A Successful Gap-Year Clinical Research Technician (CRT) Program at an Academic Anesthesiology Department.

BACKGROUND: Many students elect to take gap years in between graduating college and matriculating into medical school. At an academic institution, investigators can be limited in conducting research due to clinical endeavors. Utilizing a structured, clinical research, gap-year program with students called clinical research technicians (CRTs) can aid both investigators conducting research and students applying to graduate health programs. In this original article, we sought to understand CRT and investigator perceptions of and experiences in the program. METHODS: We distributed a survey to past and present CRTs and the investigators with whom they worked at Atrium Health Wake Forest Baptist Medical Center. We conducted thematic and sentiment analyses of the survey results. We also collected data on grant approvals, research funding awards, and CRT, clinical research nurse, and clinical research coordinator salaries. RESULTS: We received responses from 20/29 investigators and 21/22 CRTs. We identified five themes for the investigator survey, including research accuracy and precision; research output; alleviating responsibilities; cost; and likelihood of referral. We identified five themes for the CRT survey, including future career assistance; physician career insights; mentorship; likelihood of referral; and other. The majority of respondents strongly agreed or agreed with the survey statements. The majority of comments were coded as positive. All of CRTs were accepted into a graduate health profession program. CONCLUSIONS:  Our program's success demonstrates how a structured, clinical research, gap-year program for premedical students can serve as a new educational tool and important research infrastructure resource for hospitals.

Promoting validation and cross-phylogenetic integration in model organism research.

Model organism (MO) research provides a basic understanding of biology and disease due to the evolutionary conservation of the molecular and cellular language of life. MOs have been used to identify and understand the function of orthologous genes, proteins, cells and tissues involved in biological processes, to develop and evaluate techniques and methods, and to perform whole-organism-based chemical screens to test drug efficacy and toxicity. However, a growing richness of datasets and the rising power of computation raise an important question: How do we maximize the value of MOs? In-depth discussions in over 50 virtual presentations organized by the National Institutes of Health across more than 10 weeks yielded important suggestions for improving the rigor, validation, reproducibility and translatability of MO research. The effort clarified challenges and opportunities for developing and integrating tools and resources. Maintenance of critical existing infrastructure and the implementation of suggested improvements will play important roles in maintaining productivity and facilitating the validation of animal models of human biology and disease.

Management strategies for implementing a multicenter cross-sectional study: lessons from the ADHERE Brazil study

ABSTRACT BACKGROUND: Epidemiological studies involving large samples usually face financial and operational challenges. OBJECTIVES: To describe the planning and execution of ADHERE Brazil, an epidemiological study on 1,105 kidney transplant patients, and report on how the study was structured, difficulties faced and solutions found. DESIGN AND SETTING: Cross-sectional multicenter study in 20 Brazilian kidney transplantation centers. METHODS: Actions developed in each phase of implementation were described, with emphasis on innovations used within the logistics of this study, aimed at estimating the prevalence of nonadherence to treatment. RESULTS: Coordination of activities was divided into four areas: general, regulatory, data collection and statistics. Weekly meetings were held for action planning. The general coordination team was in charge of project elaboration, choice of participating centers, definition of publication policy and monitoring other coordination teams. The regulatory team provided support to centers for submitting the project to ethics committees. The data collection team prepared a manual on the electronic collection system, scheduled web meetings and was available to respond to queries. It also monitored the data quality and reported any inadequacies found. Communication with the centers was through monthly reports via e-mail and distribution of exclusive material. The statistical team acted in all phases of the study, especially in creating the data analysis plan and data bank, generation of randomization lists and data extraction. CONCLUSIONS: Through these logistics, we collected high-quality data and built a local research infrastructure for further studies. We present supporting alternatives for conducting similar studies. CLINICAL TRIAL ANNOTATION: http://clinicaltrials.gov/ on October 10, 2013; NCT02066935.

The European & Developing Countries Clinical Trials Partnership (EDCTP) Knowledge Hub: developing an open platform for facilitating high-quality clinical research.

