Industry-sponsored Research Research Articles

Industry-Sponsored Research Funding to Urologists in the United States Between 2014 and 2022.

Urologists face challenges in obtaining public research funding, leading to increasing reliance on the industry for research support. This study aimed to examine the extent and trends in industry-sponsored research payments to urologists from 2014 to 2022 in the United States. We identified all US urologists using the Centers for Medicare and Medicaid Services National Plan and Provider Enumeration System database and extracted their industry-sponsored research payments data from the Centers for Medicare and Medicaid Services Open Payments Database. We performed descriptive analyses of the payments data. Among 13,902 US urologists, 1330 (9.6%) received at least one industry-sponsored research payment. Urologists received $605.1 million between 2014 and 2022. Of all research payments, 98.7% ($597.4 million) were associated research payments for research where urologists served as principal investigators. The top 10% of urologists in research payments received 79.3% ($480.0 million) of total research payments. Only 0.4% ($2.3 million) of research payments were for preclinical research, whereas registered clinical trials totaled $159.0 million (26.3% of all research payments). The annual value of research payments increased from $35.2 million in 2014 to $101.7 million in 2022. The average percentage change in total payments showed a significant annual increase of 13.9% (95% CI, 11.6%-16.3%; P < .001) in value. There was no significant trend in the number of urologists receiving research payments. Industry-sponsored research payments to urologists are substantial and have increased in both payment amount and number over time.

Trend Analysis of Industry-Sponsored Research Funding and Research Productivity in Orthopaedic Surgery Using the Open Payments Database.

Introduction Orthopedic surgery and industry work together in order to provide optimal patient care. The Open Payments Database (OPD), established in 2013, reports industry payments to physicians. This study analyzes the first five years of industry-sponsored research funding (ISRF) to orthopedic surgeonsand examines researchproductivity'seffect on ISRF. Methods The OPD was queried from 2014 to 2018 for research payments to orthopedic surgeons in the United States. H-indices and publication volume were queried using the Scopus database. The research payments were sub-categorized to surgeons in teaching hospitals, registered clinical trials, preclinical research, and domestic. Results Between 2014 and 2018, a total of $202.74 million in ISRF was made to 1718 orthopedic surgeons. The proportion of research payments associated with a registered clinical trial significantly increased from 9.62% of payments in 2014 to 42.19% of payments in 2018 (p=0.002). Zimmer Biomet Holdings, Inc. ($20.77 million) contributed the largest value of payments to the greatest number of orthopedic surgeons (n=337). The total value of research payments increased by $3855 for every five-unit increase of a surgeon's H-index (p<0.001) and $762 for every five additional publications (p<0.001). Conclusion Orthopedic surgeons affiliated with a teaching hospital or clinical trial receive more ISRF. There may be a relationship between research productivity and ISRF.

Trends in Industry-Sponsored Research Payments to Physician Principal Investigators

This cohort study investigates trends in total and per-physician industry-sponsored research payments to physician principal investigators from 2015 to 2022.

Analysis of Nursing Professionals Criteria Regarding the Application of Ostomy Devices at Each Stage of the Care Process

Objective: To analyze the opinions and criteria of nursing professionals regarding the use of ostomy devices at each stage of the care process, considering both the characteristics of the ostomy and the patient. Method: A multicentered, cross-sectional descriptive study based on a national survey conducted among nursing professionals involved in the care of ostomy patients. Results: Despite the availability of various ostomy devices in most centers, patients are typically instructed in the use of twopiece devices upon hospitalization, which potentially explains their higher frequency of use. Discussion and Conclusion: Case presentations or industry-sponsored research have been identified where the use of specific devices is not justified, but rather their characteristics. Conducting a nationwide survey provides a comprehensive understanding of the criteria followed by nursing professionals in the care and management of ostomy patients, as well as in the selection and/or change of ostomy devices

Climate footprint of industry-sponsored clinical research: an analysis of a phase-1 randomised clinical study and discussion of opportunities to reduce its impact

ObjectiveThis study aims to calculate the global warming potential, in carbon dioxide (CO2) equivalent emissions, from all in-scope activities involved in a phase-1 clinical study.DesignRetrospective analysis.Data sourceInternal data held by...

