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Large-scale review of COVID-19 clinical trials highlights multiple disparities

Large-scale review of COVID-19 clinical trials highlights multiple disparities
Credit: Unsplash/CC0 Public Domain

Women were underrepresented in COVID-19 treatment clinical trials, and some racial and ethnic groups were underrepresented in COVID-19 prevention trials, according to a new meta-analysis conducted by Fred Hutchinson Cancer Center in collaboration with researchers from Beijing and London.

The study, published Dec. 5 in JAMA Internal Medicine, identified system-wide differences in representation among several key demographic groups in COVID-19 prevention and treatment trials in the U.S.

“To our knowledge, this is the first study to comprehensively examine demographic representation across the landscape of both COVID-19 prevention and treatment trials over the first two years of this pandemic,” said Hong Xiao, Ph.D., researcher in the Public Health Sciences Division at Fred Hutch and the lead author for the study.

By the numbers

Overall, the meta-analysis examined 122 U.S.-based clinical trials for COVID-19 vaccines or treatments, involving more than 175,000 participants. The selected trials were those registered on ClinicalTrials.gov or published in PubMed from October 2019 to February 2022.

Only studies that provided data about enrolled participants by sex, race or ethnicity were analyzed in this study. Representation rates from trials were compared to expected rates in the U.S. COVID-19 population.

Takeaways

Key findings from their review included:

  • Sex, race, and ethnicity were reported in 89.3{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}, 77.9{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}, and 71.3{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of U.S.-based COVID-19 clinical trials, respectively, suggesting there was a meaningful gap for many studies in this important aspect of trial reporting.
  • Female participants were underrepresented in treatment trials (85{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of expected participants) but were well represented in COVID-19 prevention trials.
  • Black and Asian individuals were underrepresented in COVID-19 prevention trials (53.7{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} and 64.4{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of expected participants, respectively), but were well represented in COVID-19 treatment trials.
  • Hispanic individuals were overrepresented in treatment trials (more than 200{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of expected participants).

Author commentary

The study authors noted that female participants historically have been underrepresented in clinical trials in general for various reasons. Pregnant women have routinely been excluded from clinical trials; as such, women of reproductive age may have had greater concerns about how developmental COVID-19 treatments would affect their health and current or future fertility.

The authors also speculated that Hispanic overrepresentation might have occurred for several reasons, including the fact that one-third of the U.S.-based COVID-19 trial sites were in California, Texas and Florida—areas with large Hispanic populations. Additionally, COVID-19 treatment trials were typically conducted among inpatient populations, which may have disproportionately affected Hispanic populations due to a lack of primary care and increased risk for COVID-associated hospitalizations.

“In many instances, our findings highlight achievements in the successful enrollment of historically underrepresented patients. However, our findings also underscore that despite efforts to eliminate sex, racial and ethnic disparities, gaps in reporting and differences in representation in U.S.-based COVID-19 trials have persisted,” said Joseph M. Unger, Ph.D., MS, Fred Hutch biostatistician and health services researcher and the study’s senior author. “Clearly, more progress needs to occur to fully close these gaps and achieve greater diversity among participants.”

Equitable access

“This vital work by Fred Hutch researchers and their collaborators highlights the ongoing disparities in who accesses and enrolls in clinical research,” added Rachel Bender Ignacio, MD, medical director of the COVID-19 Clinical Research Center at Fred Hutch. “We must remain laser-focused on ensuring that clinical-trial participation is representative of the general population, which both requires trust in and access to research, and also ensures that the products of that research are acceptable to and appropriate for everyone.”

Xiao, Unger and the rest of the study authors concluded that additional strategies are needed to ensure that all trial sponsors, whether federally supported or industry-funded, are held accountable for appropriate representation of females and racial and ethnic groups in clinical trials.

More information:
Hong Xiao et al, JAMA Internal Medicine (2022). DOI: 10.1001/jamainternmed.2022.5600

Provided by
Fred Hutchinson Cancer Center

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Large-scale review of COVID-19 clinical trials highlights multiple disparities (2022, December 5)
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WHO highlights oral health neglect affecting nearly half of the world’s population

A new Global Oral Health Status Report published today by the World Health Organization (WHO) provides the first-ever comprehensive picture of oral disease burden with data profiles for 194 countries, giving unique insights into key areas and markers of oral health that are relevant for decision-makers.