There is stark global inequity in health research in terms of where studies happen, who leads the research and the ultimate beneficiaries of the results generated. Despite significant efforts made, limited research ideas are conceptualised and implemented in low-resource settings to tackle diseases of poverty, and this is especially true in sub-Saharan Africa. There is strong evidence to show that the barriers to locally led research do not vary largely between disease, study type and location and can be largely solved by addressing these common gaps. The European & Developing Countries Clinical Trials Partnership (EDCTP) was established in 2003 as a European response to the global health crisis caused by the three main poverty-related diseases HIV, tuberculosis and malaria. EDCTP has established a model of long-term sustainable capacity development integrated into clinical trials which addresses this lack of locally led research in sub-Saharan Africa, supporting the development of individual and institutional capacity and research outputs that change the management, prevention and treatment of poverty-related and neglected infectious diseases across Africa. In recognition of emergent data on what the barriers and enablers are to long-term, sustainable capabilities to run studies, EDCTP formed a new collaboration with The Global Health Network (TGHN) in September 2017, with the aim to make a set of cross-cutting tools and resources to support the planning, writing and delivery of high-quality clinical trials available to research staff wherever they are in the world, especially those in low- and middle-income countries (LMICs) via TGHN platform. These new resources developed on the 'EDCTP Knowledge Hub' are those identified in the mixed method study described in this commentary as being key to addressing the gaps that the research community report as the most limiting elements in their ability to design and implement studies. The Knowledge Hub aims to make these tools freely available to any potential health research team in need of support and guidance in designing and running their own studies, particularly in low-resource settings. The purpose is to provide open access to the specific guidance, information and tools these teams cannot otherwise access freely. Ultimately, this will enable them to design and lead their own high-quality studies addressing local priorities with global alignment, generating new data that can change health outcomes in their communities.

Maximizing Shared Research Resources: Next Steps.

Shared research resources (SRRs) promote access and training to advanced technologies and applications for a diverse array of trainees, faculty, students, and staff. Institutions and the broader research community benefit from the expertise and reputation of SRRs, their efficient use of research funds, and their positive impact on faculty recruitment and retention. Moreover, as contemporary science has become increasingly multidisciplinary and team based, SRRs are the nexus for basic discovery and the application of new groundbreaking technologies, with data as the key deliverable. However, despite their track record of accomplishments, barriers continue to exist, hindering SRRs essential role in modern research and highlighting the need for a national strategy to ensure their sustainability. The recommendations from the Federation of American Societies for Experimental Biology (FASEB) SRR Task Force publication "Maximizing SRR part III" and subsequent roundtable meetings have spurred efforts for strengthening shared resources, achieving career recognition and parity, and elevating team science to its full potential. This JBT special issue focuses on these efforts, with contributions from members of the Association of Biomolecular Resource Facilities and FASEB Task Force.

A Shift in Our Thinking: Reframing Shared Research Resources as Investments in Education and Innovation, Not Subsidized Science.

For many researchers, Shared Research Resources are often the most cost-effective means of using state-of-the-art (not to mention expensive) instrumentation. Along with access to the instruments themselves, Shared Research Resources also offer individualized training by highly qualified Shared Research Resource staff-again at deeply discounted costs compared to the operational costs of the facilities. Traditionally, this gap in revenue has been termed a subsidy. But, as with many words, connotation matters, and we posit that this language ought to be changed to reframe our thinking and impart the true impact of Shared Research Resources. We argue here that rather than a subsidy, the revenue gap is better described as an investment. Furthermore, investments of Shared Research Resources lead to positive externalities, including education and innovation.

Research for the Future: An Overview of the FASEB Shared Research Resources Task Force's Finding and Recommendations.

The Federation of American Societies for Experimental Biology (FASEB) is composed of 28 member societies, representing over 115,000 individual scientists, including the Association of Biomedical Research Facilities and its members. As part of FASEB's mission to advance awareness and support of biological and biomedical research, the Federation remains committed to sustaining support for the resources that investigators use to conduct rigorous research. This includes shared resources and the core facility staff that enable researchers to have widespread access to state-of-the art technologies and expertise. Recognizing the fundamental role of shared resources in driving biomedical research progress, FASEB established the Shared Research Resources Task Force in June 2020 to discuss ongoing policy challenges related to shared resources and core facilities and identify ways to enhance their recognition and sustainability within the research enterprise. In addition to publishing a report outlining its final recommendations, the Task Force hosted a Virtual Roundtable with external stakeholders to exchange ideas and best practices about strengthening shared resources and elevating team science to its full potential. Taken together, these efforts demonstrate a key initial step toward addressing long-standing challenges and advancing shared priorities.

