Basic principles of biobanking: from biological samples to precision medicine for patients.

The term "biobanking" is often misapplied to any collection of human biological materials (biospecimens) regardless of requirements related to ethical and legal issues or the standardization of different processes involved in tissue collection. A proper definition of biobanks is large collections of biospecimens linked to relevant personal and health information (health records, family history, lifestyle, genetic information) that are held predominantly for use in health and medical research. In addition, the International Organization for Standardization, in illustrating the requirements for biobanking (ISO 20387:2018), stresses the concept of biobanks being legal entities driving the process of acquisition and storage together with some or all of the activities related to collection, preparation, preservation, testing, analysing and distributing defined biological material as well as related information and data. In this review article, we aim to discuss the basic principles of biobanking, spanning from definitions to classification systems, standardization processes and documents, sustainability and ethical and legal requirements. We also deal with emerging specimens that are currently being generated and shaping the so-called next-generation biobanking, and we provide pragmatic examples of cancer-associated biobanking by discussing the process behind the construction of a biobank and the infrastructures supporting the implementation of biobanking in scientific research.

Indicators of Evaluating Research at Article Level: Recommendation for Effective Evaluation of APJCP' Scientific Performances

Today, research is seen as an investment to promote innovation and maintain sustainable social-economic development in all societies. The growth of scientific products and the expansion of knowledge in different scientific fields have entailed more attention to assessments and the impact evaluation of both outcome and process of researchers in all fields. In light of this need, policymakers in the medical field have paid more attention to evaluating the outcomes of research in terms of its impact on the society using many different indicators. In this short communication, the performance of scholarly published scientific products are discussed and the indicators that measure such impacts are evaluated and recommendation is given to APJCP' editorial board on how to align its activities toward achieving better impact and scientometric measures for the journal.

¿Por qué la mayoría de la investigación clínica no es útil? / Why most clinical research is not useful?

En este ensayo, el autor reflexiona sobre la relevancia de las investigaciones clínicas que se desarrollan con frecuencia en la actualidad. Destaca que a diferencia de la "investigación creativa, especulativa o basada en la curiosidad" (blue-sky research), que no puede ser juzgada directamente en base al impacto práctico, la investigación clínica debería ser útil: es decir, hacer una diferencia para la salud de los pacientes, o ser realizada con una perspectiva realista. Para ello realiza algunas propuestas de mejora, como ser; una correcta justificación y puesta en contexto del problema en estudio, procurar una adecuada ganancia de información, pragmatismo, estar centrada en los pacientes, ser viable, con una adecuada relación precio-calidad y transparente. Muchos estudios, aún en la mayoría de las revistas médicas generales, no satisfacen ninguna de estas características, y muy pocos satisfacen la mayoría o todas ellas. Gran parte de la investigación falla en su utilidad no por sus hallazgos, sino por su diseño. Por otro lado, el autor sostiene que las fuerzas que guían la producción y diseminación de investigación clínica inútil son claramente identificables y modificables. Se necesita una reforma. Alterar nuestro abordaje podría producir fácilmente más investigación clínica útil y, al mismo tiempo, de menor costo. (AU)

In this essay, the author reflects on the relevance of today's clinical research. Stresses that unlike blue-sky research, which can not be judged directly based on practical impact, clinical research should be useful: that is, make a difference to the health of patients, or be carried out with a realistic perspective. Proposed key features of clinical investigation to achieve that are: problem based, context placement, information gain, pragmatism, patient centered, value for money, feasibility and transparency. Many studies, even those published in core clinical journals, do not satisfy any of these characteristics, and very few satisfy most or all of them. Most research fails in its utility not because of its findings, but because of its design. On the other hand, the author argues that the forces that guide the production and dissemination of useless clinical research are clearly identifiable and modifiable. A reform is needed. Altering our approach could easily produce more useful clinical research and, at the same time, with lower cost. (AU)

[The top ten researches of Chinese ocular trauma research in recent five years].

Ten researches that may represent the progress in Chinese ocular trauma related studies were selected through voting by specialists from Chinese Ocular Trauma Society. These researches focused on the following fields: new strategies for the treatment of ocular trauma, study of vitreoretinal surgery and new technique application for severe ocular trauma, establishment of animal modal for basic research of ocular trauma, prevention of infectious endophthalmitis, clinical and basic study of ocular chemical burn, establishment of the public service and research platform of ocular trauma. These studies represented the level and influence of Chinese ocular trauma specialists in the international academic community and they were the landmark studies of our areas of expertise.

