Industry Sponsorship Research Articles

Illuminating the landscape of high-level clinical trial opportunities in the All of Us Research Program.

With its size and diversity, the All of Us Research Program has the potential to power and improve representation in clinical trials through ancillary studies like Nutrition for Precision Health. We sought to characterize high-level trial opportunities for the diverse participants and sponsors of future trial investment. We matched All of Us participants with available trials on ClinicalTrials.gov based on medical conditions, age, sex, and geographic location. Based on the number of matched trials, we (1) developed the Trial Opportunities Compass (TOC) to help sponsors assess trial investment portfolios, (2) characterized the landscape of trial opportunities in a phenome-wide association study (PheWAS), and (3) assessed the relationship between trial opportunities and social determinants of health (SDoH) to identify potential barriers to trial participation. Our study included 181529 All of Us participants and 18634 trials. The TOC identified opportunities for portfolio investment and gaps in currently available trials across federal, industrial, and academic sponsors. PheWAS results revealed an emphasis on mental disorder-related trials, with anxiety disorder having the highest adjusted increase in the number of matched trials (59% [95% CI, 57-62]; P < 1e-300). Participants from certain communities underrepresented in biomedical research, including self-reported racial and ethnic minorities, had more matched trials after adjusting for other factors. Living in a nonmetropolitan area was associated with up to 13.1 times fewer matched trials. All of Us data are a valuable resource for identifying trial opportunities to inform trial portfolio planning. Characterizing these opportunities with consideration for SDoH can provide guidance on prioritizing the most pressing barriers to trial participation.

Industry Sponsorship Bias in Collagenase Clinical Trials for Dupuytren Disease: A Meta-analysis.

Collagenase clostridium histolyticum (collagenase) was introduced in 2010 creating a nonoperative treatment option for Dupuytren disease with promising results in sponsored clinical trials. A meta-analysis was performed to investigate industry sponsorship bias. A systematic review of collagenase treatment of Dupuytren contracture was conducted. Articles containing mesh terms including "microbial collagenase" and "Dupuytren's contracture" were searched and limited to only clinical trials with similar protocols for inclusion. Meta-analysis of treatment endpoints of correction of contracture to 0-5 degrees after first and last injection was conducted comparing sponsored versus nonsponsored studies. Sixteen of the 29 identified articles met criteria for inclusion. Nonsponsored studies reported a significantly higher rate of meeting the primary treatment endpoint compared to sponsored studies after single injection for all joints (69.6% vs 56% P < 0.01), metacarpophalangeal joint (96% vs 64% P < 0.01), and proximal interphalangeal joint (67% vs 36% P = 0.011). The correction in contracture rates was similar between groups with studies evaluating more than one injection. Nonsponsored studies published higher success rates in meeting the primary endpoint of full correction after single injection than sponsored studies; however, similar results with multiple injections. This study demonstrated that sponsored studies of collagenase produced highly powered studies that may be reliably depended on for evidence-based clinical application.

529 Implementation of a Clinical Research Feasibility Program at an Academic Medical Center

OBJECTIVES/GOALS: The objectives are 1) to describe the creation and implementation of a Clinical Research Feasibility Program at the University of Miami Miller School of Medicine (UMMSOM), and 2) to share early findings demonstrating its effectiveness in improving research operations which may be helpful for other academic medical centers. METHODS/STUDY POPULATION: Many clinical trials are closed prematurely because of low accrual or not being able to meet the target enrollment. The Miami CTSI and UMMSOM Executive Dean for Research office collaborated to establish the Research Feasibility Committee (RFC) focusing on clinical trial selection with upfront feasibility and recruitment planning. Program implementation included: 1) selecting faculty with successful clinical trial track records as committee members; 2) developing processes, tools, and governance; 3) feasibility pilot testing; and 4) feasibility program roll out and refinement. The feasibility review process starts with the PI/Designee completing a REDCap study intake form, followed by an administrative review to ensure completeness of the form. The RFC chair assigns reviewers for the studies. RESULTS/ANTICIPATED RESULTS: The RFC went live on September 1, 2022 reviewing industry sponsor clinical research studies. The RFC conducts a systematic feasibility assessment of the study protocol, operational requirements, enrollment barriers, institutional resources, and study budget (if available) for all applicable research studies prior to IRB submission and contract negotiation at the UMMSOM. To date, the RFC has received over 270 submissions. Based on feedback from users, the committee has made changes to improve the comprehension of questions and added questions to ensure capturing of critical information to assess study feasibility. Initial metrics suggest simply implementing the review process has decreased the number of clinical trial submissions: average number of studies per quarter was 41 pre-RFC vs 24 post RFC. DISCUSSION/SIGNIFICANCE: The development and implementation of the RFC involved many stakeholders from the research enterprise. Clear and frequent communication to the research community was a key factor in the program’s success. The next phase is assessing the impact of the RFC, such as preserving vital resources for trials more likely to be successful.

