Type Of Sponsorship Research Articles

Measuring the impact of COVID-19 pandemic on the activeness, efficiency and international collaboration of clinical trials

Abstract The disruption of clinical trials during the COVID-19 pandemic has been discussed widely. But no systemically study has quantitatively examined the multi-dimensional effect of COVID-19 on the clinical trials of non-COVID-19 diseases under a well-recognized disease classification system. By acquiring over 380,000 clinical trials from ClinicalTrials.gov and Dimensions, and automatically mapping trials with the WHO Global Health Estimates (GHE) cause category, this study explores the effect of COVID-19 on trials’ activeness, efficiency, and international collaboration. Beyond a global perspective, the granular comparative analysis using the USA, China, Japan, the UK as representative cases are conducted. Utilizing an interrupted time series model, we find that while aggregate number of trial registrations has remained relatively stable, there is a notable crowding-out effect for non-COVID-19 diseases, affecting both non-communicable and communicable diseases. Interestingly, despite heightened focus on COVID- 19 research, trial efficiency for other diseases remained largely unaffected. COVID-19 prompted increased global collaboration in clinical research. Through further categorization of sponsorship type and identification of digitized trials by text-mining analysis, we summarized and validated three potential factors to shed light on the observed effects of COVID-19 on clinical studies. Additionally, the valuable insights and essential lessons in managing unprecedented pandemics are discussed. Peer Review https://www.webofscience.com/api/gateway/wos/peer-review/10.1162/qss_a_00354

Quantifying Data-Driven Campaigning Across Sponsors and Platforms

Although modern data-driven campaigning (DDC) is not entirely new, scholars have typically relied on reports and interviews of practitioners to understand its use. However, the advent of public ad libraries from Meta and Google provides an opportunity to measure the scope and variation in DDC practice in advertising across different types of sponsors and within sponsors across platforms. Using textual and audiovisual processing, we create a database of ads from the 2022 US elections. These data allow us to create an index that quantifies the extent of DDC at the level of the sponsor and platform. This index takes into account both the number of unique creatives placed and the similarity across those creatives. In addition, we explore the impact of sponsor resources, the office being sought, and the competitiveness of the race on the measure of DDC sophistication. Ultimately, our research establishes a measurement strategy for DDC that can be applied across ad sponsors, campaigns, parties, and even countries. Understanding the extent of DDC is vital for policy discussions surrounding the regulation of microtargeting and data privacy.

Detrimental Industries' Sponsorship in Football Clubs Across Ten Major Leagues from 2000-2022: A Retrospective Study.

Sponsorship of football teams by detrimental industries may negatively impact fans' dietary and behavioral choices. The study aimed to determine the proportion of sponsors on the jerseys of teams in the top ten football leagues that comprise companies producing alcohol or unhealthy food, or engaging in gambling. We conducted a retrospective study, incorporating data from first-division football teams in 10 countries (Argentina, Brazil, England, France, Germany, Italy, Poland, the Netherlands, Spain, and the United States) playing from 2000-2022. Data were collected on the primary sponsors displayed on team jerseys and categorized into alcohol, unhealthy food (defined as producers of ultra-processed food according to the NOVA classification), gambling, or other, based on the nature of the products or services offered by the sponsors. We performed descriptive statistical analyses and multivariate linear regression analyses. A total of 4452 sponsorship records were analyzed. The majority were classified as "other" (81.8%), followed by gambling (6.9%), alcohol (2.6%), and unhealthy food (2.6%). We did not identify any sponsor representing the tobacco industry. The prevalence of gambling sponsors surged from 1.7% in 2000 to 16.3% in 2022. Conversely, alcohol-related sponsorships dwindled from 6.2% in 2000 to 1.0% in 2022. In the multivariate linear regression model, these trends were statistically significant. The alcohol industry remained visible in the Spanish league. A significant proportion of sponsorships on the jerseys of top football teams across the world represents alcohol, ultra-processed food, or the gambling industry. Trends in the types of sponsors on the jerseys of leading football clubs across the Western world are diverse. Particularly concerning is the recent increase in the percentage of clubs sponsored by the gambling industry. To limit the detrimental effects of the promotion of unhealthy products, novel policies should be considered.

