Increasing Diversity in Clinical Trials: Overcoming Critical Barriers

Clark, Luther T.; Watkins, Laurence O.; Piña, Ileana L.; Elmer, M.; Akinboboye, Ola; Gorham, Millicent; Jamerson, Brenda D.; McCullough, Cassandra; Pierre, Christine; Polis, Adam B.; Puckrein, Gary; Regnante, Jeanne M.

doi:10.1016/j.cpcardiol.2018.11.002

Cited by 479 publications

(506 citation statements)

References 26 publications

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“…Specifically, by incorporating FS limitations, the NHA model predicted that patients with APD were 1.5-times as likely to be admitted to a nursing home as patients with non-advanced PD, who were in turn 3-times as likely to be admitted to a nursing home relative to patients without PD. Because the MCBS data are nationally representative, these results are generalizable to the broader elderly population, with the caveat that the impact of treatment is based on clinical trial results in a controlled setting, not observational data 18,19 . A follow-on analysis after sufficient real-world LCIG data are available would be a welcome addition to these findings.…”

Section: Discussionmentioning

confidence: 99%

The effect of functional status impairment on nursing home admission risk among patients with advanced Parkinson’s disease

Shih¹,

Sail

Jalundhwala

et al. 2019

Journal of Medical Economics

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Aims: To estimate the relationship between functional status (FS) impairment and nursing home admission (NHA) risk in Parkinson's disease (PD) patients, and quantify the effect of advanced PD (APD) treatment on NHA risk relative to standard of care (SoC). Materials and methods: PD patients were identified in the Medicare Current Beneficiary Survey (MCBS) (1992-2010). A working definition based on the literature and clinical expert input determined APD status. A logit model estimated the relationship between FS impairment and NHA risk. The effect of levodopa-carbidopa intestinal gel (LCIG) on NHA risk relative to SoC was simulated using clinical trial data (control: optimized oral levodopa-carbidopa IR, ClinicalTrials.gov NCT00660387 and NCT0357994). Results: Non-advanced PD and APD significantly increased NHA risk when controlling for demographics (p < 0.01). APD status was no longer significant after controlling for FS limitations, implying that FS limitations explain the increased NHA risk in APD patients. Reduced impairment in FS in patients with APD treated with LCIG reduced risk of NHA by 13.5% relative to SoC. Limitations: This study applies clinical trial results to real-world data. LCIG treatment might have a different effect on NHA risk for the nationally representative population than the effect measured in the trial. Both data sources employ different instruments to measure FS, instrument wording and study follow-up differed, which might bias our estimates. Finally, there lacks consensus on a definition of APD. The prevalence of APD in this study is high, perhaps due to the specific definition used. Conclusions: Patients with APD experience a higher risk in NHA than those with non-advanced disease. This increased risk in NHA in patients with APD is explained by greater limitations in FS. The relative reduction in risk of NHA for the APD population treated with LCIG is quantitatively similar to doubling Medicaid home care services.

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Section: Discussionmentioning

confidence: 99%

The effect of functional status impairment on nursing home admission risk among patients with advanced Parkinson’s disease

Shih¹,

Sail

Jalundhwala

et al. 2019

Journal of Medical Economics

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“…Limitations to stratify public data with correlated demographic data and missing survival data in our cohort preclude definitive actionable clinical conclusions at this time. Although there are ongoing efforts to recruit minorities into existing clinical trials [86,87], these findings highlight the impactful possibilities of utilizing genetic ancestry in multi-ethnic cohorts and the need to demonstrate that variation within and among TNBC subtypes and how genetic ancestry may impact tumor biology, which in could guide treatment decisions. Author Contributions: UM, CY, and MD contributed to the concept, design, and generating; MD, CY, RM, ID, IA, and JW performed the data curation and analyses; IEE, ARF, WG, UM collected breast tissues; IEE, ARF, and WEG performed macro-dissections; MD, CY, RT, WDC, UM, and WG wrote and edited the manuscript.…”

Section: Discussionmentioning

confidence: 99%

Identification of Distinct Heterogenic Subtypes and Molecular Signatures Associated With African Ancestry in Triple Negative Breast Cancer Using Quantified Genetic Ancestry Models in Admixed Race Populations

Davis¹,

Martini²,

Newman³

et al. 2020

Preprint

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Triple negative breast cancers (TNBCs) are molecularly heterogeneous, and the link between their aggressiveness with African ancestry is not established. We investigated primary TNBCs for gene expression among self-reported race (SRR) groups of African American (AA, n=42) and European American (EA, n=33) women. Using The Cancer Genome Atlas (TCGA) approaches, we analyzed RNA sequencing data to measure changes in genome-wide expression and used logistic regressions to identify ancestry-associated gene expression signatures. To determine global ancestry, GATK best practices were followed for variant calling, and used the 1000 Genomes Project as reference data. We identified >150 African ancestry-associated genes and found that, compared to SRR, quantitative genetic analysis was a more robust method to identify racial/ethnic-specific genes that were differentially expressed. A subset of African ancestry-specific genes that were upregulated in TNBCs of our AA patients were validated in TCGA data. In AA patients, there was a higher incidence of basal-like 2 tumors and altered TP53, NFB1, and AKT pathways. The distinct distribution of TNBC subtypes and altered oncologic pathways show that the ethnic variations in TNBCs are driven by shared genetic ancestry. Thus, to appreciate the molecular diversity of TNBCs, tumors from patients of various ancestral origins should be evaluated.

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“…Developing the knowledge, skills, and attitudes of inspectors so they can perform their jobs competently-safely, effectively, and efficiently-is important in any endeavor. When it comes to clinical trials involving human subjects, ensuring that international ethical principles are observed, that the rights, integrity and confidentiality of trial subjects are respected and protected, and that clinical trial data are collected in a reliable and valid manner, the competency of professional staff responsible with oversight of good clinical practices is exceptionally critical because failures can have devastating effects (Clark et al 2019;Eichler and Sweeney 2018).…”

mentioning

confidence: 99%

Creating a “Good Clinical Practices Inspection” Authentic Online Learning Environment through Educational Design Research

Kartoğlu¹,

Siagian²,

Reeves

2020

TechTrends

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Educational design research (EDR) was applied to address the challenge of providing more public health professionals with opportunities to develop their knowledge and skills related to Good Clinical Practices (GCP) inspections. The conduct of clinical research in accordance with the principles of GCP is necessary to ensure that clinical research participants are not exposed to undue risk, and that data generated from the research are valid and accurate. The safety and efficacy of pharmaceuticals, medical devices, and other healthcare products depend upon the application of GCP. The World Health Organization has been providing a global face-to-face GCP Inspection course in Indonesia for a decade, but budget constraints only allow this course to be offered once a year to 15 participants. This paper describes how the move from a face-to-face course to an online authentic learning environment was accomplished through EDR and concludes with a discussion of design principles derived from the research. The results of a beta test of the new online course with 12 participants are also described in the paper.

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Increasing Diversity in Clinical Trials: Overcoming Critical Barriers

Cited by 479 publications

References 26 publications

The effect of functional status impairment on nursing home admission risk among patients with advanced Parkinson’s disease

The effect of functional status impairment on nursing home admission risk among patients with advanced Parkinson’s disease

Identification of Distinct Heterogenic Subtypes and Molecular Signatures Associated With African Ancestry in Triple Negative Breast Cancer Using Quantified Genetic Ancestry Models in Admixed Race Populations

Creating a “Good Clinical Practices Inspection” Authentic Online Learning Environment through Educational Design Research

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