Multidisciplinary Capstone Senior Design Projects: A Comparative Analysis of Industry–Sponsored and Faculty–Sponsored Projects Using Comprehensive Performance Metrics

Engineering education has continually evolved to embrace Project–Based Learning (PBL), a dynamic classroom approach emphasizing learning through engagement in real–world projects. The study conducts a comparative analysis of multidisciplinary Capstone Senior Design Projects across Electrical Engineering, Mechanical Engineering, and Computer Science at Texas A&amp;M University at Texarkana. The research emphasizes understanding the dynamics of student collaboration within these disciplines and scrutinizes the impact of industry and faculty sponsorship on these projects. The methodology involves a comprehensive comparative analysis, employing diverse performance metrics to evaluate the effectiveness of different sponsorship models. This approach aims to uncover the influence of these models on project outcomes and students’ educational experiences. The results reveal notable differences between industry–sponsored and faculty–sponsored projects. Industry sponsorship leads to higher performance in overall project execution and professional skills development. In contrast, faculty–sponsored projects are more effective in nurturing teamwork and communication abilities among students. The findings suggest that each sponsorship type presents unique benefits and challenges. Industry–sponsored projects provide valuable hands–on problem–solving experience, though they may suffer from inconsistencies in mentorship and varying expectations. Faculty–sponsored projects offer a more stable and consistent educational environment but might lag slightly in performance metrics. Integrating elements from both sponsorship models could provide students with a more balanced and enriching learning experience.

Alcohol industry-sponsored music festivals, alcohol marketing and drinking practices among young Nigerians: Implications for policy

IntroductionThe global alcohol industry sponsors social/music events targeting young people; however, existing literature focuses on Westernised contexts. Given the decline in young people's drinking in many Western countries, it appears that multinational alcohol companies are importing the strategies they have used in high-income countries to the Global South countries like Nigeria to recoup profits. This study aims to examine the Guinness Show- a free one-month annual music festival, alcohol marketing at the festival and the extent to which the event encourages diverse drinking practices among its attendees. MethodsWe observed the music festival before collecting data through 53 interviews and 3 focus groups (N = 26). Data were analysed to generate themes with the aid of NVivo 12 software. FindingsOver 6000 participants attend the Guinness Show daily, and participants gave detailed descriptions of the music festival, alcohol marketing activities that occur in it and the drinking practices of attendees, indicating that they were highly knowledgeable of the event. The Guinness Show attracts famous music artistes and other entertainers. Therefore, young people attend to see them perform free of charge. However, diverse alcohol promotions (e.g., quantity deals, low prices, giveaways) that happen daily, the strategic use of young women as ‘beer promoters’, and the pleasure the event induces by fusing music/entertainment into alcogenic environments, encourage drinking and drunkenness. All the attendees drank alcohol, and some engaged in impulse buying, while many consumed excessively due to promotions (e.g., buy-two-get-one free), which facilitated intoxication and the loss of control. ConclusionsGuinness Nigeria organises the event for strategic brand communication, generating brand capital, and encouraging alcohol purchases and consumption among young people. Policymakers should reconsider self-regulation and implement national alcohol control policies and other public health interventions to restrain the alcohol industry from sponsoring such events.

Phase IV Drug Trials With a Canadian Site: A Comparison of Industry and Non-Industry-Funded Trials.