Uptake of health economic evaluations alongside clinical trials in Australia: an observational study.

Australia's clinical trials sector is highly productive with continued sector investment needed to enhance research impact. Generating economic evidence alongside trials has the potential to facilitate the implementation of trial results into practice. Ascertaining the use of health economic evaluations alongside clinical trials can assist in determining whether clinical trials fully realize and operationalize their potential to change policy and practice. The aims of this study were to ascertain the uptake of health economic evaluations alongside Australian-led clinical trials and explore associations between uptake and trial characteristics. This observational study comprised a descriptive analysis of clinical trials registries, a cross-sectional survey of Australian Clinical Trials Alliance (ACTA) networks, and a subgroup analysis of completed acute care trials. Descriptive analyses of trial registrations were conducted, with logistic regressions used to identify predictors of proposing and subsequently publishing a health economic evaluation alongside acute care trials. Few randomized Australian-led clinical trials (11% of 9251) and ACTA network trials (43% of 227) proposed a health economic evaluation. In the subgroup analysis, 22% of the 324 acute care trials and 53% of the 38 ACTA network acute care trials proposed a health economic evaluation. Acute care trials funded by government bodies were significantly more likely to propose and publish a health economic evaluation than those funded by hospitals, universities, and other funders, after adjusting for phase, registration year, primary sponsor type, and comparator. Current uptake of health economic evaluations alongside Australian-led clinical trials is low, with uptake higher among the subset of ACTA network trials. This is despite economic evidence playing an increasingly prominent role in health system management, as well as rising health expenditure, limited budgets, and competing demands. There is significant opportunity to embed health economic evaluations alongside clinical trials, particularly phase 3 trials, to increase research outputs and optimize research translation. Investing in clinical trial networks that support funding for a health economist or a health economic evaluation may be an effective strategy to increase the uptake of health economic evaluations alongside trials.

Human papillomavirus (HPV) trials: A cross-sectional analysis of clinical trials registries

ABSTRACT Every clinical trial must be registered in a publicly accessible trial registry before enrollment of the first participant. Prospectively registering clinical trials before enrolling participants helps to prevent unethical research misconduct from occurring, duplication of research and increases transparency in research. The aim of this study was to provide cross-sectional survey analysis of planned, ongoing and completed human papillomavirus (HPV) clinical trials conducted worldwide. We searched the International Clinical Trials Registry Platform (ICTR) for registered HPV trials on 5 March 2023. Two authors independently extracted data including name of the clinical trial registry, location of the trial, recruitment status of the trial, gender of participants, phase of the trial, and type of trial sponsor. We used Microsoft Excel to perform descriptive analysis. The search yielded 1632 trials registered between 1999 and 2023. Most of the trials were registered in ClinicalTrials.gov and were registered retrospectively. We also found that most trials were conducted in North America, in recruiting stage, and indicated “not applicable” under the phase of the trial field. Finally, most trials were sponsored by hospitals. Our study found that there are many HPV clinical trials registered in different clinical trial primary registries around the world. However, many of the trials were registered retrospectively instead of the required prospectively and some had missing fields. Therefore, there is a need for registries to promote prospective trial registration and completion of all fields during the registration process.

Commercial Opportunity or Addressing Unmet Needs-Loop-Mediated Isothermal Amplification (LAMP) as the Future of Rapid Diagnostic Testing?

Loop-Mediated Isothermal Amplification (LAMP) technology is emerging as a rapid pathogen testing method, potentially challenging the RT-PCR "gold standard". Despite recent advancements, LAMP's widespread adoption remains limited. This study provides a comprehensive market overview and assesses future growth prospects to aid stakeholders in strategic decision-making and policy formulation. Using a dataset of 1134 LAMP patent documents, we analyzed lifecycle and geographic distribution, applicant profiles, CPC code classifications, and patent claims. Additionally, we examined clinical developments from 21 curated clinical trials, focusing on trends, geographic engagement, sponsor types, and the conditions and pathogens investigated. Our analysis highlights LAMP's potential as a promising rapid pathogen testing alternative, especially in resource-limited areas. It also reveals a gap between clinical research, which targets bacterial and parasitic diseases like malaria, leishmaniasis, and tuberculosis, and basic research and commercial efforts that prioritize viral diseases such as SARS-CoV-2 and influenza. European stakeholders emphasize the societal impact of addressing unmet needs in resource-limited areas, while American and Asian organizations focus more on research, innovation, and commercialization.

