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OBJECTIVES: The functional food market has experienced significant growth, leading to an uptick in clinical trials conducted by contract research organizations (CROs). Research focusing on CRO-managed trials and the communication of trial outcomes to the consumer market remains underexplored. This metaepidemiological study aims to evaluate the quality of randomized controlled trials (RCTs) facilitated by prominent CROs in Japan and to examine the quality of the representations used to convey their results to consumers. STUDY DESIGN AND SETTING: This study focused on the food trials that were registered in the University Hospital Medical Information Network Clinical Trial Registry or the International Clinical Trials Registry Platform by the top 5 CROs. Press releases of study results or advertisements of food products based on the study results were identified by conducting a Google search. The risk of bias in the RCT publications was independently assessed by 2 reviewers, who also evaluated the presence of "spin" in the abstracts and full texts. An assessment of "spin" in press releases/advertisements was undertaken. RESULTS: A total of 76 RCT registrations, 32 RCT publications, and 11 press releases/advertisements were included. Approximately 72% of the RCT publications exhibited a high risk of bias due to selective outcome reporting. "Spin" was present in the results of the abstract (72%), abstract conclusion (81%), full-text results (44%), and full-text conclusion (84%). "Spin" appeared in 73% of press releases/advertisements due to the selective outcome reporting. CONCLUSION: Functional food presentations in Japan frequently contained "spin." The Japanese government should more rigorously check whether food manufacturers report outcomes selectively.

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With the burgeoning numbers of clinical trials, the competition among sponsors for research subjects has grown intensely. Many clinical trials fail to meet their recruitment goals. Contract research organizations (CROs) that help conduct all or portions of a clinical study have transitioned from highly specialized niches, such as biostatistical analysis or regulatory compliance, to more overall functions to keep a trial moving forward. CROs establish agreements with sponsors, including how much a site will be paid per study subject. CROs are locked into that pricing, but over the course of a study's recruitment period, sponsors with deeper pockets may step in and offer more compensation per subject. The result is a competitive market place that favors big sponsors and puts smaller CROs and start-ups at a disadvantage.

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Clinical imaging research is a fast-growing, complex, and integral part of drug and therapy discovery and development. Research sponsors rely on outside vendors to manage their trials and deliver results they hope will demonstrate the efficacy of their product. Specialized vendors known as imaging contract research organizations have teams of highly trained and specialized professionals who lend their expertise to all aspects of imaging research management, of which nuclear medicine technologists are key team members. This article is part of the Clinical Trials Network Research Series for Technologists and will help provide an overview of an imaging research study from initiation to data delivery and the roles that nuclear medicine technologists and other imaging professionals play.

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Despite the existence of good clinical practice guidelines, the way in which they are applied to the bioanalytical laboratory remains unclear. Aspects of patient confidentiality, informed consent and subject withdrawal; addressing unblinding associated with sample analysis, including repeat analysis and incurred sample reanalysis; or the differences in responsibilities between the sponsor and contract research organization are not articulated by the US FDA within the bioanalytical setting, and for most bioanalytical laboratories this remains a gap in their standard operating procedures. The aim of this article is to identify and clarify the aspects of the good clinical practices that are applicable to the bioanalytical laboratory when conducting bioanalysis with clinical samples, and to address potential gaps in the bioanalytical laboratory when it comes to clinical sample bioanalysis.

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Objective: Dermatology and aesthetic medicine has experienced significant growth in recent years, driven by industry-sponsored research performed by clinical investigators. Contract research organizations (CROs) play an important role to ensure clinical trials are run efficiently, ethically, and according to Good Clinical Practice. An advisory group of dermatologists and aesthetic researchers was assembled to obtain feedback about CRO experiences for developing a "next-generation" specialty CRO for dermatology and aesthetic medicine. Methods: Experienced dermatologists and aesthetic physician researchers convened during the 2022 Winter Dermatology Annual Meeting in Kauai, Hawaii, to discuss experiences and make suggestions regarding CROs. Topics included positive and negative aspects of CRO experiences, desirable CRO services, and how CROs can be improved. Results: Benefits of working with CROs include project, data, and resource management and availability of technology. Desired functions include rapid study start-up, subject recruitment, and accurate and organized site-related documentation. Other qualities include access to large subject populations close to study locations, use of CRO-based clinical research assistants to support principal investigators across study sites, and scientific consultation, protocol development, medical writing, project management, clinical and medical monitoring, data management, biostatistics, and pharmacovigilance. Conclusion: CROs serve a vital role in the development process of drug, device, and therapeutics; however, it is important that changes to traditional CRO models are made to provide improved interactions with researchers in dermatology and aesthetic medicine.

