HEOR News

The Future of the Global Clinical Trial Ecosystem: A Vision From the First WHO Global Clinical Trials Forum (The Lancet)

Clinical trial approval procedures require urgent reform, according to those gathered last November at the first WHO Global Clinical Trials Forum. “Those engaged in trials must first ensure optimal scientific and ethical design, by focusing on questions that are relevant to diverse patients and communities and making sure pivotal aspects such as sample size, populations, outcomes, and intervention design are appropriate,” experts say.
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Racial and Ethnic Inequities in the Quality of Pediatric Care in the USA: A Review of Quantitative Evidence (The Lancet Child & Adolescent Health)

While reviewing studies published between January 1, 2017 and July 31, 2022, researchers found that the literature reveals widespread patterns of inequitable treatment across pediatric specialties, including neonatology, primary care, emergency medicine, inpatient and critical care, surgery, developmental disabilities, mental healthcare, endocrinology, and palliative care—indicating that children from minority groups received poorer healthcare services relative to non-Hispanic White children.
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US Government Sets Rule Meant to Speed Up Insurance Approvals (Reuters)

US President Joe Biden’s administration has finalized a rule requiring health insurers to set time targets for the prior authorization process for patients seeking approval for medical services under insurance plans backed by Medicare and Medicaid. The rule will begin primarily in 2026.
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Population Confidence in the Health System in 15 Countries: Results From the First Round of the People’s Voice Survey (The Lancet Global Health)

Using data from the People’s Voice Survey—a novel population survey conducted in 15 low-, middle-, and high-income countries—researchers found fewer than half of respondents were health secure and reported being somewhat or very confident that they could get and afford good-quality care if very sick. The lowest support was in Peru, the United Kingdom, and Greece.
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Physicians’ Perspectives on FDA Regulation of Drugs and Medical Devices: A National Survey (Health Affairs)

Researchers say the findings suggest that physicians commonly lack familiarity with drug and medical device regulatory practices and are under the impression that the data supporting the US Food and Drug Administration’s drug and high-risk device approvals are more rigorous than they often are. Physicians would value more rigorous premarket evidence, as well as regulatory action for drugs and devices that do not demonstrate safety and effectiveness in the postmarket setting.
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The WHO and Drug Regulators Want to Reformulate the Flu Vaccine. It’s Easier Said Than Done (STAT News)

In fall 2023, the World Health Organization and some national drug regulators urged that manufacturers remove the component known as B/Yamagata from flu vaccines as quickly as possible, citing the fact that this lineage of flu B viruses appears to have been snuffed out during the COVID-19 pandemic. However, the International Federation of Pharmaceutical Manufacturers and Associations, an organization that represents vaccine manufacturers and other pharmaceutical entities, is calling for a longer lead time for the shift, saying it will take flu vaccine makers until the 2025-2026 Northern Hemisphere cycle to be able to make the change across the board.
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The Remote Healthcare Revolution: An Investigation Into HCPs’ Perceptions of the Evolving Digital Landscape— Part 1: Telemedicine (IQVIA)

Covadonga Fernández del Pozo Bielza (Prod OpnsAnalytics Solutions), Carolina Ricarte, (Product Offering Development), and Tom Woods, (EMEA Thought Leadership) say in interviewing 1600 physicians from 11 different countries, IQVIA found that face-to-face consultations remain the dominant channel across all countries, and it is expected that the proportion will remain relatively stable in the next 6 months to come. Additionally, while Italy and the United Kingdom have the highest remote consultation shares, Japan had the lowest.
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E&C Investigation Uncovers Earliest Known SARS-CoV-2 Sequence Released Outside of China (House Energy & Commerce Committee)

The House Energy and Commerce claims that that a SARS-CoV-2 sequence was submitted to GenBank, the National Institutes of Health’s genetic sequence database operated by the National Center for Biotechnology Information, on December 28, 2019—2 weeks before the Chinese Center for Disease Control and Prevention (China CDC) first released the virus’s sequence. “The existence of a SARS-CoV-2 sequence days before the Chinese Communist Party (CCP) acknowledged an outbreak, and more than 2 weeks before the China CDC release their sequence, calls into question how early the CCP knew about the virus and how long they withheld this information from the world, resulting in more deaths and wasting critical time to develop vaccines and treatments.”
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Testosterone Treatment and Fractures in Men with Hypogonadism (NEJM)

Researchers found that among middle-aged and older men with hypogonadism, testosterone treatment did not result in a lower incidence of clinical fracture than placebo. Additionally, the fracture incidence was numerically higher among men who received testosterone than among those who received placebo.
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Chinese Hospital Finds New Genetic Sequence for Rare Blood Type P During Routine Tests (South China Morning Post)

Modern Express Post reported that the previously unknown nucleotide sequence in a person with the rare blood type p, a subtype of the P blood group, was found during routine blood tests last year at a hospital in Taizhou, Jiangsu province. The genetic sequence has been submitted to the GenBank sequence database in the United States, which has said the nucleotide sequence present in the sample had not been detected previously anywhere in the world.
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