Advancing Treatments for Rare Renal Diseases: New Hopes and Opportunities to Address a High Unmet Need

Introduction: The etiology of chronic kidney disease (CKD) is varied and complex. Diabetes and hypertension comprise 2/3 of cases and rare conditions, including inherited genetic diseases, comprise 1/3. We previously reported a 54% increase in clinical studies in CKD in the last 10 years. Hypothesizing a greater increase in rare renal disease studies, we undertook further analysis of metadata from Clinicaltrials.gov. Methods: CT.gov was searched for 49 conditions determined to be rare renal diseases posted between Jan-2003 and Dec-2022. Studies were divided into 2 time periods: P1 (2003–2012) and P2 (2013–2022) and analyzed by study type, phase, indication, primary endpoint, population, and funding. Results: Studies increased significantly in P2 versus P1 (123%, p < 0.001) with the greatest rise in observational studies (283%, p < 0.001). Interventional studies increased 93% (p < 0.01), with the greatest rise in early phases (205%, p < 0.001). The most frequent indications were LN, ADPKD, and IgA nephropathy; all increased 77–166% in P2 (p < 0.05 – p < 0.001). Proteinuria was the most frequent primary endpoint, which increased 63% (p = 0.054). Studies with pediatric populations increased 78% (p < 0.01). Most studies were nonindustry funded; however, industry-funded studies increased by 225% (p < 0.001). Conclusion: Clinical research in rare renal diseases has increased significantly in the last 10 years, particularly in glomerular diseases (GDs) and ADPKD. Proteinuria correlates with outcomes in GD, which explains the high percentage of studies with this primary endpoint. Rare renal diseases disproportionately affect children and the rise in studies with pediatric populations is encouraging. The rise in observational studies may signal an increased focus on understanding the natural course and pathophysiology of disease, which may lead to new potential therapeutic targets and future interventional studies. The increase in industry-funded studies suggests basic science is translating into industry-sponsored research.

1307. Vaso-occlusive Crisis is Associated with Subsequent Osteomyelitis in Pediatric Sickle Cell Disease

Abstract Background Children with sickle cell disease (SCD) commonly develop microvascular infarcts of bone known as vaso-occlusive crisis (VOC) and are also at high risk of osteomyelitis (OM). VOC and OM can be challenging to distinguish due to overlapping clinical features. VOC might predispose to OM, or an initial misdiagnosis of OM as VOC might lead to delayed diagnosis of OM. This study aimed to test whether VOC was associated with subsequent development of OM in children with SCD. Methods A retrospective Pediatric Health Information System (PHIS) database study (2010-2021) was performed. ICD-code data related to common diagnoses in pediatric patients with SCD were extracted. The rate of VOC within 30 and 180 days preceding episodes of OM was compared to the rate preceding acute chest syndrome (ACS), another common diagnosis in children with SCD but unlikely to be anatomically related to OM. Odds ratios (OR) were used to evaluate the association between these diagnoses. Results Of 22,818 PHIS participants with SCD, 13,699; 450; and 7,327 had ≥ 1 episode of VOC, OM and ACS, respectively. The distribution of OM diagnoses was similar across pre-specified age groups (0-4, 5-12, and 13-18 years). The odds ratio of VOC preceding a diagnosis of OM vs. ACS was 2.15 within 30 days (95% CI: 1.82-2.54; p= 3.68 x 10-18), and within 180 days was 1.39 (95% CI: 1.20-1.62; p=2.04 x 10-5). VOC Preceding Osteomyelitis vs. Acute Chest Syndrome Conclusion VOC was significantly more common in the days preceding a diagnosis of OM than of ACS. The strength of association was stronger within 30 days prior to OM than 180 days. These results suggest possible misdiagnosis of OM since VOC might delay OM diagnosis in some cases, that recurrent VOC might be misdiagnosed as OM, or that VOC can directly contribute to risk of OM in some cases. Limitations of this study include possible incomplete adjustment for unmeasured variables which could confound the analysis. More research is needed to confirm and evaluate the mechanism behind this association. Understanding the relationship could lead to improved screening and treatment of both VOC and OM. Disclosures Joshua Wolf, MBBS, PhD, Karius Inc.: Grant/Research Support|Merck Inc.: Participation in industry-sponsored research Sandra Arnold, MD, Contrafect: Grant/Research Support|Enanta: Grant/Research Support|Moderna: Grant/Research Support|Pfizer: Grant/Research Support

