Background: African Americans are underrepresented in randomized clinical trials (RCTs). Underrepresentation of this patient group may lead to an inadequate analysis of therapy risks and benefits, and study findings may not be generalizable to a diverse patient population. Moreover, low representation of African Americans in existing clinical trials may discourage future trials focused on this population, as such trials are perceived to be infeasible. Barriers to participation in clinical trials have been extensively studied. Frequently identified factors include: systemic barriers (availability of clinical trials, eligibility barriers, lack of resources), geography (location of the research institution and access to transportation), and individual-level barriers such as low education, poverty, and poor access to healthcare. Willingness to participate has been cited as a major barrier, related to distrust in the US healthcare systemand to cultural and religious beliefs. Yet a dearth of empirical evidence bolsters the assertion that willingness to participate in clinical trials among African Americans is accountable for underrepresentation. We performed a retrospective review of major RCTs focused on sickle cell disease (SCD) in order to measure willingness of African Americans to participate in clinical research. Methods: We systematically identified landmark peer-reviewed RCTs focused on SCD. We analyzed the results of these trials reported in the medical literature and calculated participation and completion rates for each trial. For each study, we identified the number of subjects screened for participation, the number who agreed to participate, and the number who declined. We calculated ratios for study acceptance and study completion. We identified the number of publications which clearly reported data from which acceptance to participate could be directly calculated, the number from which participation could be inferred, or from which reported data were insufficient. Results: We identified 13 RCTs published between 1986 and 2018, representing the major clinically impactful studies in children and adults with SCD. Six of the 13 studies reported sufficient data to infer or calculate participation rates. It is notable that more than half (54%; n=7) of the studies provided insufficient data to calculate study acceptance rates. Our analysis encompassing 2407 patients included in six studies indicates that 82% of subjects with SCD demonstrated willingness to participate in an RCT (range 32-94%), and 95% of clinical trial subjects completed study activities (range 92-98%). Discussion: A minority of publications reported participation data. One of the 13 studies published data on the race of participants, reporting 94% of participants were African American and 3% were Hispanic. However, since SCD predominantly affects African Americans (approximately 90% of those with SCD nationwide are African American and approximately 10% are Hispanic), it is reasonable to estimate that the subjects in our analysis represent a predominantly African American population. We acknowledge that subjects with SCD may not be representative of the US African American population in total. Nonetheless, our findings contradict the assertion that African Americans are less willing to participate in clinical trials, or that African Americans have disproportionately high drop-out rates. Only a minority of publications reported data required to calculate participation rates. Despite this limitation, available empiric evidence suggests that when participation in high-quality clinical trials is made available, African Americans demonstrate a willingness and capacity to enroll and complete study participation. The generalized assertion that African American patients' willingness to participate in research is a major factor in their underrepresentation in clinical trials is false. Researchers should design high-quality clinical trials that include this underrepresented group at the outset, and investigators should be encouraged to collect and report participation data more carefully so that this disparity can be measured and addressed. Disclosures No relevant conflicts of interest to declare.

Background: Sickle cell disease (SCD) in adolescents and young adults has been associated with low high school graduation rates. Complications of the disease may decrease school attendance, academic performance, and grade attainment. The graduation rate for patients with SCD enrolled in the Cooperative Study of Sickle Cell Disease (CSSD) was 71%. Poor educational outcomes might be due to a number of factors including socioeconomic status or days spent in the hospital due to illness. Neurological complications of SCD may also contribute. Stroke and microvascular ischemic events are detrimental to cognitive function and influence academic achievement and grade attainment. Patient and practitioner adherence to best practices, such as those described in the NHLBI 2014 guidelines vary widely, and the association of best practices with graduation rates has not been studied. We compared high school graduation rates of patients at Akron Children's Hospital Sickle Cell Disease Program (ACHSCDP) with national and local rates. Methods: We conducted a retrospective chart review of patients born between 1994 and 2000 who received care for all forms of SCD at ACHSCDP. Patients were identified through an onsite registry. Thirty-two patients were identified for chart review. We defined successful high school attainment as graduation from 12th grade, or having completed 11th grade by July 2018 and enrolled to begin 12th grade in Fall 2018, before or at 19 years of age. We determined successful high school attainment for patients at Akron Children's Hospital and assessed factors associated with success. Results: Patients born from 1994 to 2000 with sickle cell disease (SS, SC, SBeta-0, SBeta-+) were analyzed (n=32). Two patients transferred out of ACHSCDP prior to age 14 and were not included in our analysis. Of 30 patients studied, 14 were male and 16 were female. Twenty-six patients (86.7%) had graduated or were starting senior year as of July 2018. Of the 26 successful students, 12 (46.2%) had either an IEP or 504 (federally defined accommodation plan) in place. None of the 4 unsuccessful students had an IEP, however 1 student had a 504. Of the 26 successful students, 13 had HbSS, 1 had HbS/B o thal, 5 had HbS/B + thal, and 7 had HbSC. All 4 unsuccessful students had HbSS. Of the 26 successful students, clinical data from 4 years before graduation or 3 years before completion of the 11th grade revealed that the students were hospitalized an average of 5.77 days per year and visited the emergency department an average of 1.38 times per year. Of the 4 unsuccessful patients, data collected 4 years before the age of 19 revealed that the patients were hospitalized an average of 5.85 days per year and visited the emergency department an average of 1.37 times per year. Only one patient had a documented stroke, and this child successfully graduated from high school. Of the 26 successful students, 18 (69.2%) were enrolled in college after finishing high school and 3 students were in their senior year of high school. Discussion: In this cohort, a high percentage of patients (86.7%) graduated or were on track to graduate from high school. In the United States, approximately 90% of patients with SCD are African American. All patients analyzed here were African American. With this in mind, ACHSCDP patients' graduation rate compares favorably to estimated graduation rates across the US general population (84%), the U.S. African America population (76%), the U.S. sickle cell patient population (71%), the Ohio general population (84%), and the Ohio African American population (68%). The higher graduation rate among children at the ACHSCDP is associated with a multidisciplinary care model that prioritizes optimal hematologic care adhering to evidence based best practices including stroke risk screening and prevention, and use of hydroxyurea. In addition, team members assess for educations status and disease specific limitations at each encounter. A social worker advocates for educational needs. An outreach nurse makes school visits to educate staff and assist with implementation of federal accommodation plans. A teacher is available during inpatient stays to provide education in coordination with the patients' school. With comprehensive care, SCD is not a barrier to successful grade attainment, and academic distress in SCD patients should prompt re-evaluation of the patient's holistic medical care. Disclosures No relevant conflicts of interest to declare.