Features Associated with Successful Recruitment of Diverse Patients onto Cancer Clinical Trials: Report from the American College of Surgeons Oncology Group

Abstract

Background The clinical trials mechanism of standardized treatment and follow-up for cancer patients with similar stages and patterns of disease is the most powerful approach available for evaluating the efficacy of novel therapies, and clinical trial participation should protect against delivery of care variations associated with racial/ethnic identity and/or socioeconomic status. Unfortunately, disparities in clinical trial accrual persist, with African Americans (AA) and Hispanic/Latino Americans (HA) underrepresented in most studies. Study Design We evaluated the accrual patterns for ten clinical trials conducted by the American College of Surgeons Oncology Group (ACOSOG) 1999–2009, and analyzed results by race/ethnicity as well as study design. Results Eight of ten protocols were successful in recruiting AA and/or HA participants; three of four randomized trials were successful. Features that were present among all of the successfully-recruiting protocols were: (i) studies designed to recruit patients with regional or advanced-stage disease (2/2 protocols); and (ii) studies that involved some investigational systemic therapy (3/3 protocols). Discussion AA and HA cancer patients can be successfully accrued onto randomized clinical trials, but study design affects recruitment patterns. Increased socioeconomic disadvantages observed within minority-ethnicity communities results in barriers to screening and more advanced cancer stage distribution. Improving cancer early detection is critical in the effort to eliminate outcome disparities but existing differences in disease burden results in diminished eligibility for early-stage cancer clinical trials among minority-ethnicity patients.

Barriers to Clinical Trial Enrollment in Racial and Ethnic Minority Patients with Cancer

“…Many of these barriers have a disproportionate effect on minority enrollment because members of minority populations are more likely to receive care at under-resourced hospital systems where few clinical trials are available, to be underinsured, and to present with comorbidities that make them ineligible for trials that may be available. 28–30 …”

Twenty years post‐NIH Revitalization Act: Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual

“…Considered as the gold standard, 5 clinical trials offer scientifically rigorous approaches to develop and evaluate better and/or safer anti-neoplastic interventions, with the ultimate goal of establishing new practice standards. 6 As a result, the major advances in cancer treatment have emerged from clinical trials. 7 Participating in most clinical trials offers benefits to patients such as the provision of the state-of-the-art care compared to a potentially more effective intervention and improved survival.…”

Feasibility of Trials in Ovarian Cancer by Line of Therapy and Platinum Sensitivity

“…Combined with strategies to overcome social, economic, and communication barriers to trial recruitment will improve our ability to realize the potential of novel drugs in development. 14,15 …”

“…14, 15 The importance of a trial infrastructure and active trial portfolio management has been strikingly demonstrated in the United Kingdom, through the establishment of the NCRN in 2001. 9 This has led to a 3-fold increase in trial recruitment from less than 3.5% to the current 12% of incident cases, and an increase from 39% to 74% in the number of trials that have met their recruitment targets on schedule.…”