[The top ten researches of Chinese oculoplastic surgery and orbital disease in recent five years].

Ten researches that may represent the progress in Chinese oculoplastic surgery and orbital disease were selected through voting by specialists from Chinese Society of Ophthalmic Plastics and Orbital Disease. These researches focused on the following fields: the endoscopic navigation system of orbital surgery, orbital bone regeneration and materials, comprehensive sequence treatment of retinoblastoma, the mechanism of thyroid related ophthalmopathy, the intervention strategy and evaluation of orbital development with congenital microphthalmia and anophthalmia, blepharophimosis genotype-phenotype relationship and intervention strategies and clinical study of new materials for frontal muscle suspension. These studies represented the level and influence of Chinese oculoplastics and orbital disease in the international academic community and they were the landmark studies in our areas of expertise.

An analysis of subject areas and country participation for all health-related projects in the EU's FP5 and FP6 programmes.

BACKGROUND: Previous analyses concerning health components of European Union (EU)-funded research have shown low project participation levels of the 12 newest member states (EU-12). Additionally, there has been a lack of subject-area analysis. In the Health Research for Europe project, we screened all projects of the EU's Framework Programmes for research FP5 and FP6 (1998-2006) to identify health research projects and describe participation by country and subject area. METHODS: FP5 and FP6 project databases were acquired and screened by coders to identify health-related projects, which were then categorized according to the 47 divisions of the EU Health Portal (N = 2728 projects) plus an extra group of 'basic/biotech' projects (N = 1743). Country participation and coordination rates for projects were also analyzed. RESULTS: Approximately 20% of the 26 946 projects (value €29.2bn) were health-related (N = 4756. Value €6.04bn). Within the health categories, the largest expenditures were cancer (11.9%), 'other' (i.e. not mental health or cardiovascular) non-communicable diseases (9.5%) and food safety (9.4%). One hundred thirty-two countries participated in these projects. Of the 27 EU countries (and five partner countries), north-western and Nordic states acquired more projects per capita. The UK led coordination with > 20% of projects. EU-12 countries were generally under-represented for participation and coordination. CONCLUSIONS: Combining our findings with the associated literature, we comment on drivers determining distribution of participation and funds across countries and subject areas. Additionally, we discuss changes needed in the core EU projects database to provide greater transparency, data exploitation and return on investment in health research.

Citation analysis may severely underestimate the impact of clinical research as compared to basic research.

BACKGROUND: Citation analysis has become an important tool for research performance assessment in the medical sciences. However, different areas of medical research may have considerably different citation practices, even within the same medical field. Because of this, it is unclear to what extent citation-based bibliometric indicators allow for valid comparisons between research units active in different areas of medical research. METHODOLOGY: A visualization methodology is introduced that reveals differences in citation practices between medical research areas. The methodology extracts terms from the titles and abstracts of a large collection of publications and uses these terms to visualize the structure of a medical field and to indicate how research areas within this field differ from each other in their average citation impact. RESULTS: Visualizations are provided for 32 medical fields, defined based on journal subject categories in the Web of Science database. The analysis focuses on three fields: Cardiac & cardiovascular systems, Clinical neurology, and Surgery. In each of these fields, there turn out to be large differences in citation practices between research areas. Low-impact research areas tend to focus on clinical intervention research, while high-impact research areas are often more oriented on basic and diagnostic research. CONCLUSIONS: Popular bibliometric indicators, such as the h-index and the impact factor, do not correct for differences in citation practices between medical fields. These indicators therefore cannot be used to make accurate between-field comparisons. More sophisticated bibliometric indicators do correct for field differences but still fail to take into account within-field heterogeneity in citation practices. As a consequence, the citation impact of clinical intervention research may be substantially underestimated in comparison with basic and diagnostic research.

Full length articles published in BJOMS during 2010-11--an analysis by sub-specialty and study type.