Recent regulatory reforms have favored expedited drug marketing and increased reliance on Phase IV clinical trials for safety and efficacy assurance. This study, utilizing ClinicalTrials.gov, assesses the characteristics of Phase IV trials, with at least one site in Canada, examing those funded by industry sponsors and those lacking industry funding. Additionally, it compares the publication status of industry-funded and non-industry-funded trials through a manual review of the medical literature. Between 2000 and 2022, 864 Phase IV trials were completed, with 480 (55.6%) receiving industry funding and 384 (44.4%) funded solely by non-industry sources. Industry-funded clinical trials were larger (mean 204 enrollees versus 70), more likely to be international (57.7% versus 9.6%) and reported results more promptly (1.21 years after completion versus 1.85 years), yet both types shared similar design, outcomes, and completion time. Publication rates were 81.8% for industry-funded and 65.8% for non-industry-funded trials. The ClinicalTrials.gov registry displayed 48 inaccuracies in publication associations, raising concerns about its accuracy. Our findings underscore the existing institutional limitations in ensuring comprehensive reporting and publication of Phase IV trial results funded by both industry and non-industry sources.

Characteristics of contemporary atrial fibrillation clinical trials and their association with industry sponsorship

BackgroundIndustry sponsorship is an important source of funding for atrial fibrillation (AF) clinical trials, the implications of which have not been analyzed. ObjectiveThe purpose of this study was to determine the characteristics of contemporary AF clinical trials and to evaluate their association with funding source. MethodsWe systematically assessed all completed AF trials registered in the ClinicalTrials.gov database between conception to October 31, 2023, and extracted publicly available information including funding source, trial size, demographic distribution, intervention, location, and publication status. Trial characteristics were compared using the Wilcoxon rank-sum test and Fisher exact test for continuous and categorical variables, respectively. ResultsOf the 253 clinical trials assessed, 171 (68%) reported industry funding. Industry funding was associated with a greater median number of patients enrolled (172 vs 80; P <.001), publication rate (56.7% vs 42.7%; P = .04), probability of being product-focused (48.0% vs 24.4%; P <.001), and multicontinental recruitment location (25.2% vs 2.4%; P <.001) when compared to nonindustry-funded trials. However, industry funding was not associated with a significant difference in median impact factor (7.7 vs 7.7; P = .723). The overall proportion of industry-funded trials did not change over time (P = 1). ConclusionIndustry-funded clinical trials in AF often are larger, more frequently published, multicontinental, and product-focused. Industry funding was found to be associated with significant differences in study enrollment and publication metrics.

A single-center real-world review of 10 kHz high-frequency spinal cord stimulation outcomes for treatment of chronic pain

ObjectiveTo compare pragmatic real-world 10-kHz high-frequency spinal cord stimulation (HF-SCS) outcomes at a single academic center to the industry-sponsored SENZA-RCT and Stauss et al. study. MethodsThis single-center retrospective study included patients with refractory back or limb pain trialed and/or permanently implanted with the Nevro HF-SCS system from 2016 to 2021. Demographic and outcome data were obtained from the electronic medical record (EMR) and real-world global database maintained by Nevro Corp. Data obtained from the global database were confirmed using the EMR. Main outcome measures included positive responder status (≥50% patient-reported percentage pain reduction (PRPPR)), improvement in function, improvement in sleep, and reduction in pain medication usage. Comparison groups included patient outcomes from the SENZA-RCT and Stauss et al. study. ResultsPatients (N = 147) trialed with HF-SCS were reviewed, with data available for 137. Positive trialed patient responder rate (≥50% PRPPR) was 77% (106/137, 95CI 70–84%) vs. 87% (1393/1607, 95CI 85–89%) Stauss et al. vs. 93% (90/97, 95CI 88–98%) SENZA-RCT HF-SCS. At the last available follow-up, positive implanted patient responder rate was 73% (58/80, 95CI 63–82%) vs. 78% (254/326, 95CI 73–82%) Stauss et al. vs. 79% (71/90, 95CI 70–87%) SENZA-RCT HF-SCS. Sixty-seven percent (59/88, 95CI 57–77%) reported improved function vs. 72% (787/1088, 95CI 70–75%) Stauss et al.; 45% (31/69, 95CI 33–57%) reported improved sleep vs. 68% (693/1020, 95CI 65–71%) Stauss et al. and 16% (9/56, 95CI 6–26%) reported decrease in medication use vs. 32% (342/1070, 95CI 29–35%) Stauss et al. ConclusionPatient responder rates in this retrospective pragmatic real-world study of HF-SCS are consistent with previous industry-sponsored studies. However, improvements in quality-of-life measures and reduction in medication usage were not as robust as reported in industry-sponsored studies. The findings of this non-industry-sponsored, independent study of HF-SCS complement those of previously published studies by reporting patient outcomes collected in the absence of industry sponsorship.