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Objective: Dermatology and aesthetic medicine has experienced significant growth in recent years, driven by industry-sponsored research performed by clinical investigators. Contract research organizations (CROs) play an important role to ensure clinical trials are run efficiently, ethically, and according to Good Clinical Practice. An advisory group of dermatologists and aesthetic researchers was assembled to obtain feedback about CRO experiences for developing a "next-generation" specialty CRO for dermatology and aesthetic medicine. Methods: Experienced dermatologists and aesthetic physician researchers convened during the 2022 Winter Dermatology Annual Meeting in Kauai, Hawaii, to discuss experiences and make suggestions regarding CROs. Topics included positive and negative aspects of CRO experiences, desirable CRO services, and how CROs can be improved. Results: Benefits of working with CROs include project, data, and resource management and availability of technology. Desired functions include rapid study start-up, subject recruitment, and accurate and organized site-related documentation. Other qualities include access to large subject populations close to study locations, use of CRO-based clinical research assistants to support principal investigators across study sites, and scientific consultation, protocol development, medical writing, project management, clinical and medical monitoring, data management, biostatistics, and pharmacovigilance. Conclusion: CROs serve a vital role in the development process of drug, device, and therapeutics; however, it is important that changes to traditional CRO models are made to provide improved interactions with researchers in dermatology and aesthetic medicine.

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BACKGROUND: The pharmaceutical industry is forced to contain costs by outsourcing drug testing to commercial contract research organizations (CROs). This ensures the performance of clinical trials by experienced employees who must competently and skillfully exercise due care and diligence. Skilled talent for demanding CRO's is scarce, expensive and hard to retain. Evidence from empirical examinations in the CRO industry will be valuable for decision-makers. The lack of employee engagement and the neglect of employee well-being has financially harmful implications for industries with high job demands. OBJECTIVE(S): This study investigated the relationship between supervisor support, the satisfaction of self-determination needs and engagement at work, emotional exhaustion and intention to leave in a CRO. METHODS: A quantitative, cross-sectional approach was employed. Participants comprised a convenience sample of 260 CRO-employed males and females 18 years and older with different education and tenure levels. Structural equation modelling (SEM) was used to test the validity of a specified model. Raykov's reliability was utilized to evaluate internal consistency, and data were summarized descriptively. Coefficients of correlation and Cohen's d effect size were computed to assess relationships. The SEM model tested direct and indirect effects. RESULTS: The validated and reliable model found an improvement in supervisor support and satisfaction of self-determination needs would predict work engagement, reduced emotional exhaustion and intentions to leave amongst the CRO sample. Results also show that work engagement would affect emotional exhaustion and turnover intentions via satisfaction of self-determined needs. CONCLUSIONS: The study highlights the importance of the relationship between supervisor support, satisfaction of self-determination needs, employee engagement and well-being in a demanding organization. Although supervisor support is associated with improved work engagement and employee well-being, the improvement of satisfaction of self-determination needs should not be neglected in organizations with high job demands where talent retention is critical.

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With decommissioning of internal regulated bioanalytical (BA) and toxicokinetic (TK) capabilities, Novartis has relied on external service providers (ESPs) for all nonclinical LC-MS BA and majority of the associated TK work since 2017. This paper outlines an integrated outsourcing practice of the Novartis nonclinical LC-MS BA/TK group, which covers the roles and responsibilities of Novartis nonclinical LC-MS BA/TK expert scientific monitors, selection of ESPs for Novartis nonclinical LC-MS BA/TK studies, qualification of BA/TK ESPs, study conduct and completion, ESP oversight and evaluation, issue mitigation, and future perspectives.

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Diclofenac sodium salt (DSS) is a widely used nonsteroidal anti-inflammatory drug. The present study was performed under good laboratory practice (GLP) regulations to investigate the toxicity of DSS after 4 weeks of repeated intramuscular administration at doses of 0, 2, 10, or 20 mg/kg/day in 32 minipigs and to evaluate the DSS effect following a 2-week recovery period. Dose-related clinical signs and alterations of hematological or clinical chemistry parameters, organ weight, and macroscopic as well as histopathological findings in hepatic, renal, gastrointestinal, skin and injection sites were observed in both sexes' animals of the 10 or 20 mg/kg/day group. With the exception of the skin-related findings, most symptoms showed a tendency to resolve after the 2-week recovery period. The systemic exposure (AUClast) of DSS in plasma showed similar pattern to the increase rate of the dose and similar values between males and females except for the female 20 mg/kg dose group (56 %) on Day1. The systemic exposure showed a decreasing trend in the 10 or 20 mg/kg group after 4-week of repeated administration compared to Day1. The no-observed-adverse-effect level of DSS in this study was considered to be 2 mg/kg/day in both male and female minipigs.

