Announcements have been made that Moderna, the University of Oxford and AstraZeneca, and Johnson & Johnson independently of one another will begin testing proposed coronavirus vaccines in stage three trials beginning in July 2020. Related to the important matter of whether these attempts or any related investigations will yield products that protect against the onset of COVID-19 is the essential question of which kinds of individuals will benefit from this research. Key demographic characteristics, such as age, gender, and race/ethnicity help to distinguish one person from another. Unless the pool of participants in these clinical trials adequately reflects such differences, then the overall impact of any vaccine may be limited to representatives of groups taking part in such studies.
Major shortcomings presently exist in the composition of participants in clinical trials. As reported in the March 2020 issue of the journal Contemporary Clinical Trials Communications, adult participation in U.S. cancer clinical trials is at less than 10% of cancer patients, with even lower rates for racial and ethnic minority groups. For example, African Americans comprise 5% of patients enrolled in trials that support FDA approval of new drugs, while representing 13.3% of the general U.S. population. Cancer is the leading cause of death for Asian Americans, yet they comprise just 3% of cancer participants in clinical trials. Also, Hispanics represent less than 3% of participants in similar investigations, despite accounting for an estimated 17.8% of the U.S. population.
An under-representation of older adults in cancer clinical trials remains an ongoing concern. Consequently, optimal treatment in this group remains undefined. The January 2020 issue of the Journal of Geriatric Oncology describes challenges involving efforts to increase their level of participation. Older adult cancer patients, differ from younger adults since they often possess more comorbidities, take more medications, and have diminishing organ function, which often excludes them from clinical investigations. Furthermore, older adults enrolled in studies tend to be fitter and healthier than the average older patient seen in clinics, which leads to uncertainty about the risks, benefits, and tolerability of systemic therapies in the older population.
Potential barriers to enrollment of older adults in trials have been identified. One reason for non-accrual of older adults is due to trial unavailability or patient ineligibility. Strict exclusion criteria, especially those related to functional status, organ function, and comorbidities, which are common in older patients, can serve as major enrollment barriers.
Mortality data for victims of the COVID-19 epidemic show that some portions of the U.S. population have been devastated more than other demographic segments. Patients 80 years of age and older residing in long-term care facilities have been particularly hard hit. African American males also have died at significantly higher rates than their proportion of the population would suggest. Thus, it would be most prudent to ensure that stage three vaccine trials represent these groups adequately.
More June 2020 TRENDS Articles
COVID-19 VACCINE CLINICAL TRIAL CONCERNS
Indicates the importance of ensuring that key demographic groups experiencing the ravages of this disease are represented adequately in upcoming stage three clinical trials. Read More
PRESIDENT’S CORNER
ASAHP President Phyllis King discusses leadership during a time of change with a focus on helping academic teams with transition by working with campus administration to clarify the vision and establish structures that support change. Read More
EFFECTIVE CORONAVIRUS MESSAGES FROM ACADEMIC INSTITUTIONS
Identifies the top five communicators based on frequency and consistency of mention according to an annual Student Sentiment Survey conducted by the firm Eduventures. Read More
CONGRESS IN A TIME OF CORONAVIRUS
Contains some details about an initiative by U.S. senators to increase access to telehealth because of its potential to expand availability of health care, reduce costs, and improve health outcomes. Read More
HEALTH REFORM DEVELOPMENTS
Points out how Medicare is on an unsustainable trajectory and identifies fundamental changes that must be addressed in the federal-state Medicaid program. Read More
DEVELOPMENTS IN HIGHER EDUCATION
Describes how doubts and uncertainties are affecting decisions on whether to reopen schools at all academic levels and some thoughts on how to rethink accreditation and quality assurance. Read More
QUICK STAT (SHORT, TIMELY, AND TOPICAL)
Prevalence Of Tooth Loss Among Older Adults, 2015-2018
Opioid-Involved Emergency Department Visits, Hospitalizations, And Deaths
Personalized Mapping Of Drug Metabolism By The Human Gut Microbiome
Magnetoelectric Materials For Miniature, Wireless Neural Stimulation At Therapeutic Frequencies Read More
AVAILABLE RESOURCES ACCESSIBLE ELECTRONICALLY
Advancing Adolescent Flourishing: Moving Policy Upstream
Preparing For The Next Pandemic
New Data On Community Resilience In The Face Of Disasters Read More
NIH FUNDING AND THE PURSUIT OF EDGE SCIENCE
Reveals the degree to which the NIH is successful in funding work with novel ideas, known as “edge science,” and some reasons why support for this endeavor is not as robust as it could be. Read More
TRANSHUMANISM AND THE PROSPECT OF NEVER HAVING TO DIE
Enthusiasm persists in some quarters that human death can be overcome, but at least in the short term, that quest still has a considerable way to go to reach fruition. Read More