Cost-benefit ratio of modern medical education using micro-costing: amodel calculation using the example of an innovative breast brachytherapy workshop.

Radiation oncology is an essential component of therapeutic oncology and necessitates well-trained personnel. Multicatheter brachytherapy (MCBT) is one radiotherapeutic option for early-stage breast cancer treatment. However, specialized hands-on training for MCBT is not currently included in the curriculum for residents. Arecently developed hands-on brachytherapy workshop has demonstrated promising results in enhancing knowledge and practical skills. Nevertheless, these simulation-based teaching formats necessitate more time and financial resources. Our analyses include computational models for the implementation and delivery of this workshop and can serve as abasis for similar educational initiatives. This study aimed to assess the cost-effectiveness of apreviously developed and evaluated breast brachytherapy simulation workshop. Using amicro-costing approach, we estimated costs at adetailed level by considering supplies, soft- and hardware, and personnel time for each task. This method also allows for acomprehensive evaluation of the costs associated with implementing new medical techniques. The workshop costs were divided into two categories: development and workshop execution. The cost analysis was conducted on aper-participant basis, and the impact on knowledge improvement was measured using aquestionnaire. The total workshop costs were determined by considering the initial workshop setup expenses including the development and conceptualization of the course with all involved collaborators, as well as the costs incurred for each individual course. The workshop was found to be financially efficient, with aper-participant cost of € 39, considering the industrial sponsorship provided for brachytherapy equipment. In addition, we assessed the workshop's efficacy by analyzing participant feedback using Likert scale evaluations. The findings indicated anotable enhancement in both theoretical and practical skills among the participants. Moreover, the cost-to-benefit ratio (CBFR) analysis demonstrated aCBFR of € 13.53 for each Likert point increment. The hands-on brachytherapy workshop proved to be avaluable and approximately cost-effective educational program, leading to asignificant enhancement in the knowledge and skills of the participants. Without the support of industrial sponsorship, the costs would have been unattainable.

Support for dermatological research in Sub-Saharan Africa: insights from African hair and skin research programs.

The structure and physiology of skin and hair in people of African ancestry are different from other ethnic categories and studies from other continents cannot necessarily be extrapolated to Sub-Saharan Africa (SSA) due to the differences in genetics, lifestyle, climate, cultures, and hair and skin care practices. The aim of this report is to highlight the recent advances in local skin and hair research in SSA from a grant program. African Hair and Skin Research Grants from an industrial sponsor were awarded between 2013 and 2022 on five main topics: acne, hair and scalp, keloid scars, atopic dermatitis, and air pollution. A literature search in Scopus identified publications on these topics in African or black skin in SSA and worldwide to provide insight into the impact of the program. The number of publications from around the world on the skin and hair of people of African ancestry has increased significantly over the past 30 years on all five topics, especially as a result studies conducted in the United States. Fewer studies have been conducted in SSA but there has been an increasing number of publications over the past 10 years, especially from South Africa. Scientific and clinical partnerships between the industry, academia, and public healthcare sectors have contributed to a steady increase in hair and skin publications from SSA, which may be useful for the development of tailored products and public educational campaigns to raise awareness of the risks of using inappropriate products.

Industry Sponsorship in Dentistry: An Ethics Scoping Review

Evidence to guide dentistry on conflict of interest (COI) and professional-industry relationships is limited. To determine the breadth of literature regarding ethics in dentistry and COI relating to sponsorship. A scoping review following the PRISMA extension was performed. Medline/PubMed and Cochrane Library databases were used to identify peer-reviewed sources, published 2013-2023. Titles, abstracts, and full-text reviews were conducted by two independent reviewers. Disagreements were resolved by consensus. The remaining studies underwent critical appraisal. Key findings were extracted and analyzed. Adjusted for critical appraisal thresholds, we evaluated a total of (n=9) studies associated with dentistry, COI, and sponsorship (industry and non-profit research funding). The majority of evidence demonstrated a significant correlation with disclosure of COI and professional ethical conflict. More than 32% of publications demonstrated no clear disclosure or failed to report COI. Sponsored studies demonstrated significantly greater scrutiny of disclosure practices, whereas industry/dentist-reported payments were prevalent but varied widely (19% to 62%). Regardless of funding or influence, dental professionals are likely to disclose industry conflicts when presented with policies to guide transparency, thus strengthening patient trust and professional code of ethics.