Trends in phase 1 oncology clinical trials across Australia; Analysis of ClinicalTrials.gov 2012-2022.

Phase 1 oncology trials provide access to new therapies and may improve cancer outcomes. Phase 1 trials conducted in the Asian-Pacific region are increasing at a faster rate than the global trend. This study aimed to describe the changing landscape of phase 1 oncology trials in Australia in the last decade. This cross-sectional study reviewed phase 1 oncology trials registered on ClinicalTrials.gov conducted in Australia. Phase 1 trials were included for analysis if they enrolled adults with solid organ malignancies, used at least one systemic agent, and were first registered between January 1, 2012, and December 31, 2022. The number of trials, site locations, sponsor type, and drug class were analyzed using descriptive statistics. Over the 10-year period, ClinicalTrials.gov included 493 phase 1 clinical trials across 71 Australian sites. Most sites were in metropolitan locations; in Melbourne, trials were concentrated within selected sites, while in Sydney, trials were spread across a larger number of sites. The number of phase 1 trials per annum increased from 18 in 2012 to 75 in 2022. Since 2020, emerging biopharmaceutical companies have become the predominant sponsor type, a trend that is also seen globally. While most trial sponsors were North American (42%), there was increasing representation from Asian sponsors over the 10-year period (6% in 2012 to 39% in 2022). Immunomodulatory (45%) and targeted approaches (44%) accounted for most drug classes used alone or in combination. There are an increasing number of phase 1 trials conducted within Australia. Sponsors of phase 1 trials are increasingly from Asian countries and are more likely to be emerging biopharmaceutical companies.

Postrecurrence Treatment in Neoadjuvant or Adjuvant FDA Registration Trials

In oncology randomized clinical trials, suboptimal access to best available care at recurrence (or relapse) may affect overall survival results. To assess the proportion and the quality of postrecurrence treatment received by patients enrolled in US Food and Drug Administration (FDA) registration trials of systemic therapy in the adjuvant or neoadjuvant setting. For this systematic review, all trials leading to an FDA approval from January 2018 through May 2023 were obtained from the FDA website and drug announcements. Randomized clinical trials of an anticancer drug in the neoadjuvant or the adjuvant setting were included. Trials of supportive care treatment and treatments given in combination with radiotherapy were excluded. Information abstracted for each trial included tumor type, setting, phase, type of sponsor, reporting and assessment of postrecurrence, and overall survival data. A total of 14 FDA trials met the inclusion criteria. Postrecurrence data were not available in 6 of 14 registration trials (43%). Of the 8 remaining trials, postrecurrence treatment was assessed as suboptimal in 6 (75%). Overall, only 2 of 14 trials (14%) had data assessed as appropriate. This systematic review found that 43% of randomized clinical trials of anticancer treatment in the adjuvant or neoadjuvant context failed to present any assessable postrecurrence treatment data. In instances in which these data were shared, postrecurrence treatment was suboptimal 75% of the time. The findings suggest that regulatory bodies should enforce rules stipulating that patients have access to the best standard of care at recurrence.

Principal Features of Industry-Funded Trials that Posted Informed Consent Forms on ClinicalTrials.gov: a Cross-Sectional Analysis.

