Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials.

BACKGROUND: Whereas anecdotal reports suggest that the use of decentralized clinical trial (DCT) solutions can improve participant diversity in clinical trials there is no quantitative evidence to support such reports. METHODS: Tufts CSDD conducted this initial study based on data collected from prior research and publicly available data drawn from Clinicaltrials.gov to compare and contrast participant diversity in trials which included various DCT solutions - virtual visits or televisits, home visits, devices or wearables, and the use of local labs. RESULTS: The results of this analysis indicate that the use of local labs is associated with a lower percentage of white participants; the use of virtual visits or televisits is associated with a lower percentage of Black participants; and the use of devices or wearables was not associated with any significant change in participant demographics. The use of home visits could not be tested for significant differences.

Illuminating the landscape of high-level clinical trial opportunities in the All of Us Research Program.

OBJECTIVE: With its size and diversity, the All of Us Research Program has the potential to power and improve representation in clinical trials through ancillary studies like Nutrition for Precision Health. We sought to characterize high-level trial opportunities for the diverse participants and sponsors of future trial investment. MATERIALS AND METHODS: We matched All of Us participants with available trials on ClinicalTrials.gov based on medical conditions, age, sex, and geographic location. Based on the number of matched trials, we (1) developed the Trial Opportunities Compass (TOC) to help sponsors assess trial investment portfolios, (2) characterized the landscape of trial opportunities in a phenome-wide association study (PheWAS), and (3) assessed the relationship between trial opportunities and social determinants of health (SDoH) to identify potential barriers to trial participation. RESULTS: Our study included 181 529 All of Us participants and 18 634 trials. The TOC identified opportunities for portfolio investment and gaps in currently available trials across federal, industrial, and academic sponsors. PheWAS results revealed an emphasis on mental disorder-related trials, with anxiety disorder having the highest adjusted increase in the number of matched trials (59% [95% CI, 57-62]; P < 1e-300). Participants from certain communities underrepresented in biomedical research, including self-reported racial and ethnic minorities, had more matched trials after adjusting for other factors. Living in a nonmetropolitan area was associated with up to 13.1 times fewer matched trials. DISCUSSION AND CONCLUSION: All of Us data are a valuable resource for identifying trial opportunities to inform trial portfolio planning. Characterizing these opportunities with consideration for SDoH can provide guidance on prioritizing the most pressing barriers to trial participation.

Inclusion of Subjects who are Obese in Drug Development: Current Status and Opportunities.

The prevalence of obesity has grown tremendously in recent years and this population has an increased risk of disease comorbidities. The presence of disease comorbidities requires treatment interventions and proper dosing guidelines. However, drug development programs often do not have adequate representation of individuals who are obese in clinical trials, leaving gaps in the understanding of treatment response leading to a lack of adequate individualization options. Based on a recent survey of approved drug product package inserts, very few approved products included specific dosing based on obesity, in both adults and pediatrics. Reasons for the limited information on patients who are obese may include the under-reporting of information regarding such patients and a lack of clinical trial diversity in enrolling patient groups in whom obesity or obesity-related comorbidities are more prevalent. An inadvertent impact of the practice of exclusion of subsets of patients with some comorbidities in clinical trials may play a role in the reduced enrollment of individuals who are obese. Recently, regulatory authorities have taken specific initiatives to promote clinical trial diversity, including engaging with stakeholders and publishing regulatory guidance. These guidance documents highlight the need to enroll diverse clinical trial populations and provide recommendations on concepts related to drug development for obese populations. Such efforts will help to address the gap in information regarding drug response and dosing in patients who are obese.

The influence of political ideology on clinical trial knowledge, invitation, and participation among adults in the United States.

BACKGROUND: Clinical trials remain a critical component of medical innovation. Evidence suggests that individuals' political ideologies may impact their health behaviors. However, there is a paucity of literature examining the relationship between political ideologies and clinical trial knowledge and participation. METHODS: Study data were derived from Health Information National Trends Survey 5 Cycle 4 (n = 3300), which was conducted from February to June 2020. We used participants' characteristics to estimate the prevalence of clinical trial knowledge and participation. We used multivariable logistic regressions to investigate whether political ideology had a significant impact on clinical trial knowledge and participation. Jack-knife replicate weights were applied for population-level estimates. RESULTS: Most participants were White (64.2%), earned above US$50,000 (62.4%), and lived in urban areas (88.0%). About 59.2% reported having some knowledge of clinical trials, and only 8.9% had ever been invited to participate in clinical trials. A total of 37.0%, 29.5%, and 33.5% of the population endorsed moderate, liberal, and conservative political viewpoints respectively. In the adjusted logistic regression analysis, compared to conservatives, liberals (adjusted odds ratio, 1.92; 95% confidence interval, 1.31-2.80) and moderates (adjusted odds ratio, 1.43; 95% confidence interval, 1.09-1.88) had significantly greater odds of having knowledge of clinical trials. Also, liberals had higher odds of receiving invitations to participate in clinical trials (odds ratio, 1.76; 95% confidence interval, 1.08-2.85; p = 0.023) and greater odds of trial participation (odds ratio, 3.90; 95% confidence interval, 1.47-10.33; p = 0.007) compared to moderates. CONCLUSIONS: The mechanism underlying the higher rates of clinical trial invitations to liberals is unclear and requires further comprehensive investigation. Similarly, further qualitative studies are needed to understand the attributes that promote knowledge and increased likelihood of clinical trial participation among liberals. This will provide crucial insight to help design interventions that further involve conservatives and moderates in clinical trials and scientific enterprise.