Participant Diversity in United States Randomized Controlled Trials of Antibacterials for Staphylococcus aureus Infections, 2000-2021.

Equitable representation of members from historically marginalized groups is important in clinical trials, which inform standards of care. The goal of this study was to characterize the demographics and proportional subgroup reporting and representation of participants enrolled in randomized controlled trials (RCTs) of antibacterials used to treat Staphylococcus aureus infections. We examined randomized controlled registrational and strategy trials published from 2000-2021 to determine the sex, race, and ethnicity of participants. Participation to incidence ratios (PIRs) were calculated by dividing the percentage of study participants in each demographic group by the percentage of the disease population in each group. Underrepresentation was defined as a PIR <0.8. Of the 87 included studies, 82 (94.2%) reported participant sex; 69 (79.3%) reported participant race; and 20 (23.0%) included ethnicity data. Only 17 (19.5%) studies enrolled American Indian/Alaskan Native participants. Median PIRs indicated that Asian and Black participants were underrepresented in RCTs compared with the incidence of methicillin-resistant S. aureus (MRSA) infections in these subgroups. Underrepresentation of Black participants was associated with a larger study size, international sites, industry sponsorship, and Phase 2/3 trials compared with Phase 4 trials (P<0.05 for each). Black participants had over 4 times the odds of being underrepresented in Phase 2/3 trials compared with Phase 4 trials (OR 4.57; 95% CI 1.14-18.3). Standardized reporting methods for race and ethnicity and efforts to increase recruitment of marginalized groups would help ensure equity, rigor, and generalizability in RCTs of antibacterial agents and reduce health inequities.

Cancer researchers’ experiences with and perceptions of research data sharing: Results of a cross-sectional survey

ABSTRACT Background: Despite wide recognition of the benefits of sharing research data, public availability rates have not increased substantially in oncology or medicine more broadly over the last decade. Methods: We surveyed 285 cancer researchers to determine their prior experience with sharing data and views on known drivers and inhibitors. Results: We found that 45% of respondents had shared some data from their most recent empirical publication, with respondents who typically studied non-human research participants, or routinely worked with human genomic data, more likely to share than those who did not. A third of respondents added that they had previously shared data privately, with 74% indicating that doing so had also led to authorship opportunities or future collaborations for them. Journal and funder policies were reported to be the biggest general drivers toward sharing, whereas commercial interests, agreements with industrial sponsors and institutional policies were the biggest prohibitors. We show that researchers’ decisions about whether to share data are also likely to be influenced by participants’ desires. Conclusions: Our survey suggests that increased promotion and support by research institutions, alongside greater championing of data sharing by journals and funders, may motivate more researchers in oncology to share their data.

Imagining Otherwise: Conceptualising Sustainability in an Era of Extractivism Through an Agonistic Feminist Lens: A Response to Gendron (2024)

ABSTRACT This article explores the tension between sustainability, accounting and governance from an agonistic pluralist perspective adopting feminism as a methodology. Inspired by a commentary by Gendron (2024, in this issue) on the trustworthiness of science in the light of industry sponsorship of academic institutions, this article questions more deeply the acceptance of an extractive mindset which weaves into the organising of society as it influences what topics to prioritise and what to leave out of the mainstream narrative. The article draws in particular from the work of Mouffe (2000, 2013; see also Laclau and Mouffe, 2014) and Davis (2016). These studies, alongside other work, in particular by Black and Indigenous scholars, seeking to dismantle the oppressive bodies of capitalism, colonialism, racism, and patriarchy, have inspired my own reflections for this article. While these are all complex issues in and of themselves, which need further exploration beyond the rich body of existing literature, discussing them together and in relation to sustainability provides an opportunity to realise the equivalences in the struggles and encourage the formation of solidarity.

Sponsorship of Clinical Trials Related to the Shoulder and Elbow: Trends Over Time and Comparative Analysis of Trial Characteristics by Sponsorship Type.