We aim to characterize industry-funded trials that have posted the informed consent forms (ICFs), and to assess whether the role played by industry as 'sponsor' or 'collaborator' could impact several relevant variables. A cross-sectional study wasconducted on ClinicalTrials.gov on all industry-funded trials registered on or before 25 February 2023. We registered types of intervention, current recruitment status, design, enrollment, and countries involved. For trials with special interest to potential participants and investigators and/or clinicians an analysis of the role played by industry as 'sponsor' or 'collaborator' was performed. Of 116,281 industry-funded trials registered, 741 (0.6%) had posted ICFs. Most of these trials were categorized as 'completed' (n = 408) or 'terminated' (n = 107). The review of a sample of 359 trials showed that most were on drugs and/or biologics (59%), were randomized (51%), conducted exclusively in the USA (72%), and had posted results (79%), protocols (92%), and statistical analysis plans (SAPs) (89%). Trials in which industry participated as 'collaborator' were significantly more likely to post ICFs when trials were in the 'active, not recruiting' phase (OR 4.70, 99.71% CI 1.59-13.9, p < 0.001) than industry-sponsored trials. This was also the case when assessing drugs/biologics (OR 2.64, 99.71% CI 1.25-5.58, p < 0.001). Conversely, companies acting as 'sponsors' were significantly more likely to post ICFs with trials assessing devices, radiation interventions and/or diagnostic tests (OR 0.37, 99.71% CI 0.17-0.79, p < 0.001) than when participating as 'collaborators'. While industry-funded trials rarely post ICFs, when they do, they are highly compliant with transparency requirements. Regulations and ethics codes should consider requiring posting of protocols, SAPs, and ICFs for all clinical trials, regardless the type of sponsor.

The prevalence of RCTs in PARP and immune-checkpoint blockade combination trials: An appraisal of clinical evidence generation in oncology.

e23006 Background: PARP-inhibitors were developed to promote lethal genomic instability in cancers with homologous recombination repair (HRR) defects, ultimately receiving approval for patients with BRCA gene mutations. At the tumor microenvironment, DNA instability is linked to higher expression of immune activating signals such as PDL1. PDL1 is one of the primary targets for immune-checkpoint inhibitors (ICIs), receiving approval for numerous cancer types. In-vitro studies support mechanisms of possible synergy for PARP and ICIs in combination. Despite both therapy classes being available to oncologists for nearly a decade, the clinical benefit for these agents together remains unclear. Our study aims to appraise the global clinical trial landscape for trials testing combination PARP and PD1/PDL1 regimens. Methods: Search terms for all known approved or unapproved PD1/PDL1 and PARP inhibitors associated with trials registered on the National Library of Medicine’s website, clinicaltrials.gov, were included in the cohort as long as one interventional arm administered both agents. Qualitative and quantitative trial data features were collected from the Cancer Research Institute (CRI) Immuno-Oncology Intelligence Database and complemented with manually sourced information from trial registries and publications. Contribution of Effect (COE) was defined as trials with two or more arms that compare our combination regimen of interest to PARP or an ICI alone. The presence of randomization, eligibility for randomized-controlled trial (RCT) status as well as COE was determined by three reviewers separately with disagreements settled by committee decision. Results: In total, we found 188 clinical trials that enrolled 39,268 patients. A minority of 17 trials were phase I not considered as RCTs, leaving 37,827 patients across 171 trials for enrollment in phase II trials and beyond. Of these 171 trials, 80 (47 %) were single-arm studies without active comparator. Forty-nine (29%) used randomized assortment, 40 (23%) met criteria for an RCT and 33 (19%) met criteria for RCT with COE. In total, these 33 trials enrolled 14,803 patients. Of the 33, 17 (10%) enrolled patients with cancers that are approved for PARP blockade by the FDA and 11 (6%) employed genetic testing for HRR defects. Sponsorship ranged from 16 trials by industry, 6 by cooperative oncology group, 6 by academic institutions and 5 by the National Cancer Institute. Conclusions: Our study results highlight that the global clinical trial apparatus directs significant resources and patients towards trials with lower standards of evidence generation. Across sponsor types, there was a considerable number of trials that met the rigor of an RCT with COE. These findings show both promise and areas of improvement within the trial landscape to generate evidence relevant to the use of PARP and ICIs in combination.

