Michelle M Mello’s research while affiliated with Stanford Medicine and other places

PURPOSE To examine trends over time in clinical trial diversity for oncology therapeutics, identify bright spot trials adequately representing Black or Latino patients, and examine their associations with trial characteristics. METHODS This retrospective cross-sectional study of trials supporting US Food and Drug Administration (FDA) oncology therapeutic approvals (2012-2021) compared proportions of enrolled women, older adults, and racial and ethnic minoritized patients with US patient populations with approved indications and US census data, exploring trends over time. We estimated the likelihood that an organization sponsoring a trial adequately representing Black patients also sponsored a trial adequately representing Latino patients, and vice versa, and examined associations of bright spot trials, trials adequately representing Black or Latino patients, with trial characteristics. RESULTS The FDA approved 111 oncology therapeutics (2012-2021) from 70 sponsors, on 121 trials enrolling 50,871 patients, of which 22,155 (44%) were women, 9,442 (19%) older adults (>64 years), 5,319 (9.6%) Asian, 1,353 (3%) Black, and 1,511 (3%) Latino. Zero trials adequately represented all patient demographics with no improvements for any group over the past 10 years ( P values >.05), and 80% adequately represented women, 44% older adults (>64 years), and 2% racial and ethnic minoritized patients. We identified 33 bright spot trials, the likelihood of which was associated with individual sponsors ( P < .0001), but not sponsor size ( P = .22), indication ( P = .20), or trial phase ( P = .32). There were no associations between a company sponsoring a trial adequately representing Black patients and that company also sponsoring a trial adequately representing Latino patients, or vice versa ( P values >0.05). CONCLUSION Diverse trial enrollment is inadequate, without improvement over time. There are bright spot trials that may merit study for factors contributing to their successful recruitment of representative patients.

Policy Points Many have urged academic institutions to rethink conflict of interest policies governing leaders’ outside activities, which pose not only individual conflicts for leaders themselves but institutional conflicts for their academic employers. Although the American Association of Medical Colleges and Association of American Universities have provided guidance on managing such conflicts, neither offer a structured approach for determining when and under what conditions it is appropriate for a leader to engage in specific outside activities. To address this gap, this article develops a decision‐making framework that institutional oversight bodies can use to assess the permissibility of academic leaders’ proposed outside activities.

This Viewpoint discusses prospects for populating the regulatory landscape for health and health care AI in the coming years.

This JAMA Forum discusses barriers to state public health efforts, the outlook for public health, and suggestions to help protect the public’s health in the coming years.

The inflationary rebate provisions of the Inflation Reduction Act (IRA) of 2022 require pharmaceutical manufacturers to pay money back to Medicare if they raise prices faster than the rate of inflation. Opportunities now exist for Congress and the states to extend inflationary rebates to commercial plans. We demonstrate the potential savings from applying inflationary rebates to prescriptions filled in commercial plans by simulating savings under several policy design options. We estimate that a policy mimicking the IRA's design could have saved as much as $8.1 billion in 2021 by imposing rebates on 1,100 drugs. To minimize the administrative burden of assessing inflationary rebates, Congress or states could restrict rebates to certain high-cost drugs and still garner substantial savings. For example, including only drugs costing more than$830 per month or ranked in the top 300 drugs by total spending could halve the number of rebate-eligible drugs yet capture 96 percent of estimated savings that could be available under a policy that mimics the IRA design ($7.7 billion). Restricting eligibility to the top 300 drugs by total spending could capture 85 percent of those potential savings ($6.9 billion), imposing rebates on just 194 drugs.

Background: Late career physicians (LCPs; physicians working beyond age 65 to 75 years) may be at higher risk for delivering unsafe care. To oversee LCPs, some health care organizations (HCOs) have adopted LCP policies requiring cognitive, physical, and practice performance screening assessments. Despite recent controversies, little is known about the content and implementation of such policies. Objective: To characterize key features of LCP policies and the perspectives of medical leaders responsible for policy development and implementation. Design: Mixed-methods study using content analysis and key informant interviews. Setting: 29 U.S. HCOs with LCP policies active in 2020. Participants: 21 purposively sampled interviewees in physician leadership roles at 18 HCOs. Measurements: Descriptive statistics of policy features and content analysis of interviews. Results: Although policies had many commonalities-mandatory universal screening at a trigger age around 70 years, a strategy of screening followed by in-depth assessment of positive results, and commitment to patient safety as the key motive-they varied substantially in the testing required, funding, processes after a positive screening result, and decision making around concerning results. Policies prioritized institutional discretion in interpreting and responding to test results; many lacked clear language about appeals or other procedural protections for physicians. Leaders were generally satisfied with policies but reported preemptive retirements as physicians approached the screening age and cautioned that substantial investment in cultivating physicians' buy-in was required for successful rollout. Limitations: Sampled policies and interviews may not be representative of all HCOs. The analysis excluded the experiences of HCOs that tried and failed to implement LCP screening. Conclusion: Policies about LCPs are considered successful by institutional leaders. Policy variations and early adopters' implementation experiences highlight opportunities to improve physician acceptance and program rigor. Primary funding source: The Greenwall Foundation.

This JAMA Forum discusses new regulatory requirements for antidiscrimination in artificial intelligence tools used in health care, the dark side of flexible enforcement by agencies, and ways to facilitate meaningful compliance.

This Viewpoint discusses several major rulings from the US Supreme Court’s 2023 to 2024 term and how these rulings may affect federal agencies’ ability to enact health policy.