Preclinical Models and Resources to Facilitate Basic Science Research on Malignant Mesothelioma - A Review.

Malignant mesothelioma is an aggressive cancer with poor prognosis, predominantly caused by human occupational exposure to asbestos. The global incidence of mesothelioma is predicted to increase as a consequence of continued exposure to asbestos from a variety of sources, including construction material produced in the past in developed countries, as well as those currently being produced in developing countries. Mesothelioma typically develops after a long latency period and consequently it is often diagnosed in the clinic at an advanced stage, at which point standard care of treatment, such as chemo- and radio-therapy, are largely ineffective. Much of our current understanding of mesothelioma biology, particularly in relation to disease pathogenesis, diagnosis and treatment, can be attributed to decades of preclinical basic science research. Given the postulated rising incidence in mesothelioma cases and the limitations of current diagnostic and treatment options, continued preclinical research into mesothelioma is urgently needed. The ever-evolving landscape of preclinical models and laboratory technology available to researchers have made it possible to study human disease with greater precision and at an accelerated rate. In this review article we provide an overview of the various resources that can be exploited to facilitate an enhanced understanding of mesothelioma biology and their applications to research aimed to improve the diagnosis and treatment of mesothelioma. These resources include cell lines, animal models, mesothelioma-specific biobanks and modern laboratory techniques/technologies. Given that different preclinical models and laboratory technologies have varying limitations and applications, they must be selected carefully with respect to the intended objectives of the experiments. This review therefore aims to provide a comprehensive overview of the various preclinical models and technologies with respect to their advantages and limitations. Finally, we will detail about a highly valuable preclinical laboratory resource to curate high quality mesothelioma biospecimens for research; the biobank. Collectively, these resources are essential to the continued advancement of precision medicine to curtail the increasing health burden caused by malignant mesothelioma.

Prioritisation and design of clinical trials.

Clinical trials require participation of numerous patients, enormous research resources and substantial public funding. Time-consuming trials lead to delayed implementation of beneficial interventions and to reduced benefit to patients. This manuscript discusses two methods for the allocation of research resources and reviews a framework for prioritisation and design of clinical trials. The traditional error-driven approach of clinical trial design controls for type I and II errors. However, controlling for those statistical errors has limited relevance to policy makers. Therefore, this error-driven approach can be inefficient, waste research resources and lead to research with limited impact on daily practice. The novel value-driven approach assesses the currently available evidence and focuses on designing clinical trials that directly inform policy and treatment decisions. Estimating the net value of collecting further information, prior to undertaking a trial, informs a decision maker whether a clinical or health policy decision can be made with current information or if collection of extra evidence is justified. Additionally, estimating the net value of new information guides study design, data collection choices, and sample size estimation. The value-driven approach ensures the efficient use of research resources, reduces unnecessary burden to trial participants, and accelerates implementation of beneficial healthcare interventions.

Integrating the resources of Korean disaster management research via the Johari window.

It is not widely known that quite a few researchers are faced with difficulties in using various resources of disaster management research in Korea. The article aims to assess how rigorously the Korean field of disaster management research resources has been managed or how it can be improved for the ultimate goal of disaster management. Descriptive content analysis has been used as the major methodology by referring to the Johari window. In doing so, electronic research resources have been systematically compared with integrated research resources via the perspective of Korean-speaking researchers and that of English-speaking researchers. The conclusion is that two researchers have to be integrated with all four research resources (open, blind, hidden, and unknown resources) by implementing assigned responsibilities as well as freely asking questions. Ultimately, this will be conducive to reducing down the impacts of disaster in Korea.

Journey to Now: The Origins of ABRF.