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Objective:To explore the collaborative development of drug clinical trial institutions and Contract Research Organizations from the perspective of " government-application-industry-academia-research" , and facilitate faster and better conducting of clinical trials.Methods:Based the combination of literature review and the working practice in drug clinical trial management, problems existed during the implementation of clinical trials were summarized, and then the collaborative development of drug clinical trial institutions and Contract Research Organizations were discussed from the perspective of " government-application-industry-academia-research" partnership.Results:Problems identified during the implementation of clinical trials including uneven capacity of CROs, lack of effective supervision department and insufficient cooperation with clinical trial institutions, which resulted difficulties in sharing clinical trial resources and also negatively impacted the quality of clinical trials. Some proposals were offered in this article, including making good use of the " visible hand" of the government to strengthen the supervision of CROs, accelerating the construction of innovation alliance between clinical trial institutions and CROs, establishing the incentive mechanism of collaborative development and the talent team construction, strengthening the personnel professional training.Conclusions:The application of " government-application-industry-academia-research" model in clinical trials would promote the collaboration between drug clinical trial institutions and Contract Research Organizations, which play important roles in the development of clinical trials.

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RATIONALE AND OBJECTIVES: Participation in clinical research can be both highly rewarding and logistically demanding. As highlighted by recent Food and Drug Administration guidance, imaging has become an integral part of this research. The unique technical and administrative aspects of clinical trial imaging may differ substantially from those of standard-of-care imaging and thus burden the established clinical infrastructure at investigational sites. Failure to comply with requirements can lead to unusable data, repeat imaging, or the removal of patients from the trial. It is therefore imperative that all stakeholders address these challenges to engage in clinical research successfully. MATERIALS AND METHODS: The authors' experiences in managing clinical trial imaging requirements at their institution were used to identify common challenges. The impact of these challenges was assessed from an operational perspective. RESULTS: Although contract research organizations attempt to minimize these challenges, their efforts are necessarily limited and insufficient, and there is a lack of infrastructure available at investigational sites to address these issues. As such, recommendations are proposed for addressing these challenges at institutional and industry levels. CONCLUSION: The challenges associated with clinical trial imaging require an investment of resources from all stakeholders. Investigational sites must confront these challenges to satisfy trial requirements effectively, maintain a superior level of patient care, and guarantee trial integrity. Similarly, sponsors must acknowledge the burden of clinical trial imaging and support the development of the necessary local infrastructure. The implementation of the recommendations described here will improve the conduct of clinical trial imaging.

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The Clinical Trials Transformation Initiative (CTTI) Strengthening the Investigator Community Project was prompted by the need to understand the reasons for high rates of turnover among investigators who lead US Food and Administration-regulated clinical trials at research sites. Because investigator knowledge and experience directly affect the quality and ultimate success of clinical trials, investigator turnover has important implications for the research enterprise, as well as the patients and other stakeholders who depend on the outcomes of clinical research. The CTTI project team used findings from both quantitative and qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to delineate key concerns faced by investigators and recommend practical, action-based solutions. The recommendations focus on strengthening four key categories of site-based research activity: developing site-based research infrastructure and staff, optimizing trial execution and conduct, improving site budget development and contract negotiations, and discovering opportunities for conducting additional trials.

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The progressive changes in research paradigms observed in the largest pharmaceutical companies and the burgeoning of biotechnology startups over the last 10 years have generated a need for outsourcing research facilities. In parallel, progress made in the fields of genomics, protein expression in recombinant systems, and electrophysiological recording methods have offered new possibilities for the development of contract research organizations (CROs). Successful partnering between pharmaceutical companies and CROs largely depends upon the competences and scientific quality on offer for the discovery of novel active molecules and targets. Thus, it is critical to review the knowledge in the field of neuroscience research, how genetic approaches are augmenting our knowledge, and how they can be applied in the translation from the identification of potential molecules up to the first clinical trials. Taking these together, it is apparent that CROs have an important role to play in the neuroscience of drug discovery.
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Los cambios progresivos en los paradigmas de investigación observados en las principales compañías farmacéuticas y el desarrollo de las nuevas empresas de biotecnología en los últimos 10 años han generado la necesidad de subcontratar las instalaciones de investigación. Paralelamente, el progreso realizado en los campos de la genómica, la expresión de proteínas en sistemas recombinantes y en los métodos de registro electrofisiológico han ofrecido nuevas posibilidades para el desarrollo de organizaciones de investigación por contrato (OIC). La asociación exitosa entre las compañías farmacéuticas y las OIC depende en gran medida de las competencias y la calidad científica que se ofrecen para el descubrimiento de nuevas moléculas activas y sitios de acción. Por lo tanto, es fundamental revisar el conocimiento en el campo de la investigación en neurociencia, cómo las aproximaciones genéticas están aumentando nuestro conocimiento y cómo se pueden aplicar en la traducción desde la identificación de potenciales moléculas hasta los ensayos clínicos iniciales. Tomando esto en conjunto, es evidente que las OIC tienen un papel importante que desempeñar en la neurociencia del descubrimiento de fármacos.

