information (if applicable) appear at the end of this article.

From Race to Racism and Disparities to Equity

“…98,99 Other innovations in the structure of the clinical trials system will be necessary to truly foster diversity and representativeness, including decentralization of research to locations near patients of color. 100 In a recent analysis of accrual patterns by race for a large breast cancer cooperative group trial that oversamples Black women, we found that the most important site-level predictor of high accrual of Black patients was the proportion of Black residents in the zip code where the trial site was located. 101 Other key strategies, as outlined in a recent policy statement from the American Society of Clinical Oncology and Association of Community Cancer Centers, include education of the research workforce on equity, diversity, and inclusion issues and diversifying the workforce itself to reflect the communities in which cancer research is performed.…”

“…Two recent studies of cooperative group breast trials suggested that elimination of willing participants at the eligibility stage was not a large reason for nonparticipation, although these studies did not focus specifically on Black patients 98,99 . Other innovations in the structure of the clinical trials system will be necessary to truly foster diversity and representativeness, including decentralization of research to locations near patients of color 100 . In a recent analysis of accrual patterns by race for a large breast cancer cooperative group trial that oversamples Black women, we found that the most important site-level predictor of high accrual of Black patients was the proportion of Black residents in the zip code where the trial site was located 101 .…”

Study protocol: A comparison of mobile and clinic‐based spirometry for capturing the treatment effect in moderate asthma

“…Continuous or daily measurements also allow for a greater understanding of day‐to‐day symptom variability not captured in a pre/post design, which is particularly important for outcomes with known diurnal variability, such as lung function in asthma 27,28 . The collection of data in the home environment may represent a more accurate reflection of the patients' lived experiences than on‐site measurements, 29 aligns with a patient‐centric approach to trial design and implementation, 30 and is associated with high patient satisfaction 31 . Finally, eliminating or reducing the need for in‐clinic visits removes many barriers to trial entry, potentially increasing the rate of recruitment while improving accessibility, diversity, equity, and inclusion 32 .…”

Patient-Reported Adverse Events During Neoadjuvant Therapy in a Phase 2 Borderline Resectable Pancreatic Cancer Clinical Trial (Alliance A021501)

“…Alternative and creative mechanisms to collect patient-reported data should be explored, particularly methods that are accessible to patients from a variety of cultural backgrounds and levels of health literacy. 17 These considerations are critical to ensure the inclusivity of diverse patient populations, minimize undue administrative burden to patients, optimize compliance with data collection, and yield clinically meaningful results.…”

“…In addition, trial design should identify opportunities to improve data collection at multiple time points, including during the perioperative and survivorship period, to allow for improved longitudinal analysis of the cumulative impact of treatment. Alternative and creative mechanisms to collect patient-reported data should be explored, particularly methods that are accessible to patients from a variety of cultural backgrounds and levels of health literacy 17 . These considerations are critical to ensure the inclusivity of diverse patient populations, minimize undue administrative burden to patients, optimize compliance with data collection, and yield clinically meaningful results.…”