The report shows that almost half of the world’s population (45{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} or 3.5 billion people) suffer from oral diseases, with 3 out of every 4 affected people living in low- and middle-income countries. Global cases of oral diseases have increased by 1 billion over the last 30 years—a clear indication that many people do not have access to prevention and treatment of oral diseases.

“Oral health has long been neglected in global health, but many oral diseases can be prevented and treated with the cost-effective measures outlined in this report,” said WHO Director-General, Dr Tedros Adhanom Ghebreyesus. “WHO is committed to providing guidance and support to countries so that all people, wherever they live and whatever their income, have the knowledge and tools needed to look after their teeth and mouths, and to access services for prevention and care when they need them.”

Rapid increase of oral diseases

The most common oral diseases are dental caries (tooth decay), severe gum disease, tooth loss and oral cancers.  Untreated dental caries is the single most common condition globally, affecting an estimated 2.5 billion people. Severe gum disease  ̶  a major cause of total tooth loss  ̶  is estimated to affect 1 billion people worldwide.  About 380 000 new cases of oral cancers are diagnosed every year.

The report underscores the glaring inequalities in access to oral health services, with a huge burden of oral diseases and conditions affecting the most vulnerable and disadvantaged populations. People on low incomes, people living with disabilities, older people living alone or in care homes, those living in remote and rural communities and people from minority groups carry a higher burden of oral diseases.

This pattern of inequalities is similar to other noncommunicable diseases such as cancers, cardiovascular diseases, diabetes, and mental disorders. Risk factors common to noncommunicable diseases such as high sugar intake, all forms of tobacco use, and harmful use of alcohol all contribute to the global oral health crisis.

Barriers to delivering oral health services

Only a small percentage of the global population is covered by essential oral health services, and those with the greatest need often have the least access to services. The key barriers to delivering access to oral health services for all include:

  1. Oral health care requires high out-of-pocket expenditures. This often leads to catastrophic costs and significant financial burden for families and communities.
  2. The provision of oral health services largely relies on highly specialized providers using expensive high-tech equipment and materials, and these services are not well integrated with primary health care models.
  3. Poor information and surveillance systems, combined with low priority for public oral health research are major bottlenecks to developing more effective oral health interventions and policies.

Opportunities to improve global oral health

The report showcases many promising opportunities to improve the state of global oral health including:

  • adopting a public health approach by addressing common risk factors through promoting a well-balanced diet low in sugars, stopping use of all forms of tobacco, reducing alcohol consumption and improving access to effective and affordable fluoride toothpaste.
  • planning oral health services as part of national health and improving integration of oral health services in primary health care as part of universal health coverage.
  • redefining oral health workforce models to respond to population needs and expanding competencies of non-dental healthcare workers to expand oral health service coverage; and
  • strengthening information systems by collecting and integrating oral health data into national health monitoring systems.

“Placing people at the heart of oral health services is critical if we are to achieve the vision of universal health coverage for all individuals and communities by 2030,” said Dr Bente Mikkelsen, WHO Director for Noncommunicable Diseases.

She added: “This report acts as a starting point by providing baseline information to help countries monitor progress of implementation, while also providing timely and relevant feedback to decision-makers at the national level. Together, we can change the current situation of oral health neglect.”

 

Note to editors

To watch the launch event on Friday, 18 November from 14.00 – 15:30 CET, please register at  https://who.zoom.us/webinar/register/WN_hDqiDjW9TBm4fSVljj3zQw.

The Global Oral Health Status Report uses the latest available data from the Global Burden of Disease (GBD) project, the International Agency for Research on Cancer (IARC) and global WHO surveys. The report is directed at policymakers, practitioners, researchers, development agencies and members of the private sector and civil society. 

In 2022, the World Health Assembly adopted a global strategy on oral health with a vision of universal health coverage for oral health for all individuals and communities by 2030. A detailed action plan is under development to help countries translate the global strategy into practice. This includes a monitoring framework for tracking progress, with measurable targets to be achieved by 2030.