Full length articles such as prospective and retrospective studies, case series, laboratory-based research and reviews form the majority of papers published in the British Journal of Oral and Maxillofacial Surgery (BJOMS). We were interested to evaluate the breakdown of these types of articles both by sub-specialty and the type of study as well as the proportion that are written by UK colleagues compared to overseas authors over a 2 year period (2010-11). A total of 191 full length articles across all sub-specialties of our discipline were published, with 107 papers (56%) coming from UK authors. There were proportionately more oncology papers arising from the UK than overseas (60 and 30% of total respectively) while the opposite was found for cleft/deformity studies (10% and 22%). There was only one laboratory-based study published from the UK compared with 27 papers from overseas. The number of quality papers being submitted to the Journal continues to increase, and the type of article being published between UK and overseas probably reflects different practices and case-loads amongst colleagues. The relatively few UK laboratory based studies published in BJOMS compared to overseas authors are most likely due to authors seeking the most prestigious journals possible for their work.

Level of evidence gap in orthopedic research.

Level of evidence is the most widely used metric for the quality of a publication, but instances exist in which a Level I study is neither feasible nor desirable. The goal of this study was to evaluate the level of evidence gap in current orthopedic research, which the authors defined as the disparity between the level of evidence that would be required to optimally answer the primary research question and the level of evidence that was actually used. Five orthopedic surgeons (K.D.B., J.B., J.A., S.D.M., W.N.S.) evaluated blinded articles from the first 6 months of 2010 in the Journal of Bone and Joint Surgery (American Volume) (JBJS-Am), classifying the study type and design and extracting a primary research question from each article. Each evaluator then defined the study type and method, along with the level of evidence that would ideally be used to address the primary research question. The level of evidence gap was then calculated by subtracting the actual level of evidence of the manuscript from the level of evidence of the idealized study. Of the 64 JBJS-Am manuscripts eligible for analysis, the average level of evidence was between Level II and III (mean, 2.73). The average level of evidence gap was 1.06 compared with the JBJS-Am-designated level of evidence and 1.28 compared with the evaluators' assessment. Because not all questions require Level I studies, level of evidence alone may not be the best metric for the quality of orthopedic surgery literature. Instead, the authors' concept of a level of evidence gap may be a better tool for assessing the state of orthopedic research publications.

Women in HIV conference research: trends and content analysis of abstracts presented at 17 HIV/AIDS conferences from 2003 to 2010.

OBJECTIVE: HIV/AIDS conferences provide an opportunity to review current research from around the world. Conferences are a good gauge of the amount of research conducted on HIV/AIDS and women because papers are disseminated widely and publicly, and can represent published or unpublished material. The objective of this study was to conduct content analysis and data coding to quantify trends in women-specific research in HIV/AIDS abstracts at the International AIDS Conferences (AIDS), the Canadian Association for HIV Research (CAHR) Conferences, and the Conferences on Retroviruses and Opportunistic Infections (CROI) over a 7-year time period. METHODS: Abstracts titles and text containing female keywords were retrieved from the AIDS, CAHR, and CROI conferences between 2003 and 2009 and coded according to research category using content analysis. RESULTS: Over 34,000 abstracts were searched. A total of 5,221 abstracts related to women (13.7%) were found over 7 years. Women-specific abstracts represented 16.2% (n = 4,245/26,175) at AIDS, 13.7% (n = 257/1,876) at CAHR, and 11.1% (n = 719/6,370) at CROI. The AIDS and CAHR conferences demonstrated a slightly increasing trend in women-specific abstracts over 7 years. In categorical coding, the most prevalent research category was reproductive health, and the most infrequent was policy and program evaluation. CONCLUSION: The AIDS conferences showed an increase in women-specific abstracts over time, probably owing to a gender policy implemented in 2008 and a women's research award. The CAHR conference instituted a gender policy in 2011, and the CROI conference should follow suit. Conference abstracts should include breakdown and analysis by gender.

Investigación clínica: aproximación a sus tipos y sus formas de financiamiento / Clinical research: an approximation to its types and sponsoring

La investigación se realiza con el propósito de generar nuevos conocimientos o la aplicación de estos. La investigación clínica es una forma especial de investigación médica. La industria farmacéutica es una de las más importantes formas de financiamiento de la investigación clínica. Los médicos que participan solo en la recolección de datos, en estudios de investigación clínica, son considerados como investigadores y tienen la misión de elegir adecuadas formas de financiamiento que mantengan los estándares éticos y de calidad en investigación.