The development and expansion of the core facility concept are <4 decades old. The factors that favored the use of shared instrumentation facilities and the requirement for expert staff are covered by one of the founders of the Association of Biomolecular Resource Facilities (ABRF). During the decade when grants for shared instruments and the release of modern, automated instruments flourished, protocol development for those new instruments came primarily out of laboratories of the type we now call core facilities. Because of the new technologies available, new protocols were required to meet the needs of research communities, and much of the development took place in the diverse core facilities. Furthermore, technology development itself was a frequent activity in core facilities. Although guidelines for the operation of core facilities were not available in the early days of core facility operation, they evolved over time. Cost recovery was, and is still, one of the most problematic issues for core facilities. ABRF-supported research groups offered members opportunities to evaluate their capabilities with both lab-developed protocols and study-specified protocols and with comparative data collected in surveys of core facilities. Research groups are a premier activity of ABRF and its members. More new developing technologies have followed using this pattern of collaboration among core facilities and with industry. The exhibition floor at ABRF annual meetings shows off many of the results of these collaborations.

Exploring Professional Development for New Investigators Underrepresented in the Federally Funded Biomedical Research Workforce.

Objective: The National Research Mentoring Network (NRMN) is a strategic partnership whose goals include remedying documented disparities by race and ethnicity in the awarding of National Institutes of Health research grants. Our objectives were to offer a profile of early-career investigators who applied to NRMN's Grantsmanship Coaching Programs (GCP) and test for differences in the research productivity, professional obligations, research resources, and motivations of applicants from underrepresented groups (URGs) compared with applicants from well-represented groups (WRGs). We also evaluated how employment at a minority serving institution (MSI) influenced access to research resources and professional obligations. Participants: 880 investigators who submitted online applications to join an NRMN GCP between August 1, 2015 and February 1, 2018. Methods: We used two-sample tests of proportions and logistic regression to explore differences in applicants' characteristics and local research environment by group (URG vs WRG) and institution type (MSI vs Other). Results: URG and WRG applicants did not differ in grant application submission history. However, URG applicants had published fewer articles than WRG peers (9.8 vs 15.3, P<.001) and fewer articles as first/last author (4.4 vs 6.9, P<.001). URG applicants reported less access to core facilities to conduct research (74% vs 81%, P<.05). Investigators at MSIs reported less access to collaborators (P<.01) and departmental colleagues with federal funding (P<.001) and spent less time on conducting research (P<.001). URGs were more motivated to seek professional development support to expand their peer networks (P<.05) and advance their careers (P<.001). Conclusions: Our findings identified several points of intervention to help applicants from URGs to improve their future chances of obtaining competitive funding.

European mental health research resources: Picture and recommendations of the ROAMER project.

As part of the Roamer project, we sought to have a picture of the available mental health research (MHR) funding, capacity-building and infrastructures resources and to establish consensus-based recommendations that would allow an increase of European MHR resources and enable better use and accessibility to them. The methods fell into three sections (i) a review of the literature, (ii) a mental health-related keywords search within the Cordis®, On-Course® and Meril® databases which contain information on European research funding, training and infrastructures. These reviews provided an overview that was presented to (iii) two experts workshops with 28 participants drawn from academic which identified gaps and produced recommendations. The literature review illustrates the debates in the scientific community on funding, training and infrastructures. The database searches estimated the fraction of health research resources available for mental health. Eight overarching goals for MHR resources were identified by the workshops; each of them was carried out with several practical recommendations. Resources for MHR are scarce considering the burden of mental disorders, the high rate of return of MHR and the under-investment of the field. The recommendations are urgently warranted to increase resources and their optimal access and use.

The Resource Identification Initiative: A Cultural Shift in Publishing.

A central tenet in support of research reproducibility is the ability to uniquely identify research resources, i.e., reagents, tools, and materials that are used to perform experiments. However, current reporting practices for research resources are insufficient to identify the exact resources that are reported or to answer basic questions such as "How did other studies use resource X?" To address this issue, the Resource Identification Initiative was launched as a pilot project to improve the reporting standards for research resources in the Methods sections of articles and thereby improve identifiability and scientific reproducibility. The pilot engaged over 25 biomedical journal editors from most major publishers, as well as scientists and funding officials. Authors were asked to include Research Resource Identifiers (RRIDs) in their articles prior to publication for three resource types: antibodies, model organisms, and tools (i.e., software and databases). RRIDs are assigned by an authoritative database, for example, a model organism database for each type of resource. To make it easier for authors to obtain RRIDs, resources were aggregated from the appropriate databases and their RRIDs made available in a central Web portal (http://scicrunch.org/resources). RRIDs meet three key criteria: they are machine-readable, free to generate and access, and are consistent across publishers and journals. The pilot was launched in February of 2014 and over 300 articles have appeared that report RRIDs. The number of journals participating has expanded from the original 25 to more than 40, with RRIDs appearing in 62 different journals to date. Here we present an overview of the pilot project and its outcomes to date. We show that authors are able to identify resources and are supportive of the goals of the project. Identifiability of the resources post-pilot showed a dramatic improvement for all three resource types, suggesting that the project has had a significant impact on identifiability of research resources.

