Joseph Solomon Ross

Background: Randomized trials show substantial weight loss with semaglutide and tirzepatide under structured care, but little is known about whether patients in routine practice continue therapy, reach a maintenance dose, and have their weight measured. Objectives: To describe the first year after initiation of semaglutide or tirzepatide for obesity, including care patterns, maintenance-dose attainment, weight documentation, and total body weight loss (TBWL). Methods: This retrospective cohort study used Epic Cosmos, an electronic health record network of >350 US health systems, to identify adults with obesity and without diabetes who initiated injectable semaglutide or tirzepatide in 2024. Outcomes over 12 months included prescribing persistence, discontinuation, switching, add-on therapy, and reinitiation; attainment of Food and Drug Administration (FDA)-labeled maintenance doses; availability of follow-up weight; and TBWL across progressively restricted populations. Results: Among 743,153 adults (60.1% semaglutide; mean age, 48.5 years; 72.5% female), 12-month prescribing persistence was 29.9% for semaglutide and 35.9% for tirzepatide. FDA-labeled maintenance-dose attainment was 28.3% and 55.0%, respectively, and only 8.8% and 16.4% remained prescribing persistent at a maintenance dose with a recorded weight at 12 months. About half of initiators lacked a 12-month weight. Among all initiators, ≥5% TBWL was documented in 25.6% (semaglutide) and 30.4% (tirzepatide), rising to 51.9% and 61.9% among those with recorded weight, 66.1% and 79.5% among those also prescribing persistent, and 82.9% and 87.3% among those further at a maintenance dose. Conclusions: In routine practice, most patients initiating semaglutide or tirzepatide did not remain on therapy, reach a maintenance dose, and have weight documented through the first year. Documented weight loss was greatest among those completing each step of care, suggesting continuation, dose escalation, and monitoring as targets for improvement. CENTRAL ILLUSTRATION: Care Cascade and Weight-Loss Outcomes Among Semaglutide and Tirzepatide Initiators, Standardized to 100 Initiators. Numbers are per 100 initiators and were rounded so that categories at each step sum to the preceding step. At the 12-month dose step, prescribed dose was missing for 1 per 100 semaglutide initiators and <1 per 100 tirzepatide initiators.

Background: Implantable loop recorders (ILRs) provide continuous rhythm monitoring. Professional society guidelines and expert consensus statements recommend ILR use for patients with recurrent syncope and cryptogenic stroke, but recommendations are weaker for other indications. We assessed ILR use over time and concordance between indication and clinical guidance. Methods: We conducted a retrospective cohort study using Epic Cosmos data from 1/1/2020-12/31/2025. Among active patients with at least one of 13 diagnoses potentially eligible for ILR placement, we identified ILR placements and classified them by concordance with professional society guidance: concordant, possibly, or non-addressed. Annual incidence was estimated overall and by indication. We also described the proportion of patients who received longer-term (>7 days) rhythm monitoring in the year prior to placement. Results: Of 47,046,706 patients with diagnoses potentially eligible for ILR placement, 201,103 (0.4%) had an ILR placed. ILR placements increased from 3.08 ILRs per 100,000 patient-days in 2020 to 4.13 in 2025 (5.9% annual growth). The most common indications were cryptogenic stroke (28.6%) and atrial fibrillation without prior ablation (21.4%). Overall, 43.9% were guidance concordant, 28.5% possibly concordant, and 24.8% non-addressed. Relative annual growth in ILR placements per 100,000 patient-days was significant across all guidance categories: concordant (1.3%, 95% CI, 0.9%-1.7%), possibly concordant (5.5%, 95% CI, 5.0%-6.0%) and non-addressed (7.4%, 95% CI, 6.8%-8.0%). Among 125,631 outpatient placements, 50,181 (39.9%) had any prior long-term rhythm monitoring. Conclusion: ILR placements are uncommon but increasing, with faster annual growth for indications that may not be guidance concordant. More than half of patients lacked long-term rhythm monitoring prior to outpatient ILR placement. What is known: – Prior research through 2018 demonstrated that many ILRs were placed for indications not supported by professional society guidelines or expert consensus statements. – Implantable loop recorder (ILR) technology has advanced with longer battery life, easier implantation processes, and robust remote monitoring and reprogramming. What the Study Adds: – ILR use remains uncommon for patients with diagnoses potentially eligible for ILR placement. – Annual incidence of ILR placement is increasing, especially among patients with indications not addressed by professional society guidelines or expert consensus statements. – Most ILR placements occur without pre-implant rhythm monitoring.