Industry-Sponsored Research Payments to Gastroenterologists and Hepatologists in the United States Between 2014 and 2021.

Aim This cross-sectional study aimed to examine the scale and trends of industry-sponsored research payments to gastroenterologists and hepatologists in the United States from 2014 to 2021. Methods Using the Open Payments Database and the National Plan and Provider Enumeration System (NPPES), the study analyzed both grant and research payments made to individual gastroenterologists and associated payments made for research where gastroenterologists and hepatologists served as principal investigators. Results After adjusting for inflation, the study found that a total of $1.5 billion was allocated to gastroenterologists by 284 companies during this period. Only 15.9% of the 20,986 gastroenterologists received at least one research payment, with associated research payments accounting for 97.6% of all payments. The study also revealed a significant increase in the number of gastroenterologists receiving associated research payments and a more than twofold increase in payments for registered clinical trials from 2014 to 2021. Conclusion The healthcare industry allocated large amounts of research funding to gastroenterologists and hepatologists. The study underscores the critical role of industry-sponsored clinical trials in advancing gastroenterological research and treatments.

Impact of Reporting Bias, Conflict of Interest, and Funding Sources on Quality of Orthopaedic Research

BackgroundInfluence of factors like reporting outcomes, conflicts of interest, and funding sources on study outcomes, particularly positive outcomes in orthopedics, remains underexplored. As transparency of partnerships in orthopaedic surgery through conflicts of interest statements has increased over the years, there has been a lack of focus on the value of these partnerships in influencing study outcomes. We aimed to investigate the associations between reporting outcomes, conflicts of interest, and sources of funding on study outcomes. MethodsWe reviewed articles published in 1 year in The Journal of Bone and Joint Surgery, The American Journal of Sports Medicine, and The Journal of Arthroplasty. The abstracts were examined for appropriate inclusion, while the authors’ names, academic degrees, funding disclosures, and departmental and institutional affiliations were redacted. There were a total of 1,351 publications reviewed from January 1, 2021 to December 31, 2021. ResultsA significant association was found between positive outcomes and reported conflicts of interest (75% versus 25%, P < .001). Likewise, conflicts of interest showed significant association with industry-sponsored studies (88% versus 12%, P < .001) and evidence level > II (72% versus 28%, P < .001). Industry-sponsored research accounted for the highest percentage of studies involving a conflict of interest (88%) and level I studies (12%). ConclusionsConflicts of interest are significantly associated with positive outcomes in orthopaedics. Sponsored studies were more inclined to have conflicts of interest and accounted for the majority of level I studies.

Registering transparency: the making of the international clinical trial registry platform by the world health organization (2004–2006)