Temporal trends and characteristics associated with racial, ethnic, and sex representation in COVID-19 clinical trials: A systematic review and meta-analysis

BackgroundEarly in the pandemic, extensive attention was cast on limited inclusion of historically underrepresented patient populations in COVID-19 clinical trials. How diverse representation improved following these initial reports remains unclear. MethodsPubMed, Embase and the Cochrane Library were searched (through April 2024) for US-based COVID-19 trials. Utilizing random-effects, we compared expected proportions of trial participants from racial and ethnic groups and of female sex between trials enrolling primarily in 2020 versus primarily 2021–2022. Meta-regression was performed to assess associations between trial characteristics and group representation. ResultsWe retrieved 157 studies comprising 198,012 participants. White (2020: 63.1% [95% CI, 60.8%–67.3%]; 2021–2022: 73.8% [95% CI, 71.5%–76.0%]) and female representation (2020: 46.1% [95% CI, 44.7%–47.4%)]; 2021–2022: 51.1% [95% CI, 49.3%–52.8%) increased across enrollment periods. Industry-sponsored trials were associated with higher White (coefficient, 0.10 [95% CI, 0.03–0.18]) and Hispanic or Latinx representation (coefficient, 0.16 [95% CI, 0.08–0.25]) and lower Asian (coefficient, −0.03 [95% CI, −0.06– –0.003]) and female representation (coefficient, −0.03 [95% CI, −0.07– –0.002]). Outpatient trials were associated with higher White (coefficient, 0.20 [95% CI, 0.13–0.26]) and female representation (coefficient, 0.16 [95% CI, 0.13–0.18]), and lower Black representation (coefficient, −0.10 [95% CI, −0.10– –0.08]). ConclusionsDespite improved female representation in COVID-19 trials over time, there was no clear increase in non-White representation. Trial characteristics such as primary sponsor, clinical setting, and intervention type correlate with representation of specific demographic groups and should be considered in future efforts to improve participant diversity.

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.

Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms.

Digital health technologies (DHTs) can enable more patient-centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting and structuring patient-generated data for regulators to use in approval decisions alongside traditional clinical outcomes. Although a growing body of evidence has documented increasing use of DHTs in clinical trials overall, the use of DHTs in clinical trials supporting medical product development is unclear; here, we quantify the use of DHTs in clinical trials sponsored by pharmaceutical and medical device firms. Despite interest from pharmaceutical and medical device manufacturers in DHTs, we find tepid uptake of DHTs in trials by these sponsor types over time. Further, to date, these sponsors have most frequently used conventional, hardware-based technologies that have been available for many years (e.g., Holter monitors and glucose meters) rather than newer activity monitors, mobile apps, and other online-based tools that are frequently used by non-industry sponsors. Considering the recent and evolving nature of regulatory guidance around DHT use in clinical trials, our findings suggest that organizations pursuing product development still appear hesitant to incorporate DHTs in trials that provide the most critical evidence for regulatory review and impact how new products are used. This suggests there are likely additional opportunities for sponsors of regulated trials to incorporate (more) DHTs and patient-centric endpoints into product development clinical trials. However, additional regulatory clarity and efforts to reduce operational barriers may be needed in order to more fully capture these opportunities.

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.

Beyond purchase intention in sports sponsorship: an alternative approach to measuring brand equity using best-worst scaling

PurposeThe purpose of this paper is to study the effects of sports sponsorship on brand equity using two managerially related outcomes: price premium and market share.Design/methodology/approachThis study uses a best–worst discrete choice experiment (BWDCE) and compares the outcome with that of the purchase intention scale, an established probabilistic measure of purchase intention. The total sample consists of 409 fans of three soccer teams sponsored by three different competing brands: Nike, Adidas and Puma.FindingsWith sports sponsorship, fans were willing to pay more for the sponsor’s product, with the sponsoring brand obtaining the highest market share. Prominent brands generally performed better than less prominent brands. The best–worst scaling method was also 35% more accurate in predicting brand choice than a purchase intention scale.Research limitations/implicationsFuture research could use the same method to study other types of sponsors, such as title sponsors or other product categories.Practical implicationsSponsorship managers can use this methodology to assess the return on investment in sponsorship engagement.Originality/valuePrior sponsorship studies on brand equity tend to ignore market share or fans’ willingness to pay a price premium for a sponsor’s goods and services. However, these two measures are crucial in assessing the effectiveness of sponsorship. This study demonstrates how to conduct such an assessment using the BWDCE method. It provides a clearer picture of sponsorship in terms of its economic value, which is more managerially useful.