Sponsorship trends have not been specifically evaluated for shoulder and elbow clinical trials, nor have trial characteristics been compared among shoulder and elbow trials sponsored by institutions, industries, and federal agencies. ClinicalTrials.gov was queried for clinical trials using the terms 'shoulder' and 'elbow.' Trial characteristics were abstracted, including start year, intervention type, phase, randomization, and blinding. Univariate and multivariate analyses were performed to determine associations between sponsorship type and other trial characteristics. In total, 4,945 shoulder clinical trials and 1,517 elbow clinical trials were identified, of which 26 shoulder clinical trials and seven elbow clinical trials were excluded due to incomplete data. From 2000 to 2022, the number of shoulder and elbow trials initiated annually markedly increased driven by an increase in the number of institutional trials. Relative to trials with institutional sponsorship, industry sponsorship was independently associated with different intervention types, phase of study, lack of randomization, and blinding. From 2000 to 2022, the number of shoulder and elbow clinical trials initiated annually markedly increased, driven by an increase in institutionally sponsored trials. For clinical trials related to the shoulder, design characteristics were found to differ based on study sponsorship type. This suggests that the design characteristics of shoulder-related clinical trials are shifting over time.

Management of evidence and conflict of interest in guidelines on early childhood allergy prevention and child nutrition: study protocol of a systematic synthesis of guidelines and explorative network analysis.

With the rising prevalence of allergic diseases in children, prevention of childhood allergies becomes an important public health issue. Recently, a paradigm shift is taking place in the approach to preventing allergies, and clinical practice guidelines (CPG) and food-based dietary guidelines (FBDG) play an important role in providing practitioners with the latest evidence and reliable guidance. However, concern about the methodological quality of the development of FBDGs and CPGs, including limitations in the systematic reviews, lack of transparency and unmanaged conflicts of interest (COI), reduce the trust in these guidelines. We aim to synthesize the available guidance on early childhood allergy prevention (ECAP) through a systematic search for national and international CPGs and FBDGs concerning ECAP and child nutrition (CN) and to assess the quality of the guidelines and management of COI. Additionally, we will analyse the content and the evidence base of the recommendation statements. We aim to quantify the COI in guideline panellists and explore possible associations between COI and recommendations. Through a social network analysis, we expect to elucidate ties between panellists, researchers, institutions, industry and other sponsors. Guidelines are an important tool to inform healthcare practitioners with the newest evidence, but quality and reliability have to be high. This study will help identify potential for further improvement in the development of guidelines and the management of COI. If the social network analysis proves feasible and reveals more information on COI in comparison to disclosed COI from the previous analyses, the methodology can be developed further to identify undisclosed COIs in panelists. This research does not require ethical approval because no human subjects are involved. Results will be published in international peer-reviewed open access journals and via presentations at scientific conferences.

The Safety of Contraction of Subcutaneous Tissue Following Liposuction Procedures

Abstract   This paper examines the practice of using a helium plasma radiofrequency (RF) device for contracting subcutaneous soft tissue following liposuction in all body areas. A review of the data from 6 industry-sponsor-initiated retrospective studies was performed, wherein 483 real-world patients underwent liposuction followed by contraction of the subcutaneous soft tissue with the helium plasma RF system. These data were evaluated to determine if any new or increased risks were introduced compared to the risks of liposuction alone. The totality of the real-world data demonstrates there are no new or increased risks for helium plasma RF procedures following liposuction compared to liposuction alone. These data support the safety of helium plasma RF for subcutaneous soft-tissue contraction following liposuction. There are currently no alternative therapies specifically cleared by the FDA that can claim use following liposuction for the purpose of contracting the subcutaneous soft tissue. Level of Evidence: 3

ScreenPlus: A comprehensive, multi-disorder newborn screening program

The increasing availability of novel therapies highlights the importance of screening newborns for rare genetic disorders so that they may benefit from early therapy, when it is most likely to be effective. Pilot newborn screening (NBS) studies are a way to gather objective evidence about the feasibility and utility of screening, the accuracy of screening assays, and the incidence of disease. They are also an optimal way to evaluate the complex ethical, legal and social implications (ELSI) that accompany NBS expansion for disorders. ScreenPlus is a consented pilot NBS program that aims to enroll over 100,000 infants across New York City. The initial ScreenPlus panel includes 14 disorders and uses an analyte-based, multi-tiered screening platform in an effort to enhance screening accuracy. Infants who receive an abnormal result are referred to a ScreenPlus provider for confirmatory testing, management, and therapy as needed, along with longitudinal capture of outcome data. Participation in ScreenPlus requires parental consent, which is obtained in active and passive manners. Patient-facing documents are translated into the ten most common languages spoken at our nine pilot hospitals, all of which serve diverse communities. At the time of consent, parents are invited to receive a series of online surveys to capture their opinions about specific ELSI-related topics, such as NBS policy, residual dried blood spot retention, and the types of disorders that should be on NBS panels. ScreenPlus has developed a stakeholder-based, collective funding model that includes federal support in addition to funding from 14 advocacy and industry sponsors, all of which have a particular interest in NBS for at least one of the ScreenPlus disorders. Taken together, ScreenPlus is a model, multi-sponsored pilot NBS program that will provide critical data about NBS for a broad panel of disorders, while gathering key stakeholder opinions to help guide ethically sensitive decision-making about NBS expansion.