BackgroundThis paper examines the events and conditions that led to the creation of the International Clinical Trials Registry Platform (ICTRP) in 2006 by the World Health Organization (WHO), and how the WHO addressed the issue of transparency in global pharmaceutical research. Using historical textual analysis, I trace the scientific debates that advocated for the establishment of official clinical trial registries in medical journals, and the sequence of actions following the GSK Paxil scandal in 2004, identifying the major ethical and scientific arguments that led to the involvement of the WHO as a key actor in trial registration in the context of the Big Pharma business model.ResultsThrough the questions “Why register?” and “Why registries?” as a roadmap, I examine the issues of publication bias and selective reporting by the industry, scrutinizing two ways in which the practice of publication bias damaged transparency in industry-sponsored research. The first involved ethical concerns regarding human subject exploitation and concealing of negative results. The second addresses the deterioration of the certainty of evidence due to incomplete access to trials results. By reviewing the series of events that occurred between 2004 and 2006 –between the Paxil scandal and the launch of the ICTRP—, I analyze the actions taken by the different actors involved: (1) the International Committee of Medical Journal Editors (ICMJE) and the creation of the Ottawa Group; (2) the WHO, beginning with the Ministerial Summit on Health Research held in November of 2004, and (3) the responses of the pharmaceutical industry and specifically GSK to the call for transparency and trial registration.ConclusionsThe history of trial registration through the ICTRP as a dataveillance apparatus shows the difficulty of regulating a health enterprise turned into a global business. Moreover, it shows the challenges of globalization and how easier and faster it is to globalize business compared to good practices, raising the question of why it has been so hard to undo these trends. Indeed, the history of the movement for trial registration is not a history of regulation success, or at least not yet.

Industry-Sponsored Research Funding to Rheumatologists in the United States Between 2014 and 2022.

Rheumatologists are responsible for conducting research on, managing, and treating major autoimmune diseases (AIDs) such as rheumatoid arthritis (RA), systemic lupus erythematosus, and psoriasis. AIDs afflict up to 23.5 million people in the United States.

From seed to harvest: 18-month experience of molecular tumor board (MTB)-based precision oncology practice at the Verona University Hospital.

e15065 Background: Next generation Sequencing (NGS) allows the identification of potentially actionable molecular alterations that may constitute a therapeutic opportunity beyond standard systemic treatments for advanced cancer patients (pts). The interpretation of NGS profiling and its introduction in clinical practice can be guided by systematic implementation of Molecular Tumor Board (MTB). Methods: Between May 2020 and January 2023, 663 cancer pts accessed NGS profiling, in the context of investigator-driven and/or industry-sponsored research programs, using the CORE panel (in-house developed in collaboration with the International Cancer Genome Consortium - ICGC, covering 174 clinically relevant genes, structural variations and genomic signatures; 411 pts) and commercial FoundationOne CDx or FoundationOne Liquid assays (131 and 27 respectively). Pts with potentially clinically relevant molecular alterations were prescreened by Pathology and Oncology dedicated professionals and within multidisciplinary disease-oriented teams. Here we describe the results of MTB discussions at the Verona University Hospital. Results: Sixty-seven pts (10% of those profiled) were discussed at MTB bi-weekly meetings, between July 2021 and January 2023. Further diagnostic tests were requested in 19 pts (28%; IHC: 7, molecular analyses: 10, re-biopsies: 3). In 1 case histological diagnosis was changed upon re-biopsy (acinar pancreatic cancer to breast cancer NOS). Oncogenetic counselling was proposed in 10 pts (15%). Forty pts (60% of those discussed) were deemed eligible for NGS-informed treatment. Among these, twenty-two pts (55%) did not start MTB-indicated therapy, due to currently non-progressive disease (11), clinical deterioration (7), other Center referral (3) or refusal (1). Eighteen pts (45%) started MTB-recommended therapy in first (17%), second (28%) or &gt; = third line (55%). Treated pts were affected by rare tumors (8), pancreatic cancer (5), NSCLC (2), biliary tract, colon, and breast cancer (1 patient each). Types of treatment were: 12 targeted-, 2 immuno-, 2 chemo-, 2 combined-therapies. Among twelve evaluable pts, one complete response (8%), seven partial responses (58%), two stable (16%) and two progressive diseases (16%) were observed (RECIST v1.1); median PFS in treated pts was 12.7 [0.1-17.7] months. Five pts (41%) are currently awaiting response evaluation. Conclusions: Systematic identification and discussion of potentially actionable gene alterations brought to NGS-informed, MTB-endorsed therapeutic indications in 6% of profiled pts, 65% of whom experienced relevant clinical benefit from treatment. Increased and timely (preferably at diagnosis) access to NGS profiling, revised criteria for and more extensive MTB discussions should be implemented to increase the impact of Precision Oncology practices on pts' outcome.

