Abstract B136: Health related social needs of people with cancer underrepresented in clinical trials: Early experience of the Cancer Research Equity and Advocacy through Engagement Initiative (CREATE) clinical trial patient navigation program
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Abstract Background: Black and African Americans (AA) remain severely underrepresented in therapeutic oncology clinical trials (TOCTs) and have the highest cancer mortality rates compared to all other groups. Racially biased clinical trial offers, poor physician-patient communication, and social determinants of health largely contribute to these racial inequities. The UNC Lineberger CREATE Clinical Trial Patient Navigation (CTPN) program was established to advance racial equity in TOCT participation. The CTPN program entails clinical trial education, facilitating communication between patients and their medical/research team, identifying barriers to clinical trial participation and connecting patients to resources to address those barriers. Here we describe the health-related social needs and referrals made to address those needs. Methods: The CTPN program employed a targeted proactive approach to reach patients with a new cancer diagnosis who self-identified as Black/African American (AA) or were insured by Medicaid. The patient navigator used the electronic medical record (EMR) to review the oncologist's schedule to identify patients meeting the above criteria. Identified patients received a letter in the mail describing the CTPN program and were offered an in-person clinic visit and/or telephone call with the patient navigator. During these encounters, the patient navigator assessed clinical trial barriers including health-related social needs and made referrals to resources to help address these needs. The CTPN program was initially launched in the thoracic oncology clinic but later became available for direct referrals from all oncology groups. Results: In the first 18 months of the CTPN program, there were 292 patient encounters among183 unique patients who received navigation services. Most patients (83%) were identified through the EMR, 79% identify as Black or AA, 64% have Medicaid. Patients had a diagnosis of lung (62%), head and neck (18%), gynecological (9%), and breast (2%) cancers. Clinical trial related barriers and health-related social needs included lack of clinical trial knowledge (68%), housing (9%), transportation (26%), financial support (18%), and family/caregiver support (14%). CTPN program materials were provided to address clinical trial informational needs (78%), and referrals were made to assist with emotional (13%), logistical (20%), and financial (21%) needs. On average, 2 referrals were made per patient encounter. Conclusion: CTPN can engage Black/AA patients with cancer using a proactive EMR approach to identify patients and may help address health-related social needs to facilitate cancer care and potential clinical trial participation. Future work will evaluate the impact of CTPN on enrollment of Black/AAs in therapeutic cancer clinical trials. Citation Format: Ashley Rankin Collins, Hayley N. Morris, Lauren N. Matthews, Omar N. Buenaventura Gomez, Marjory Charlot. Health related social needs of people with cancer underrepresented in clinical trials: Early experience of the Cancer Research Equity and Advocacy through Engagement Initiative (CREATE) clinical trial patient navigation program [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B136.Keywords:
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Diversity, equity, inclusion, and antiracism (DEI-A) are critical to providing adequate health care to all populations. High-fidelity simulations and role-play scenarios allow students to experience caring for clients from diverse backgrounds. This article discusses the project development and implementation of a DEI-A simulation day placed in a community health clinical course.
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Equity
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large-scale multicentre clinical trials conducted by cooperative groups have generated a lot of evidence to establish better standard treatments. The Clinical Trials Act was enforced on 1 April 2018, in Japan, and it has remarkably increased the operational burden on investigators, but its long-term impact on cancer cooperative groups is unknown.
