Race and Ethnicity Representation in Clinical Trials: Findings from a Literature Review of Phase I Oncology Trials

Camidge, D. Ross; Park, Haeseong; Smoyer, Karen E.; Jacobs, Ira; Lee, Lauren J.; Askerova, Zemfira; McGinnis, Justin M.; Zakharia, Yousef

doi:10.2217/fon-2020-1262

Cited by 34 publications

(27 citation statements)

References 23 publications

(20 reference statements)

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“…We were unable to perform analysis on sexual partner histories or socioeconomic status, as too few studies reported these variables. HPV-associated OPSCC differs drastically from other cancers in its incidence amongst Caucasians relative to non-Caucasians; whereas Camidge et al reported that African American men are more likely to have malignant tumors and lower rates of survival than the general population, Pytynia et al found that the stark preponderance of HPV-associated OPSCC in Caucasian males over the general population actually contributes to the diminishment in cancer-related disparities between Caucasian and African American males [ 44 , 48 ]. Although Kennedy-Martin et al found that RCT participant populations are highly selective and have lower risk profiles than that of the general population, they did so in the context of cardiology, mental health, and general oncology [ 49 ].…”

Section: Discussionmentioning

confidence: 99%

Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis of Clinical Trial Demographics

Gordis

Cagle

Nguyen

et al. 2022

Cancers

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The objective of our paper was to answer the following question: how do patients with HPV-related oropharyngeal squamous cell carcinoma OPSCC (Population) enrolled in clinical trials (Intervention), compared with national database reports of HPV-associated OPSCC patients (Comparison), present demographically (Outcome)? We conducted a systematic review and meta-analysis of studies pertaining to clinical trials of HPV-associated OPSCC and participant demographics in the United States. PubMed, Scopus, CINAHL, and the Cochrane Library were searched from inception to 2 February 2022. Studies of overlapping participant cohorts and/or studies conducted outside of the United States were excluded. Primary outcomes were patient age, sex, and race. Secondary outcomes were smoking history, alcohol history, history of prior cancer, and tumor origin site. Meta-analysis of single means (mean, N for each study, and standard deviation) for age, pack years, and smoking years was performed. Pooled prevalence rates of gender, race, alcohol history, tobacco history, and tumor origin site were expressed as a percentage, with 95% confidence intervals. Meta-analysis found patients to be predominately non-smoking white males, with tumors originating from the tonsil. Our findings reflected the demographics reported by the National Cancer Database (NCDB) for HPV-associated OPSCC. This indicates that HPV-associated OPSCC patients are appropriately represented in clinical trial demographics.

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Section: Discussionmentioning

confidence: 99%

Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis of Clinical Trial Demographics

Gordis

Cagle

Nguyen

et al. 2022

Cancers

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“…Gender and phase 1 clinical study enrollment trends should be taken into consideration to provide a better insight into gender equity and accessibility to innovative therapeutic agents for the general population, as well as for children and the elderly, which will surely benefit from new commercialized drugs [ 33 ].…”

Section: Discussionmentioning

confidence: 99%

Trends of Phase I Clinical Trials in the Latest Ten Years across Five European Countries

Tonno

Perlin

Loiacono

et al. 2022

IJERPH

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Background: Phase 1 clinical trials represent a critical phase of drug development because new candidate therapeutic agents are tested for the first time on humans. Therefore, international guidelines and local laws have been released to mitigate and control possible risks for human health in agreement with the declaration of Helsinki and the international Good Clinical Practice principles. Despite numerous scientific works characterizing the registered clinical trials on ClinicalTrials.gov, the main features and trends of registered phase 1 clinical trials in Europe have not been investigated. This study is aimed at assessing the features and the temporal trend of distribution of phase 1 clinical studies, carried out in the five largest European countries over a ten-year period (2012–2021), and to evaluate the impact of the Italian regulatory framework on the activation of such studies. Methods: The main data and characteristics of phase 1 clinical studies registered on the ClinicalTrials.gov database for France, Germany, Italy, Spain and the United Kingdom have been investigated and subsequently compared. The above-mentioned countries were selected based on similarities in terms of demographic and Gross Domestic Product (GDP) data available on official government websites. (3) Results: A total number of 6878 phase 1 clinical trials were registered for the five selected countries in the ClinicalTrials.gov database during the ten years analyzed; the studies were predominantly randomized (39.33%) and for-profit (76.64%). The most represented area of investigations was oncology (52.15%), followed by hematology (24.99%) and immunology (12.04%). The variability observed between the analyzed countries showed that the UK, Germany and France presented the highest reduction in the number of phase 1 clinical trials, while for Spain and Italy, a stable/increased trend was observed, although with a lower number of trials registered on the ClinicalTrials.gov database. (4) Conclusions: Italy displayed the lowest number of registered phase 1 clinical trials, even though it showed a stable trend over the years. In this regard, the Italian regulatory framework must urgently be adapted to that of other European countries (Spain has been the first country to implement the new Regulation (EU) No 536/2014) and streamline the process of clinical trial application to increase the attractiveness of the country. Moreover, nonprofit phase 1 clinical trials (which represent 19.81% of the total number of phase 1 clinical trials registered in Italy vs. 80.19% of profit phase 1 clinical studies) should be promoted and supported by the institutions, even from a financial point of view, to allow independent researchers to develop new therapeutic drugs.

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“…For example, an analysis of global phase-1 trials of biopharmaceutical oncology agents showed that 62% of the participants were White. In the USA, 82.4% of the population was White, 7.3% were AAs, 3.4% were Asians, and 2.8% were Hispanic/Latinos and other races [ 70 ]. The underrepresentation of marginalized populations may undermine the generalizability of the trial findings and mask the heterogeneity of outcomes adverse events.…”

Section: Opportunities For Improvementmentioning

confidence: 99%

Disparities in Cardio-oncology: Effects On Outcomes and Opportunities for Improvement

et al. 2022

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Purpose of Review The purpose of this article is to provide a comprehensive review of available data on health disparities and the interconnected social determinants of health (SDOH) in cardio-oncology. We identify the gaps in the literature and suggest areas for future research. In addition, we propose strategies to address these disparities at various levels. Recent Findings There has been increasing recognition of health disparities and the role of SODH on an individual’s access to health care, quality of care, and outcomes of the illness. There is growing evidence of sex and race-based differences in cancer therapy-related cardiotoxicity. Recent studies have shown how access and quality of health care are affected by financial stability and rurality. Our recent study utilizing the social vulnerability index (SVI) and county-level patient data found graded increase in county-level cardio-oncology mortality with greater social vulnerability. The incremental impact of social vulnerability was higher for cardio-oncology mortality than for mortality related to either cancer or CVD alone. The mortality rates in these patients were higher in rural areas compared to urban areas regardless of social vulnerability. Additionally, for those within the counties within highest social vulnerability, Black individuals had significantly higher cardio-oncology mortality compared with White individuals. Summary Disparities in the cardio-oncology population are deep-rooted and widespread, leading to poor quality of life and increased mortality. It is crucial to integrate SDOH, not only in clinical care delivery but also in future research, and registry data to improve our understanding and the outcomes in our unique subset of cardio-oncology patients.

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Race and Ethnicity Representation in Clinical Trials: Findings from a Literature Review of Phase I Oncology Trials

Cited by 34 publications

References 23 publications

Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis of Clinical Trial Demographics

Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis of Clinical Trial Demographics

Trends of Phase I Clinical Trials in the Latest Ten Years across Five European Countries

Disparities in Cardio-oncology: Effects On Outcomes and Opportunities for Improvement

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