Is Industry- Versus Government-Sponsored Research a Zero-Sum Game?

Is Industry- Versus Government-Sponsored Research a Zero-Sum Game?

Pro-Con Debate: Interdisciplinary Perspectives on Industry-Sponsored Research.

Pro: Nearly all new devices and drugs come from industry that provides two-thirds of the funding for medical research, and a much higher fraction of clinical research. Realistically, without corporate-funded studies, perioperative research would stagnate with little innovation and few new products. Opinions are ubiquitous and normal, but do not constitute epidemiologic bias. Competent clinical research includes many protections against selection and measurement bias, and the publication process provides at least moderate protection against misinterpretation of results. Trial registries largely prevent selective data presentation. Sponsored trials are particularly protected against inappropriate corporate influence because they are usually codesigned with the US Food and Drug Administration, and analyses are based on formal predefined statistical plans, as well as being conducted with rigorous external monitoring. Novel products, which are essential for advances in clinical care, largely come from industry, and industry appropriately funds much of the required research. We should celebrate industry's contribution to improvements in clinical care. Con: While industry funding contributes to research and discovery, examples of industry-funded research demonstrate bias. In the setting of financial pressures and potential conflict of interest, bias can influence the type of study design, hypotheses being tested, rigor and transparency in data analysis, interpretation, as well as reporting of the results. Unlike public granting agencies, industry does not necessarily provide funding based on unbiased peer review following an open call for proposals. The focus on success can influence the choice of a comparator, which might not be ideal among the possible alternatives, the language used in the publication, and even the ability to publish. Unpublished negative trials can result in selected information being withheld from the scientific community and the public. Appropriate safeguards are needed to ensure that research addresses the most important and relevant questions, that results are available even when they do not support the use of a product produced by the funding company, that populations studied reflect the relevant patients, that the most rigorous approaches are applied, that studies have the appropriate power to address the question posed, and that conclusions are presented in an unbiased manner.

Pro-Con Debate: Interdisciplinary Perspectives on Industry-Sponsored Research

ProNearly all new devices and drugs come from industry that provides two-thirds of the funding for medical research, and a much higher fraction of clinical research. Realistically, without corporate-funded studies, perioperative research would stagnate with little innovation and few new products. Opinions are ubiquitous and normal but do not constitute epidemiologic bias. Competent clinical research includes many protections against selection and measurement bias, and the publication process provides at least moderate protection against misinterpretation of results. Trial registries largely prevent selective data presentation. Sponsored trials are particularly protected against inappropriate corporate influence because they are usually codesigned with the US Food and Drug Administration, and analyses are based on formal predefined statistical plans, as well as being conducted with rigorous external monitoring. Novel products, which are essential for advances in clinical care, largely come from industry, and industry appropriately funds much of the required research. We should celebrate industry’s contribution to improvements in clinical care. ConWhile industry funding contributes to research and discovery, examples of industry-funded research demonstrate bias. In the setting of financial pressures and potential conflict of interest, bias can influence the type of study design, hypotheses being tested, rigor and transparency in data analysis, interpretation, as well as reporting of the results. Unlike public granting agencies, industry does not necessarily provide funding based on unbiased peer review following an open call for proposals. The focus on success can influence the choice of a comparator, which might not be ideal among the possible alternatives, the language used in the publication, and even the ability to publish. Unpublished negative trials can result in selected information being withheld from the scientific community and the public. Appropriate safeguards are needed to ensure that research addresses the most important and relevant questions, that results are available even when they do not support the use of a product produced by the funding company, that populations studied reflect the relevant patients, that the most rigorous approaches are applied, that studies have the appropriate power to address the question posed, and that conclusions are presented in an unbiased manner.