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MethodsClinical trials listed in the MFDS clinical trial registry from January 1 st , 2014 to December 31 st , 2016 were included in the analysis.Therapeutic areas were classified based on investigational product (IP) described in the study title by World Health Organization Anatomical Therapeutic Chemical (WHO-ATC) Classification System.If the IP code was not specified in the database, IP code was referred to ClinicalTrials.govregistry to classify therapeutic area.When reference was not found, the trial was counted as 'Other' .When IPs of different therapeutic area co-existed in a clinical trial, therapeutic area was selected in terms of relative importance considering the number of drugs and study purpose.Study phase of '0' , '1/2a' , '1/2' , '1' , '1/3' was coded as phase 1;'2/3' , '2a' , '2b' , '2' , '2b/3' was coded as phase 2; '3a' , '3b' , '3' , '3/4' was coded as phase 3; trials other than phase 1 to 4 and investigator-
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Abstract Objective This study assessed the state of PMD development by comparing PMD clinical trials to pediatric trials evaluating drugs and biologics, from 1999-2022. We hypothesized changes in numbers and types of PMD trials compared to drugs and biologics represent an indicator of PMD growth. Study Design www.clinicaltrials.gov was used to identify and quantify both PMD clinical trials and pediatric trials for drugs and biologics. Clinical specialty was also assessed. The institutions included were the seven children’s hospitals primarily affiliated with the FDA PDC grants program between 2018-2023. Results 243 PMD clinical trials were identified based on the year of initiation. The average number of PMD trials initiated per year per institution was 1.5. PMD trials significantly increased (p=0.0083) from 2014 onward compared to pediatric clinical trials for drugs and biologics, which demonstrated no significant change in trial initiation activity. A more than five-fold increase in PMD trials was observed from 2014-2018 compared to previous time periods, and there were 48% more PMD trials from 2019-2022 compared to 2014-2018. PMD trials represented 5% of clinical trials at the institutions studied. Conclusions While clinical trial activity for drug and biologic development remained stable from 1999-2022, initiation of PMD trials significantly increased. The present results suggest that clinical trials growth reflects increased PMD development. Accommodation and promotion of PMD clinical trial activity, which is still relatively small, by relevant programs and policies at the institutional and government levels may foster the advancement of PMD to further address unmet needs. Article Summary This article is an analysis of device trials performed at seven children’s hospitals affiliated with the FDA Consortia grants program between 1999 and 2022. What’s Known on This Subject There have been no prior studies of device trial activity at a cohort of children’s hospitals at academic medical centers. Over the past decade, FDA programs have been initiated to assist stakeholders in advancing the development of pediatric medical devices. What This Study Adds Pediatric device trials account for only 5% of total trials at the institutions studied. Of note, only half of these PMD trials (2.4% of total clinical trials) were sponsored by industry and likely seeking pediatric labeling.
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With the development of linnovative regulations on drug clinical trials in mainland China, the quantity and quality of drug clinical trials have gradually improved over the past decade. Based on the information of the clinical trials from the online drug clinical trial registration platform of National Medical Products Administration, we reviewed the data of drug clinical trials in mainland China from 2009 to 2020. A total of 8,593 clinical trials have been conducted during this period. The annual number of clinical trials has been increasing gradually, and peaked in 2017. There were 2,127, 1,051, 1,551, and 156 phases I, II, III, and IV clinical trials respectively. In addition, there were 3,441 bioequivalence studies. Trials for anti-tumor drugs ranked the highest (19.45%), followed by trials of drugs for infections and infestations (12.96%) and those for cardiovascular diseases (9.00%). Meanwhile the number of the clinical trial sites also increased annually. However, there were only 116 and 130 clinical trials of drugs for children and rare diseases respectively. The geographical distribution of the sites was uneven. This mapping review provides an overall look of clinical trials in China, which may be useful for domestic and international sponsors.
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Disparities in healthcare represent a failure in the equity domain of quality. Although disparities have been well documented, little has been written about how hospitals might use improved data collection and quality improvement techniques to eliminate disparities. This article describes early findings from the planning phase of the first hospital-based disparities collaborative. The authors also discuss the changes in policy and practice that may speed hospitals in placing disparities and equity on their quality agendas.
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The field of health disparities and subsequently health equity has origins in the study of differences in health status and outcomes between African American and White populations. As a result, the literature surrounding health disparities and health equity among African Americans is arguably the most robust of any population-specific health disparity group. African American populations remain severely impacted by macrolevel structural issues that lead to many health disparities. This chapter summarizes the multilevel factors influencing the presence of health disparities for African Americans. It also summarizes several of the most studied disparities, examining the cause-specific health determinants, outcome disparities, and cause-specific recommendations for intervention and prevention work. The chapter describes the ways in which social determinants of health play a role in the existence and persistence of African American health disparities. It concludes with a discussion of specific approaches to advance health equity among African Americans.
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