La investigación en instituciones de salud de mediana y alta complejidad del Valle de Aburrá, 2011 / Research in Mid and High Complexity Healthcare Facilities in the Aburra Valley, 2011 / A pesquisa em institutes de saúde de mediana e alta complexidade do Valle de Aburrá, 2011

Objetivo: identificar el nivel de conocimiento de los empleados acerca de las políticas de investigación en las instituciones de salud de mediana y alta complejidad en el Valle de Aburrá, Colombia. Metodología: investigación de corte transversal, con aplicación de encuestas a 224 empleados en las instituciones prestadoras de servicios salud de alta (52) y mediana complejidad (322), públicas y privadas en el 2011. Resultados: en referencia al conocimiento de la existencia de políticas de investigación, se encontró que este es mayor en los empleados de las instituciones de alta complejidad (p=0,000). Más del 70% de los empleados encuestados manifestaron su interés en trabajar en proyectos de investigación. Conclusión: las instituciones de salud de alta complejidad y públicas tuvieron más desarrollos en investigación y se percibió gran interés por la investigación en los empleados del sector salud, con independencia del nivel de complejidad, del tipo de institución y del nivel de formación.

Objective: identifying the knowledge level of the employees regarding the research policies of mid and high complexity healthcare facilities in the Aburra Valley, Colombia. Methodology: cross-section research, with surveys for 224 employees of the healthcare providing institutions of high (52) and mid (322) complexity, both public and private, in 2011. Results: regarding the knowledge about the existence of research policies, we found that it is higher in the employees of high complexity institutions (p = 0.000). Over 70% of the employees surveyed showed their interest in working on research projects. Conclusion: public high complexity healthcare facilities showed more developments on research and we found great interest of the employees of the health sector on research, regardless of the complexity level, the type of facility, and education level.

Objetivo: identificar o nivel de conhecimento dos empregados sobre as políticas de pesquisa nas instituicoes de saúde de mediana e alta complexidade no Valle de Aburrá, Colombia. Metodologia: pesquisa de corte transversal, com aplicação de inquéritos a 224 empregados de instituicoes prestadoras de servicos de saúde de alta (52) e mediana complexidade (322), públicas e privadas no ano 2011. Resultados: no que diz respeito do conhecimento sobre a existencia de políticas de pesquisa, encontrou-se que é maior em empregados de instituicoes de alta complexidade (p = 0,000). Mais de 70 % dos empregados indagados manifestaram interesse por trabalhar em projetos de pesquisa. Conclusão: as instituicoes de saúde de alta complexidade públicas tiveram maior desenvolvimento de pesquisa e percebeu-se grande interesse dos empregados do sector saúde pela pesquisa, com independencia do nível de complexidade, do tipo de instituicao e do nível de formação.

Research on the clinical and translational science awards of The National Institutes of Health / 中华医学科研管理杂志

Translational medicine is a more effective and efficient way to improve the investment return on bioscience and provide equitable access to high—quality healthcare.Recognizing the need for a new impetus to spur clinical and translational research,the National Institutes of Health established the Clinical and Translational Science Awards Program.

Outcomes research resources in India: current status, need and way forward.