Comment on “The Evolution of University–Industry Linkages in Thailand”

Thailand has set itself the target of becoming a developed country by 2037. To achieve this goal, the nation must enhance its technological capabilities to produce higher-value-added products. Over the past two decades, Thailand has worked to improve its competitiveness through innovation by increasing research and development (R&D) investment. The country's gross domestic expenditure on R&D (GERD) rose from 0.25% of the gross domestic product (GDP) in 2000 to 1.33% in 2020. This is driven by a significant increase in private sector R&D expenditure, which rose from 35% of total GERD in 2000 to 68% in 2020. However, firms' R&D output performance, as measured by granted patents, has seen slower progress (Rattanakhamfu & Itthiphatwong, 2019). Some have argued that this is due to weak university-industry linkages (UILs). In fact, 15 years ago, Brimble and Doner (2007) emphasized the role of university–industry linkages (UILs) in Thailand's technological competencies. Based on their analysis of four sectors—the automotive sector, the textile and garment sector, the agro-industry, and the electronics sector—Brimble and Doner concluded that Thai UILs played a very limited role in the country's economic development. They attributed weak UILs to low competition in the domestic market, inefficient structures and weak incentives in Thai universities, and the fragmentation of the Thai bureaucracy. Intarakumnerd and Jutarosaga (2023) contribute to the existing literature by examining the role of UILs in three sectors, namely the automotive sector, the electronics sector, and the pharmaceutical sector, based on their analysis of R&D and Innovation (RDI) Surveys between 2014 and 2018 and case studies. They find that despite significant development in the higher education system over the past two decades, Thailand's UILs remain weak. Most UIL activities focus on human resource development, particularly student internships and employee training. Research-related linkages are particularly weak. Among the sectors studied, the pharmaceutical and electronics industries appear to have stronger ties with universities than the automotive sector. In summary, Intarakumnerd and Jutarosaga offer valuable insights into the evolution of UILs in Thailand. To further enhance their contribution to the field, Intarakumnerd and Jutarosaga should consider the following revisions: First, by providing descriptive statistics on the firms in the sample so that readers can understand the firms' characteristics from the RDI survey, such as firm size and nationality. Although Intarakumnerd and Jutarosaga argue that there is a bias towards large firms, as all have asset sizes of more than THB 10 million, this is not the case when firm size is measured by sales. In fact, the proportion of small, medium, and large firms are relatively equal (each around 30%–39%) in all survey years. Second, by offering recommendations to improve not only student internships but also other underdeveloped UIL forms in Thailand, such as research partnerships, technology transfers, and industry-sponsored research.

170. Utilizing big data to determine the safety profile of recombinant human BMP-2 in spinal fusion surgery: an analysis of 5 databases from 2003 to 2017