Effectiveness of sponsorship type, sport team identification, team support and congruence

PurposeThe aim of this paper is to investigate the interaction effect that sponsor-team congruence and team fan (home/rival team) have on the influence of different types of sports sponsorship (joint, corporate social responsibility [CSR]-linked and conventional sponsorship) on fans' attitudes and purchase intentions toward the sponsor.Design/methodology/approachTwo experimental studies were conducted on 391 and 297 participants. The data gathered underwent analysis through five multivariate general linear model analyses.FindingsThe study found that CSR-linked sponsorship had the strongest positive impact and the weakest negative impact on the attitude and purchase intention of home team supporters and the attitude of rival team supporters. Nonetheless, the sponsor-team congruence did not significantly moderate the relationship. Additionally, the research demonstrated that the fan identity of both home and rival teams moderates the impact of sports sponsorships on attitude and purchase intention.Originality/valuePrevious research has studied the effectiveness of sponsorship format types independently. This is the first research comparing sponsorship formats regarding fan type and congruence.

Differences in Absolute Neutrophil Count Eligibility Criteria of Pediatric Phase I and Phase I/II Oncology Clinical Trials According to Sponsorship

Introduction: Racial clinical trial enrollment disparities in oncology are well documented ( Pediatr Blood Cancer. 2020 10.1002/pbc.28296). Barriers to enrollment are multifactorial and include structural and clinical barriers like restrictive eligibility criteria ( Am Soc Clin Oncol Educ Book. 2016 10.1200/EDBK_156686). Many phase I/II oncology clinical trials have laboratory criteria such as a minimum threshold for absolute neutrophil count (ANC). The Common Terminology Criteria for Adverse Events (CTCAE) defines an ANC of less than 1500 cells/µL as the upper limit of a grade 2 toxicity ( J Clin Oncol. 2010 10.1200/JCO.2009.24.3881), and this has become the minimum eligibility threshold in many oncology trials ( J Clin Oncol. 2017 10.1200/JCO.2017.73.4186). Using a minimum ANC of 1500 cells/µL may contribute to further racial enrollment disparities due to the Duffy null phenotype, which has a prevalence of ~65% in Black/African American individuals ( PLoS Genet. 2011 10.1371/journal.pgen.1002108) and results in a lower number of circulating neutrophils compared to people without the Duffy null phenotype ( Blood. 2021 10.1182/blood.2020008600). Up to 23% of pediatric patients with the Duffy null phenotype have ANCs &amp;lt;1500 cells/µL ( Blood Adv. 2023 10.1182/bloodadvances.2022007680). A recent adult multiple myeloma study found that the most common reason for ineligibility among Black patients was failure to meet hematologic laboratory criteria ( Blood. 2023 10.1182/blood.2022018657). Less is known about eligibility criteria as a barrier to enrollment in the pediatric cancer population. We hypothesized industry-sponsored trials would have more restrictive eligibility criteria than non-industry-sponsored trials. To explore this further we describe ANC eligibility criteria of pediatric oncology phase I/II clinical trials according to sponsorship. Methods: We analyzed ANC eligibility criteria of interventional phase I and phase I/II oncology trials opened in the United States from January 2010 to May 2023 using the ClinicalTrials.gov registry. Trials that included pediatric participants only (up to age 18), pediatric and adolescent young adult participants (up to age 39), and adult studies that allowed pediatric participants were included. We excluded trials for non-malignant conditions and trials that did not report ANC eligibility criteria. ANC eligibility criteria were categorized as ≥1500 cells/µL and &amp;lt;1500 cells/µL. Trials were compared according to primary sponsorship (industry vs non-industry). Secondary objective was to describe language requirements explicitly mentioned for these trials. Distribution of trial characteristics were compared using Fisher's exact or Chi-squared tests. Logistic regression was used to evaluate potential changes in ANC criteria over time (in years), using ANC&amp;lt;1500 cells/µL as the reference group. Results: We identified 861 interventional trials that met our initial inclusion criteria. After review of the trials, 36 were excluded for enrolling participants with non-malignant diagnoses. Of the remaining 825 studies, 438 (53%) had ANC eligibility criteria reported. 89 (20%) studies were industry-sponsored (Table 1). Trial phase, age eligibility, diagnosis, and results reported differed statistically significantly by sponsor type. 76 (17%) studies required ANC ≥1500 cells/µL for enrollment. For industry sponsored trials, 26 (29%) required ANC ≥1500, while 50 (14%) non-industry sponsored trials required ANC ≥1500, with a risk ratio of 2.04 (95% CI 1.35-3.08, p=0.002) (Figure 1). Almost all studies (96%) did not explicitly state language requirements, and this did not vary by sponsor type. There was no significant change in odds of a trial requiring ANC ≥1500 cells/µL over time (odds ratio 1.05, 95% CI 0.98-1.12, p=0.138). Conclusion: A minority of trials (17%) required an ANC ≥1500 cells/µL for enrollment on a phase I or phase I/II interventional clinical oncology trial; however, industry-sponsored trials were twice as likely than non-industry trials to require this higher ANC threshold. Further studies are needed to investigate laboratory criteria as a possible reason for racial enrollment disparities in pediatric cancer trials.

