Partnerships with the drug industry would be constructive
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PROVIDER: S-EPMC1128876 | biostudies-literature | 2003 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundIndustry and higher education sectors devote considerable, but independent resources to deliver postgraduate nursing education. This leads to duplication, uncertainty among students, and critical gaps in nursing education. Establishing and sustaining meaningful partnerships between invested university and industry stakeholders can strengthen workforce capability and improve patient care.MethodsTo evaluate the feasibility and effectiveness of using a University-Industry Integration Framework to develop a postgraduate nursing education program. Prospective mixed methods cohort study (STROBE). A co-design approach, using an established University-Industry Integration Framework, leveraged expert stakeholder partnerships to contextualise knowledge and service need for developing a postgraduate education program for cancer care nurses.ResultsAll participants (n = 46) were 100% satisfied with the online resources, support, and communication processes applied. Qualitative data generated three major analytical interpretations (reciprocity, flexible adaptations, authentic learning), highlighting the experiences and connections and how the partnership evolved. Program participants (n = 15) undertook a six-week cancer education program with eight responding to the survey with overwhelming satisfaction (100%), increasing their knowledge and skills. While barriers were evident, three quarters (n = 6) indicated these were addressed and enabled progress in the program. However, 63% (n = 5) were not satisfied with the program workload.ConclusionsUniversity and industry partners can apply the University-Industry Integration Framework and deliver a successful postgraduate education program for cancer care services. Within a co-design partnership it is possible to develop strategies and processes to overcome barriers and deliver a program for mutual benefit. The culmination of this successful education program has enhanced collaborations between partners and likely will sustain the offering of future co-design endeavours.
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Project description: Not available
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Project description:Hybrid games combine discrete, continuous, and adversarial dynamics. Differential game logic (
| S-EPMC7324283 | biostudies-literature
Project description:Recently, the US Food and Drug Administration and European Medicines Agency have issued new guidance for industry on drug interaction studies, which outline comprehensive recommendations on a broad range of in vitro and in vivo studies to evaluate drug-drug interaction (DDI) potential. This paper aims to provide an overview of these new recommendations and an in-depth scientifically based perspective on issues surrounding some of the recommended approaches in emerging areas, particularly, transporters and complex DDIs. We present a number of theoretical considerations and several case examples to demonstrate complexities in applying (1) the proposed transporter decision trees and associated criteria for studying a broad spectrum of transporters to derive actionable information and (2) the recommended model-based approaches at an early stage of drug development to prospectively predict DDIs involving time-dependent inhibition and mixed inhibition/induction of drug metabolizing enzymes. We hope to convey the need for conducting DDI studies on a case-by-case basis using a holistic scientifically based interrogative approach and to communicate the need for additional research to fill in knowledge gaps in these areas where the science is rapidly evolving to better ensure the safety and efficacy of new therapeutic agents.
| S-EPMC3691435 | biostudies-literature
Project description: Not available
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| S-EPMC6529850 | biostudies-literature
Project description:Memories of the past help us adaptively respond to similar situations in the future. Originally described by Schacter & Addis in 2007, the "constructive episodic simulation" hypothesis proposes that waking thought combines fragments of various past episodes into imagined simulations of events that may occur in the future. This same framework may be useful for understanding the function of dreaming. N = 48 college students were asked to identify waking life sources for a total of N = 469 dreams. Participants frequently traced dreams to at least one past or future episodic source (53.5% and 25.7% of dreams, respectively). Individual dreams were very often traced to multiple waking sources (43.9% of all dreams with content), with fragments of past memory incorporated into scenarios that anticipated future events. Waking-life dream sources are described in terms of their phenomenology and distribution across time and sleep stage, providing new evidence that dreams not only reflect the past, but also utilize memory in simulating potential futures.
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Project description:ObjectiveThe objective of this study was to estimate the provincial and nationwide costs of industry-sponsored drug clinical trials (CTs) in Canada.MethodsWe used the Aggregate Analysis of ClinicalTrials.gov (AACT) database, and included all industry-sponsored drug CTs that were conducted in Canada and completed in 2016. We estimated the costs of the study drugs using the market price. Estimates of the costs of management and patient services were based on industry contracts.ResultsThe sample included 394 CTs that were conducted in 2039 facilities in Canada and provided services for 20,126 Canadian enrollees. Two-thirds of the CTs (277 of 394) were in the non-cancer category. On average, the drug costs per patient were 89,680 Canadian dollars ($Can) during the lifespan of the CTs, and were higher in cancer CTs than in non-cancer CTs ($Can216,876 vs. $Can65,274). The total costs of industry-sponsored drug CTs completed in 2016 was $Can2093.7 million. Drug costs accounted for the majority of this total ($Can1804.9 million). Ontario ($Can781.2 million) and Quebec ($Can757.5 million) had the highest costs.ConclusionThe costs of industry-sponsored drug CTs completed in 2016 when measured in terms of market prices in Canada were valued at $Can2.1 billion.
| S-EPMC7248139 | biostudies-literature
Project description: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, examining 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 designs, outcomes, and completion times. 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.
| S-EPMC11607594 | biostudies-literature
Project description:Pharmaceutical companies market to physicians through individual detailing accompanied by monetary or in-kind transfers. Large compensation payments to a small number of physicians account for most of this promotional spending. Studying US promotional payments and prescriptions for anticoagulant drugs, we investigate how peer influence broadens the payments' reach. Following a compensation payment, prescriptions for the marketed drug increase by both the paid physician and the paid physician's peers. Payments increase prescriptions to both recommended and contraindicated patients. Over three years, marketed anticoagulant prescriptions rose 23 percent due to payments, with peer spillovers contributing a quarter of the increase.
| S-EPMC9387671 | biostudies-literature