Trabecular Procedures Combined with Cataract Surgery for Open-Angle Glaucoma: A Report by the American Academy of Ophthalmology

To determine the intraocular pressure (IOP) reduction of various trabecular procedures (a form of minimally invasive glaucoma surgery [MIGS]) combined with cataract surgery compared with cataract surgery alone, to compare the safety of the various trabecular procedures, and to highlight patient characteristics that may favor one trabecular procedure over another. A search of English-language peer-reviewed literature in the PubMed database was initially conducted in February 2021 and updated in April 2023. This yielded 279 articles. Twenty studies met initial inclusion and exclusion criteria and were assessed for quality by the panel methodologist. Of these, 10 were rated level I, 3 were rated level II, and 7 were rated level III. Only the 10 level I randomized controlled trials (RCTs) were included in this assessment, and all were subject to potential industry-sponsorship bias. The current analysis focuses on the amount of IOP reduction (in studies that involved medication washout) and on IOP reduction with concurrent medication reduction (in studies that did not involve medication washout). Based on studies that performed a medication washout, adding a trabecular procedure to cataract surgery provided an additional 1.6 to 2.3 mmHg IOP reduction in subjects with hypertensive, mild to moderate open-angle glaucoma (OAG) at 2 years over cataract surgery alone, which itself provided approximately 5.4 to 7.6 mmHg IOP reduction. In other words, adding a trabecular procedure provided an additional 3.8% to 8.9% IOP reduction over cataract surgery alone, which itself provided 21% to 28% IOP reduction. There was no clear benefit of one trabecular procedure over another. Patient-specific considerations that can guide procedure selection include uveitis predisposition, bleeding risk, metal allergy, and narrowing of Schlemm's canal. There are no level I data on the efficacy of trabecular procedures in subjects with pretreatment IOP of 21 mmHg or less. Trabecular procedures combined with cataract surgery provide an additional mild IOP reduction over cataract surgery alone in hypertensive OAG subjects. Additional research should standardize outcome definitions, avoid industry sponsorship bias, and study the efficacy of these procedures in normotensive OAG. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Sponsorship of clinical trials related to the spine: Trends over time and comparative analysis of trial characteristics by sponsorship type

Clinical trials are crucial to advance products and procedures related to the spine. ClinicalTrials.gov is an internet-based registry and results database that catalogs trial characteristics, such as intervention types, phase, randomization, and blinding. Sponsorship trends have not been specifically evaluated for spine-related clinical trials, nor have trial characteristics been compared among spine-related trials sponsored by institutions, industries, and federal agencies. The purpose of this cross-sectional analysis of spine-related clinical trials was to characterize the types and trends of sponsorship for spine-related clinical trials, and compare trial characteristics among trials sponsored by institutions, industries, and federal agencies. ClinicalTrials.gov was queried for clinical trials started from the launch of ClinicalTrials.gov (February 29, 2000) through December 31, 2022, using the term "spine." Trial characteristics were abstracted, including start year, intervention type, phase, randomization, and blinding. Univariate and multivariate analyses were performed to determine associations between sponsorship type and other trial characteristics. A total of 4,484 clinical trials were identified, of which 78 trials were excluded due to incomplete reporting of trial registration data. From 2000 through 2022, the number of spine-related trials initiated annually markedly increased (from 21 to 453, representing an increase of 2,057%). This was predominantly driven by an increase in the number of institutionally sponsored trials. Relative to trials with institutional sponsorship, industry sponsorship was independently associated with different intervention types, phases of study, lack of randomization, and lack of blinding. Relative to trials with institutional sponsorship, federal sponsorship was independently associated with intervention type, and phase of study. From 2000 through 2022, the number of spine-related clinical trials initiated annually markedly increased, driven by an increase in institutionally sponsored trials. Specific trial characteristics were more or less likely for industrially or federally sponsored trials relative to institutionally sponsored trials suggesting the types of clinical trials are shifting over time.