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.

Characteristics of registered research in peritoneal dialysis: Past and present.

Recent national policy changes in the United States and the continued growth of peritoneal dialysis (PD) as a therapy for end-stage kidney disease has renewed interest in this modality. The objective of this study was to describe the current landscape of PD clinical trials to assess trends and gaps in clinical research. An advanced search was completed through ClinicalTrials.gov, yielding 248 studies. Descriptive statistics and Fisher exact tests were used for statistical analysis. Most studies were completed (197, 79.4%), did not indicate a phase (143, 57.7%), were academically sponsored (156, 62.9%), or conducted in Asia (88, 35.5%). There has been overall growth in PD clinical trials since 1995. The type of phase was related to study location (p = 0.008). The type of study intervention was related to study recruitment status, sponsor type, and primary outcome (p = 0.030, p &lt; 0.001, p &lt; 0.001, respectively). Despite growth in PD research worldwide, more studies are being conducted outside the U.S., and static investment in U.S. government-sponsored PD research risks not achieving the goal of increasing availability of home dialysis.

Landscape of cancer clinical trials in India – a comprehensive analysis of the Clinical Trial Registry-India

Cancer is one of the leading causes of morbidity and mortality in India. Clinical trials are critical for driving innovation in cancer therapy, diagnosis, and prevention. This study aims to depict the evolving landscape of cancer clinical trials in India by analysing the clinical trials registered in Clinical Trial Registry-India (CTRI). We identified cancer trials registered in CTRI (between 2007 and 2021) using search terms adapted from the cancer types defined by the National Cancer Institute (USA). We then collated and analysed the publicly available information from CTRI (cancer subtypes, type of trial, treatment intent, type of intervention, sponsor type, recruitment countries) and used descriptive statistics to illustrate the overall as well as year-to-year trend. In total, we identified 1988 cancer trials, the majority of which focused on treating cancer (63%) and rest of the trials aimed at optimising the operational aspects of surgery (19%), mitigating treatment-related toxicity (10.6%), or treating cancer-related symptoms (7.8%). Focusing on trials with the intent of treating cancer, we found that most were investigating solid tumours as opposed to haematological malignancies with the most prominent cancer subtypes being breast cancer (17%), head and neck cancer (9.8%), lung cancer (9.6%), and cervical cancer (6.6%). The number of trials conducted in a given cancer subtype from our analysis overall correlated to the incidence, mortality, and 5-year prevalence of the respective cancer subtype in India; however, head and neck cancer and cervical cancer were underrepresented in trials as compared with the disease burden. The most common type of intervention was investigational drugs. The most common sponsor types were global pharmaceutical industry (26%) and research institution and hospital (26%). Despite a relatively high cancer burden, the availability of cancer trials in the Northeastern states of India was limited. There is a pressing need for clinical cancer research in India to be better aligned with the nation's healthcare needs and disease burden, focusing on prevalent and deadly cancers while ensuring the availability of clinical trials across geographic regions and underserved populations. Pi Health USA, a fully owned subsidiary of BeiGene Ltd.