<h3>BACKGROUND CONTEXT</h3> The use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion remains controversial. While rhBMP-2 safety concerns revealed misrepresentations in industry-sponsored research, previous observational studies reached conflicting conclusions regarding rhBMP-2 safety and effectiveness. rhBMP-2 is FDA approved for lumbar fusion with specific fusion devices. <h3>PURPOSE</h3> The purpose of the study was to investigate the complications associated with the use of rhBMP-2 for spinal fusion at a population-based level to determine its risk. <h3>STUDY DESIGN/SETTING</h3> The study design was a retrospective observational comparative cohort design comparing a target group to a comparator group for the risk of an outcome. <h3>PATIENT SAMPLE</h3> The patient sample comprised of two groups. Our target group consisted of first-time recipients of any spinal fusion procedure, of at least 18 years of age at the time of procedure, who received rhBMP-2 at the time of the procedure. Our comparator group consisted of first-time recipients of any spinal fusion procedure, who did not receive rhBMP-2. We restricted the study dates from 1/1/2003, when rhBMP-2 was introduced to the market, to 12/31/2017. <h3>OUTCOME MEASURES</h3> The outcome measures investigated included any reoperations requiring refusion and postoperative complications, which comprised of infection, seroma/hematoma, radiculitis, heterotopic ossification and cancer. The analysis of cancer included 18 subtypes of benign and malignant neoplasms. The observation period for these outcomes started after the date of surgery and concluded at the end of the study period. <h3>METHODS</h3> We utilized research tools developed in the Observational Health Data Sciences and Informatics (OHDSI) community (Hripcsak et al, 2015) to develop a common research protocol and data vocabulary encompassing the four claims databases and one electronic records database. The four insurance claims databases were IBM MarketScan Commercial Claims and Encounters (US employer-based private payer; patient aged 65 years or older), Optum ClinFormatics (US private payer; primarily aged 65 years or younger), IBM MarketScan Medicare Supplemental Beneficiaries (US retirees; patients aged > 65 years), IBM MarketScan Multi-state Medicaid (US Medicaid enrollees; all ages). The electronic health record database is Optum Pan-Therapeutic (US health systems; all ages). We then implemented a suite of methods and analyses to address confounding and bias inherent to observation studies, including propensity scoring and estimation of hazard ratios using a stratified Cox proportional hazard model. We combined the estimates from the data sources into a summary HR using a random effects model meta-analysis. To control for unmeasured confounding, we employed negative and positive controls to quantify the systemic bias in the system and compute adjusted HR estimates and confidence intervals. <h3>RESULTS</h3> Across all five databases, 60,427 patients were identified in the target group and 349,771 patients were identified in the comparator group, totaling 161,213 and 923,822 years of patient observation, respectively. rhBMP-2 was associated with statistically significantly fewer postoperative infections, with a hazard ratio of 0.88 (95% CI: 0.78-0.99). No significant difference was seen with the other outcomes, including reoperations for refusion, seroma/hematoma, radiculitis, heterotopic ossification, and development of benign or malignant neoplasms. Substantial control of measured confounding was demonstrated by propensity score adjustment, and negative and positive controls revealed noticeable residual bias that was controlled for through confidence interval calibration. <h3>CONCLUSIONS</h3> In the largest longitudinal observational study to date, rhBMP-2 was determined to be safe and effective as compared to non-rhBMP-2 usage in spinal fusion, with lower rate of postoperative infections. Importantly, no increased rates of cancer were detected. Coding error and the retrospective design may be an important source of bias. Despite these limitations, the large population size and statistical design give considerable significance to the results and conclusions of this study. <h3>FDA DEVICE/DRUG STATUS</h3> Medtronic Infuse (Approved for this indication).

A Viewpoint on the Quality of Digital Health Industry-Sponsored Research and Potential Threat to Patient Care (Preprint)

A Viewpoint on the Quality of Digital Health Industry-Sponsored Research and Potential Threat to Patient Care (Preprint)

Pouring rights contracts between universities and beverage companies: Provisions related to scientific research

Pouring rights contracts between universities and beverage companies are common and grant companies the exclusive right to serve, sell, and market specific beverages on campuses. In exchange, universities receive financial payments and other incentives. At the same time, beverage industry-sponsored research at universities has increased. Pouring rights contracts may include provisions that allocate funds for or place limitations on scientific research. In this cross-sectional study, we assessed whether pouring rights contracts contained provisions that allocated funds for or placed limitations on scientific research. From 2019 to 2020, we obtained contracts through requests under public records laws from US universities (public, 4-year, ≥ 20,000 students) with contracts active 2018–2019. Of the 143 requests, 6 did not have contracts and 9 declined to provide contracts. Our final sample included 131 contracts from 124 universities in 38 states. Thirty contracts (22.9%) referenced research (18 Coke; 12 Pepsi). Three contracts (2.3%) included provisions that made direct grants or gifts of research funding, 3 (2.3%) permitted the university to acknowledge funding from competitors, and 26 (19.8%) allowed for research using beverages from competing companies. Given increases in industry-sponsored research, the absence of provisions that made direct grants or gifts of research funding suggests that sponsorship of research is occurring through other mechanisms. Additionally, universities must be able to acknowledge funding and conduct research on any beverage and should not need permission via contract provisions to do so. Future studies should consider practical implications of these provisions in pouring rights contracts and assess whether they facilitate or hinder research.