A Protected Class, An Unprotected Condition, and A Biomarker - A Method/Formula for Increased Diversity in Clinical Trials for the African American Subject with Benign Ethnic Neutropenia (BEN).

Expanding on previous industry guidance relative to increased clinical trial diversity, while honing more exacting treatments and better ways to fight diseases that have often disproportionately impacted people of color, is a topic being discussed by multidisciplinary public health experts across the nation.This writing draws attention to the African American demographic, which is continually subject to health care disparities. Any glimpses of knowledge or medical discovery that could potentially help to redress harm or reinforce a weakened familial-cultural infrastructure should be emphasized for sanative restoration of the impacted communities. The focus of this writing is the African American cohort and its nexus to Benign Ethnic Neutropenia as the diverse target population of discussion, hoping to convey a harmonized approach in the examination of (1) the African American Benign Ethnic Neutropenia cohort within the context of basic scientific understanding, (2) the interplay of applicable governing regulatory protections, and (3) increased clinical trial participation to enlarge the pathway for increased diversity in clinical trials.

Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity.

BACKGROUND: There is little to no empirical data on the race and ethnicity of the global community of professionals conducting clinical trials funded by pharmaceutical and biotechnology companies and little empirical evidence on the relationship between the race and ethnicity of investigative site personnel and the overall and corresponding diversity of participants enrolled. METHODS: A global online survey conducted in mid-2021 gathered responses from 3462 clinical research professionals representing approximately 3300 distinct investigative sites. RESULTS: Worldwide, including all research settings, the majority (64%) of investigative site personnel are White, 20% are LatinX, 6% are Black, 7% are Asian and 3% are other races and ethnicities (e.g., indigenous peoples, Pacific Islander, Middle Eastern, etc.). The representation of non-white site personnel is significantly higher in North America and Rest of World (ROW) compared to Europe. The highest levels of personnel diversity are found in private community-based practices, investigative sites and site networks. A significant correlation (p < 0.001) was found between site personnel diversity and patient enrollment diversity worldwide. As the mix of site personnel by race and ethnicity increases, the diversity of patients enrolled-except for Asian patients in sites outside of North America-also increases. A significant relationship was also found between the proportion of a given race or ethnicity of investigative site personnel and the corresponding race and ethnicity of patients enrolled. CONCLUSIONS: An opportunity exists to address under-representation in clinical trials through identifying, hiring and supporting investigative site personnel to best reflect the patient communities that they serve.

Drug Information Association (DIA) 2021 Global Annual Meeting (June 26-July 1, 2021 - Virtual Meeting).

At the 57th Global Annual Meeting of the Drug Information Association (DIA), attendees met virtually for the second time to support the theme of 'Collaboration without Boundaries.' Sessions included presenters and speakers from regulatory agencies, patient advocacy and academia, with patients at the forefront of discussions. This report covers a number of presentations and panel discussions from the 4-day meeting that primarily focused on the COVID-19 global pandemic.

The State of Lupus Clinical Trials: Minority Participation Needed.

In the United States, the reported prevalence of lupus is 100,000 to 500,000 patients. Lupus disproportionately affects minority populations, including African Americans and Latinos, and the associated health disparities are substantial. Women are at a higher risk of lupus than men and lupus prevalence is the highest in African Americans and Latinos compared to non-Hispanic whites. African Americans and Latinos also have increased disease symptom severity, experience more lupus-related complications, and have a two- to three-fold mortality rate compared to non-Hispanic Whites. Lupus clinical trials offer opportunities for quality care and can result in new treatment options, but African Americans and Latinos are underrepresented in clinical trials because of substantial patient- and provider-side barriers. In conjunction with the limited knowledge of clinical trials that potential participants may have, the healthcare staff approaching participants have limited time to adequately educate and explain the aspects of clinical trials. Indeed, ninety percent of clinical trials fail to meet their recruitment goals on time, so a multi-faceted approach is necessary to address the issue of low minority participation in clinical trials.