Les modifications observées durant les dix dernières années concernant les modèles organisationnels des grandes industries pharmaceutiques ainsi que la multiplication des entreprises de biotechnologies ont augmentés les besoins de recherches dans des laboratoires privés. En parallèle les progrès en génomique ainsi que dans les systèmes d'expression de protéines recombinantes ont ouvert de nouvelles possibilités pour le développement d'unités indépendantes qui offrent de la recherche sous contrats (CRO). Le succès des recherches distribuées entre partenaires pharmaceutiques et les unités de recherche privées dépend essentiellement des compétences ainsi que des qualités scientifiques qui peuvent être offertes pour la découverte de nouvelles molécules agissant sur une cible définie. Il est important d'examiner, comment les nouvelles découvertes effectuées dans le domaine de la génétique et l'accroissement de nos connaissances, peuvent se traduire dans l'identification de nouvelles molécules à visée thérapeutiques depuis la recherche fondamentale jusqu'aux essais cliniques. D'une manière globale, il apparaît que les unités de recherche contractuelles ont un rôle majeur à jouer dans le domaine de la recherche en neuroscience ainsi que dans la découverte de nouveaux principes actifs.

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A wide range of career options is available globally in the environmental toxicologic pathology (ETP) arena including academia, government, contract research organizations, and the agrichemical/chemical industry. This small and specialized subset of toxicologic pathologists addresses the effects of contaminants and pollutants on human, animal, and ecological health (One Health). Veterinary students and pathology trainees are primarily exposed to diagnostic pathology and often have limited exposure to toxicologic pathology and even less so to the issues and opportunities in environmental toxicology. The speakers provided a brief overview of global opportunities in their work sector and personal perspectives of their careers in ETP. The following panel discussion provided an opportunity to discuss issues related to careers in this specialty.

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With the growth in co-development deals between pharmaceutical companies and the increased use of contract research organizations (CROs) in drug development, more and more employees are encountering projects that require working across different companies. Navigating the mix of corporate cultures as well as variations in standards and procedures can lead to unanticipated challenges and delays. The development of ertugliflozin, a recently approved medicine for type 2 diabetes mellitus, involved both co-development and CRO engagement across 4 companies. Challenges to combining processes and systems across the 4 companies were encountered and resolved. Early decisions for adoption of standards and processes as well as the organization of committees and communication pathways were key to the success of this ambitious program. Here we share our experiences and lessons learned with respect to the analysis and reporting of clinical trial results.

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A large number of CNS safety assessment studies using the standard Functional Observational Battery (FOB) are conducted each year at Contract Research Organizations throughout the globe. Study design characteristics are as varied as the Sponsors for whom they are contracted. Gender inclusion, sample sizes, and timing of the FOBs are generally negotiated during protocol development. The ICH S7A guidelines describe a dose-effect study design for CNS safety assessment to be conducted prior to the first dose administration in man. Additionally, some Sponsors attempt to use the CNS safety FOB to establish both time- and dose-related acute behavioral effects of their compound in this single critical safety study. In this review, we highlight the confounding influences of multiple postdose FOBs (Day 1) versus the more standard, single FOB scheduled near systemic Cmax of the compound. Within- and between-session learning, combined with changes in vigilance/alertness/fatigue in both the animals and raters, can limit the generalizability of the FOB to accurately assess CNS effects under the current guidelines. Rationale is provided as to the tenuous nature of conducting simultaneous time- and dose-effect behavioral assessments as part of the core safety pharmacology programs.

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BACKGROUND: The use of smart and/or wearable devices for collection of electronic data in clinical trials has recently become a strong tool with which to collect patients' data in a timely manner. Electronic collection of patient data will necessitate comprehensive data analysis involving huge-scale datasets in the future. However, it is still unclear how to validate and qualify computerized systems used to collect and/or manage electronic clinical data when smart and/or wearable devices are involved. METHODS: We (a special interest group of Good Automated Manufacturing Practice Japan Forum [GAMP Japan]) investigated and designed a data-flow model for a clinical data management system involving smart and/or wearable devices, and suggested an approach for the validation of such a computerized system. The appropriateness of applying GAMP5 to the validation of a clinical data management system involving smart and/or wearable devices was also reviewed. RESULTS: A regulated company should have policies and standard procedures for validating computerized systems in clinical systems. When a sponsor engages a contract research organization (CRO) for clinical data management, the sponsor should assess the CRO to confirm their capabilities. The sponsor also needs to check whether the CRO assesses device manufacturers as sub-suppliers. When the CRO intends to conduct sub-supplier assessment with a device manufacturer, a risk-based approach can be taken. CONCLUSIONS: We believe our method of system validation will be applicable to and will facilitate various clinical trials that involve smart and/or wearable devices.