Objective: To assess the number, timing, characteristics, and scholarly impact of secondary publications generated using individual participant level data (IPD) from a portfolio of clinical trials shared with external investigators through a data sharing platform. Design: Cross sectional study. Setting: Yale University Open Data Access (YODA) Project platform. Participants: Johnson & Johnson sponsored clinical trials listed on the YODA Project platform with IPD available for external sharing through 2021 and with a full length, peer reviewed publication (that is, primary publication) reporting primary endpoint results by the original trial investigators. Main outcome measures: Number, timing, research objectives, analysis type, and scholarly impact of secondary publications using IPD from these trials identified through Web of Science citation searches of primary publications through June 2025. Scholarly impact metrics included journal impact factor, annual citation count, and annual Altmetric Attention Score. Secondary publications were classified as internal (authored by at least one original trial investigator) or external. Results: Among 336 eligible trials, 265 (79%) had at least one associated secondary publication, totalling 1167 publications, of which 209 (17.9%) were external. Among external publications with a reported data access mechanism (n=190; 91%), most obtained access through data sharing platforms (n=161; 85%), primarily the YODA Project (n=157; 83%). Over time, the proportion of external publications increased steadily, exceeding 50% of all secondary publications by year 11 and thereafter. Compared with internal publications, external publications were more frequently pooled analyses (151/209 (72%) v 534/958 (55.7%); Pv 322/958 (33.6%); Pv 114/958 (11.9%); Pv 66/958 (6.9%); Pv 4.6 (2.9-10.2); P=0.002) and had higher annual Altmetric Attention Scores (median 2.1 (0.7-7.1) v 0.6 (0.3-2.3); Pv 3.4 (1.6-7.5); Pv 235/805 (29.2%); Pv 206/805 (25.6%); P<0.001). Conclusions: Most trials in this portfolio of clinical trials, for which IPD were available through a data sharing platform, generated secondary research by both original trial investigators and external investigators. External investigators most often accessed data through the data sharing platform, and their publications accounted for an increasingly larger proportion of secondary publications over time. These findings suggest that structured data sharing mechanisms may support additional secondary use of clinical trial data and further enhance the scientific value of clinical trials.

Background and ObjectivesRegulatory guidance has long emphasized clinically meaningful outcomes in Alzheimer disease (AD) drug trials. No contemporary review has examined the efficacy measures used...

Introduction: Precision oncology biomarker testing informs prognosis and guides treatment selection. These tests represent a growing component of cancer care costs. Methods: We conducted a cross-sectional study of US commercial payer-negotiated rates for biomarker tests for breast, colon, and non-small cell lung cancer, using Turquoise Health hospital pricing database. Outcomes included geographically adjusted payer-negotiated rates, within- and between-hospital price variation, and differences by payer, rurality, and hospital size, assessed using generalized linear models adjusted for multiple comparisons. Results: We identified 422 515 negotiated rates for 28 biomarker tests across 2142 hospitals. Median proportion of hospitals reporting payer-negotiated rates was 18.3% (interquartile range [IQR]:17.2%-18.8%) for panel-based and 30.3% (IQR:22.2%-37.8%) for non-panel-based tests; median negotiated rates per test were $3704 (IQR: $3096-$4129) and $301 (IQR: $157-$485), respectively. Negotiated rates varied within hospitals (median within-hospital ratios: panel-based tests, 1.5 [IQR:1.4-1.5]; non-panel-based tests, 1.6 [IQR: 1.5-1.7]) and between hospitals (median between-hospital ratios: panel-based tests, 5.5 [IQR: 5.5-5.6]; non-panel-based tests, 5.2 [IQR: 5.1-5.4]). Negotiated rates varied significantly by payer for all tests. Conclusion: Our findings revealed wide variation in commercial payer-negotiated rates for oncology biomarker tests, underscoring the need for pricing transparency and efforts to reduce price variation to support equitable, affordable cancer care.

The Yale University Open Data Access (YODA) Project, in partnership with Johnson & Johnson since 2014, is an academic-led initiative that promotes independent, transparent, and responsible sharing of clinical trial data. Over the past decade, the YODA Project has made individual participant-level data and supporting documentation from an increasing number of clinical trials available to investigators for independent studies. As of March 31, 2025, there were 482 clinical trials across 86 medical conditions and 49 products available for a median of 6.6 years (interquartile range, 5.0–9.0). A total of 485 data requests have been submitted, with nearly all requests approved (463, 95.5%) or under review (7, 1.4%), and investigators gained data access in a median of 82.5 days (52.0–133.0) from request submission. Among the 463 approved requests, 139 (30.0%) have thus far resulted in at least one peer-reviewed article, yielding 165 articles. The YODA Project experience demonstrates how a data sharing platform has supported a wide range of scientific inquiries and highlights the practical value of responsible data sharing in promoting transparency, building trust, and advancing clinical research.

Introduction: Global availability of novel therapeutics varies widely across countries and is strongly associated with national income. However, whether drug characteristics are associated with global approval and launch remains unclear. Methods: We conducted a cross-sectional study of therapeutics approved by the US Food and Drug Administration (FDA) between 2008 and 2019, examining global regulatory approval and market launch through February 2026 using data from Citeline Pharmaprojects. Results: Among 396 FDA-approved novel therapeutics, approval or launch of at least one therapeutic was identified in 119 countries outside the United States. Therapeutics were approved and launched in a median of 36 and 17 countries, respectively. In multivariable drug-level analyses, biologics and therapeutics developed by large sponsors were approved or launched in more countries, infectious disease therapeutics in fewer countries. Drug innovation status, orphan designation, unmet medical need, and safety risk were not associated with global approval or launch. At the country level, high-income level, regulatory maturity, larger populations, and greater healthcare resources were associated with more approvals and launches. Conclusion: Global approval and launch of FDA-approved novel therapeutics were associated more strongly with country-level characteristics than drug-level characteristics. Improving global access may require addressing both regulatory and commercial barriers to approval and launch.