BACKGROUND: Despite their importance, the number of outcomes research studies conducted in India are lesser than other countries. Information about the distribution of existing outcomes research resources and relevant expertise can benefit researchers and research groups interested in conducting outcomes research studies and policy makers interested in funding outcomes research studies in India. We have reviewed the literature to identify and map resources described in outcomes research studies conducted in India. METHODS: We reviewed the following online biomedical databases: Pubmed, SCIRUS, CINAHL, and Google scholar and selected articles that met the following criteria: published in English, conducted on Indian population, providing information about outcomes research resources (databases/registries/electronic medical records/electronic healthcare records/hospital information systems) in India and articles describing outcomes research studies or epidemiological studies based on outcomes research resources. After shortlisting articles, we abstracted data into three datasets viz. 1. Resource dataset, 2. Bibliometric dataset and 3. Researcher dataset and carried out descriptive analysis. RESULTS: Of the 126 articles retrieved, 119 articles were selected for inclusion in the study. The tally increased to 133 articles after a secondary search. Based on the information available in the articles, we identified a total of 91 unique research resources. We observed that most of the resources were Registries (62/91) and Databases ( 23/91) and were primarily located in Maharashtra (19/91) followed by Tamil Nadu (11/91), Chandigarh (8/91) and Kerala (7/91) States. These resources primarily collected data on Cancer (44/91), Stroke (5/91) and Diabetes (4/91). Most of these resources were Institutional (38/91) and Regional resources (35/91) located in Government owned and managed Academic Institutes/Hospitals (57/91) or Privately owned and managed non - Academic Institutes/Hospitals (14/91). Data from the Population based Cancer Registry, Mumbai was used in 41 peer reviewed publications followed by Population based Cancer Registry, Chennai (17) and Rural Cancer Registry Barshi (14). Most of the articles were published in International journals (139/193) that had an impact factor of 0-1.99 (43/91) and received an average of 0-20 citations (55/91). We identified 193 researchers who are mainly located in Maharashtra (37/193) and Tamil Nadu (24/193) states and Southern (76/193) and Western zones (47/193). They were mainly affiliated to Government owned & managed Academic Institutes /Hospitals (96/193) or privately owned and managed Academic Institutes/ Hospitals (35/193). CONCLUSIONS: Given the importance of Outcomes research, relevant resources should be supported and encouraged which would help in the generation of important healthcare data that can guide health and research policy. Clarity about the distribution of outcomes research resources can facilitate future resource and funding allocation decisions for policy makers as well as help them measure research performance over time.

Epidemiological and phylogenetic analysis of institutional mouse parvoviruses.

Mouse parvoviruses (MPVs) are small, single-stranded, 5 kb DNA viruses that are subclinical and endemic in many laboratory mouse colonies. MPVs cause more distinctive deleterious effects in immune-compromised or genetically-engineered mice than immuno-competent mice. At the University of Louisville (U of L), there was an unexpected increase of MPV sero-positivity for MPV infections in mouse colonies between January 2006 and February 2007, resulting in strategic husbandry changes aimed at controlling MPV spread throughout the animal facility. To investigate these MPVs, VP2 genes of seven MPVs were cloned and sequenced from eight documented incidences by PCR technology. The mutations in these VP2 genes were compared to those found at the Genbank database (NCBI; http://www.ncbi.nlm.nih.gov) and an intra-institutional phylogenetic tree for MPV infections at U of L was constructed. We discovered that the seven MPV isolates were different from those in Genbank and were not identical to each other. These MPVs were designated MPV-UL1 to 7; none of them were minute virus of mice (MVMs). Four isolates could be classified as MPV1, one was classified as MPV2, and two were defined as novel types with less than 96% and 94% homology with existing MPV types. Considering that all seven isolates had mutations in their VP2 genes and no mutations were observed in VP2 genes of MPV during a four-month time period of incubation, we concluded that all seven MPVs isolated at U of L between 2006 and 2007 probably originated from different sources. Serological survey for MPV infections verified that each MPV outbreak was controlled without further contamination within the institution.

Thoughts on establishing Shanghai Academy of Medical Sciences / 中华医学科研管理杂志

The authors discussed about how to integrate the advantages of different medical research resources to construct Shanghai Academy of Medical Sciences,which will provide substantial support for medical innovation in Shanghai.Principles were proposed concerning the administrative system and management mechanism to enhance the performance.The Academy is expected to improve medical research and clinical performance,especially to help resolve some major diseases and incurable diseases.Ultimately,the Academy will develop into an advanced research center linking laboratory research and clinical medicine.