Access Denied: Inequities in Clinical Trial Enrollment for Pancreatic Cancer

Eskander, Mariam F.; Gil, Lindsay A.; Beal, Eliza W.; Li, Yaming; Hamad, Ahmad; Oppong, Bridget A.; Obeng‐Gyasi, Samilia; Tsung, Allan

doi:10.1245/s10434-021-10868-4

Cited by 19 publications

(11 citation statements)

References 61 publications

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“…Although racial and ethnic disparities in EF were mitigated in the subset of US-only trials, this accounted for a minority of all clinical trial participants, and gender disparities persisted. Our findings are consistent with studies in other cancers 12,13 and emphasize the need for interventions to ensure PLC trial demographics better reflect the at-risk population.…”

Section: Discussionsupporting

confidence: 88%

Gender, Age, Racial and Ethnic Disparities in Clinical Trial Enrollment for Primary Liver Cancer

et al. 2022

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Section: Discussionsupporting

confidence: 88%

Gender, Age, Racial and Ethnic Disparities in Clinical Trial Enrollment for Primary Liver Cancer

et al. 2022

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“…Even as enrollment increased during this study secondary to vigorous recruitment efforts, this increase in numbers was not demonstrated among African American patients and for patients on Medicaid. 12…”

Section: The Importance Of Real-world Patient Data and Inequities In ...mentioning

confidence: 99%

Clinical trial reform in the post-COVID era

Mahoney

Sridhar

2023

Ther Adv Med Oncol

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The COVID-19 pandemic precipitated the acute and efficient rollout of telehealth and virtual health care around the world. This review article focuses on the adoption of virtual care in the management of oncology patients, and discusses how virtual care offers the potential for large-scale, positive impacts on access to clinical trials. Virtual care during and following the peak of the pandemic has been found to be both safe and efficacious for oncology patients. Features, such as wearable health technologies, remote monitoring, home visits, and investigations being done closer to home, represent just some of the strengths of the virtual assessment rollout that were successfully utilized. One of the primary criticisms of oncological clinical trials is that clinical trial participants are not always representative of the patient populations treated in routine practice. This is in part due to stringent inclusion criteria and more broadly pertains to a lack of access to clinical trials, many of which are geographic as most trials are conducted in an urban, academic, or ‘centralized’ center. This paper seeks to discuss the barriers to clinical trial participation and to propose that the virtual care transformation that occurred during the pandemic has equipped oncological clinicians and researchers with the tools to better address these obstacles. A review of the literature on the impact of the virtual care rollout during and after the peak of the COVID-19 pandemic both locally and abroad was conducted. It is proposed that improving patient access through the decentralization of clinical trials has the potential to enhance evidence-based, real-world data, and to produce generalizable trial results that ultimately improve patient outcomes.

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“…Nonetheless, many logistical challenges exist, including financial complexities, transportation across state or country borders, and regulatory barriers. While these challenges have received substantial attention in other fields of research, such as clinical trials for cancer and other disease areas [ 184 , 185 , 186 , 187 , 188 , 189 , 190 , 191 , 192 , 193 , 194 , 195 , 196 , 197 ], their role in DoC research studies has been relatively underexplored and represents a vital area for ongoing advocacy and investigation. Initiatives to enhance equity in clinical-trial enrollment, including resources to promote diverse and inclusive enrollment and training for researchers, have been made available by FDA [ 198 ].…”

Section: Advancing Equity In Doc Clinical Trial Access and Enrollmentmentioning

confidence: 99%

Ethical Considerations in Clinical Trials for Disorders of Consciousness

2022

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As the clinical trial landscape for patients with disorders of consciousness (DoC) expands, consideration of associated ethical challenges and opportunities is of ever-increasing importance. Responsible conduct of research in the vulnerable population of persons with DoC, including those with coma, vegetative state/unresponsive wakefulness syndrome (VS/UWS), minimally conscious state (MCS), covert cortical processing (CCP), and cognitive motor dissociation (CMD), demands proactive deliberation of unique ethical issues that may arise and the adoption of robust protections to safeguard patients, surrogates, and other key stakeholders. Here we identify and critically evaluate four central categories of ethical considerations in clinical trials involving participants with DoC: (1) autonomy, respect for persons and informed consent of individuals with liminal consciousness; (2) balancing unknown benefits and risks, especially considering the epistemological gap between behavior and consciousness that complicates ordinary ascription of subjective states; (3) disclosure to surrogates and clinical teams of investigational results pertaining to consciousness; and (4) justice considerations, including equitable access to clinical trial enrollment across communities and geographies. We outline guiding principles and research opportunities for clinicians, neuroethicists, and researchers engaged in DoC clinical trials to advance ethical study design and deployment in this complex yet crucial area of investigation.

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Access Denied: Inequities in Clinical Trial Enrollment for Pancreatic Cancer

Cited by 19 publications

References 61 publications

Gender, Age, Racial and Ethnic Disparities in Clinical Trial Enrollment for Primary Liver Cancer

Gender, Age, Racial and Ethnic Disparities in Clinical Trial Enrollment for Primary Liver Cancer

Clinical trial reform in the post-COVID era

Ethical Considerations in Clinical Trials for Disorders of Consciousness

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