Editorial introduction.

Current Opinion in Obstetrics and Gynecology was launched in 1989. It is one of a successful series of review journals whose unique format is designed to provide a systematic and critical assessment of the literature as presented in the many primary journals. The field of obstetrics and gynecology is divided into nine sections that are reviewed once a year. Each section is assigned a Section Editor, a leading authority in the area, who identifies the most important topics at that time. Here we are pleased to introduce the Journal's Section Editors for this issue. SECTION EDITOR Emre SeliEmre SeliEmre Seli, MD, is Professor of Obstetrics, Gynecology, and Reproductive Sciences at Yale School of Medicine, USA. Dr Seli received his medical degree from the University of Istanbul, Turkey, and completed his residency in obstetrics and gynecology at Yale University. His postdoctoral training included a fellowship in reproductive endocrinology and infertility as well as a research fellowship in molecular biology, both at Yale University. The primary focus of his research program is to understand and treat infertility. His laboratory characterized mechanisms regulating translational activation of gene expression in the oocyte. Dr Seli and his colleagues also made seminal contributions to our understanding of oocyte and embryo competence in IVF and the potential role of non-invasive diagnostic technologies in this context. Dr Seli is the recipient of many National Institutes of Health (NIH) and pharmaceutical industry-sponsored research grants. He has trained more than 50 pre- and post-doctoral fellows, published more than 100 scientific articles, and received numerous research awards, including the Ira and Ester Rosenwaks New Investigator Award from the American Society for Reproductive Medicine (ASRM), and the President's Achievement Award from the Society for Reproductive Investigation (SRI). Dr Seli's current research focuses on determinants of oocyte and embryo health, and mechanisms of ovarian ageing. Dr Seli is actively involved in professional societies and scientific journals. He served as the Program Director for SRI in 2016, where he is now the Program Committee Chair (2016–2021). He has also been a member of the ASRM Research Committee for the past five years, and served as a member of the SSR Program Committee, where he organized the Ovarian Workshop in 2016 and 2018. He is the Associate Editor for Molecular Human Reproduction, Reproductive Sciences, Journal of Assisted Reproduction and Genetics, and Reproductive Biomedicine Online, and is currently co-editor of Current Opinion in Obstetrics and Gynecology. As an educator, Dr Seli delivered more than 150 invited lectures nationally and internationally, and he is the recipient of the Association of Professors of Gynecology and Obstetrics (APGO) Excellence in Teaching Award based on evaluations of his lectures by Yale Medical Students. Dr Seli edited four books (Non-invasive Management of Gynecologic Disorders, Infertility, Fertility Preservation, and Human Gametes and Pre-implantation Embryos: Assessment and Diagnosis) and is currently co-authoring the 9th edition of the Speroff's Clinical Gynecologic Endocrinology and Infertility. Juan Antonio García VelascoJuan Antonio García VelascoProfessor Juan Antonio García Velasco is Director of IVI RMA-Madrid, Spain. He gained his degree in medicine at Complutense University, Spain, in 1990, before going on to train as a specialist in obstetrics and gynecology at La Paz Hospital, Spain, between 1992 and 1995. Professor García Velasco gained his PhD in medicine and surgery at Autónoma University, Spain, in 1995. He then became a sub-specialist in reproductive endocrinology and infertility at Yale University, USA, in 1998. Professor García Velasco has published 122 scientific articles in impact journals along with 22 chapters and four books. He is the Principal Investigator of projects funded by the Ministry of Education and the Ministry of Health. He is the Co-Editor of Reproductive Biomedicine Online (RBMO) and a member of the Editorial Committee of Fertility & Sterility (ASRM), Society for Gynecologic Investigation (SGI), European Society of Human Reproduction and Embryology (ESHRE), Spanish Society of Obstetrics (SEGO) and Gynecology and Spanish Society of Fertility (SEF).