Investigation is conducted with the purpose of the generation of new data or its application. Clinical investigation is a special form of medical investigation. Pharmaceutical industry is one of the most important forms of sponsorship of clinical investigation. Doctors who participate only in data collection are considered as investigators and have the mission to select adequate sponsors, in order to maintain the ethical and quality issues that investigation requires.

Description, justification and clarification: a framework for classifying the purposes of research in medical education.

CONTEXT: Authors have questioned the degree to which medical education research informs practice and advances the science of medical education. OBJECTIVE: This study aims to propose a framework for classifying the purposes of education research and to quantify the frequencies of purposes among medical education experiments. METHODS: We looked at articles published in 2003 and 2004 in Academic Medicine, Advances in Health Sciences Education, American Journal of Surgery, Journal of General Internal Medicine, Medical Education and Teaching and Learning in Medicine (1459 articles). From the 185 articles describing education experiments, a random sample of 110 was selected. The purpose of each study was classified as description ('What was done?'), justification ('Did it work?') or clarification ('Why or how did it work?'). Educational topics were identified inductively and each study was classified accordingly. RESULTS: Of the 105 articles suitable for review, 75 (72%) were justification studies, 17 (16%) were description studies, and 13 (12%) were clarification studies. Experimental studies of assessment methods (5/6, 83%) and interventions aimed at knowledge and attitudes (5/28, 18%) were more likely to be clarification studies than were studies addressing other educational topics (< 8%). CONCLUSIONS: Clarification studies are uncommon in experimental studies in medical education. Studies with this purpose (i.e. studies asking: 'How and why does it work?') are needed to deepen our understanding and advance the art and science of medical education. We hope that this framework stimulates education scholars to reflect on the purpose of their inquiry and the research questions they ask, and to strive to ask more clarification questions.

The BRIDG project: a technical report.

OBJECTIVES: The Biomedical Research Integrated Domain Group (BRIDG) project is a collaborative initiative between the National Cancer Institute (NCI), the Clinical Data Interchange Standards Consortium (CDISC), the Regulated Clinical Research Information Management Technical Committee (RCRIM TC) of Health Level 7 (HL7), and the Food and Drug Administration (FDA) to develop a model of the shared understanding of the semantics of clinical research. DESIGN: The BRIDG project is based on open-source collaborative principles and an implementation-independent, use-case driven approach to model development. In the BRIDG model, declarative and procedural knowledge are represented using the Unified Modeling Language (UML) class, activity and state diagrams. MEASUREMENTS: The BRIDG model currently contains harmonized semantics from four project use cases: the caXchange project and the patient study calendar project from caBIG; the standard data tabular model (SDTM) from CDISC; and the regulated products submission model (RPS) from HL7. Scalable harmonization processes have been developed to expand the model with content from additional use cases. RESULTS: The first official release of the BRIDG model was published in June 2007. Use of the BRIDG model by the NCI has supported the rapid development of semantic interoperability across applications within the caBIG program. CONCLUSIONS: The BRIDG project has brought together different standards communities to clarify the semantics of clinical research across pharmaceutical, regulatory, and research organizations. Currently, the NCI uses the BRIDG model to support interoperable application development in the caBIG, and CDISC and HL7 are using the BRIDG model to support standards development.

Issues in integrating epidemiology and research information in oncology: experience with ICD-O3 and the NCI Thesaurus.

The integration of the International Classification of Diseases for Oncology (ICD-O) and the NCI Thesaurus (NCIT) is expected to facilitate the integration of epidemiology data (cancer registries) with basic and clinical research data. We evaluated the degree to which ICD-O and NCIT provide consistent representations of neoplasms. 1,550 concepts (515 for topography and 1,035 for morphology) are shared by ICD-O and NCIT. Only 366 relations (about 1%) between these topography and morphology concepts are shared between ICD-O and NCIT. Two relationships--Disease Has Primary Anatomic Site and Disease Has Associated Anatomic Site--representing the anatomical site of a disease account for about 78% of the 1,376 relations between shared topography and morphology concepts in ICD-O and NCIT. In addition to these two roles, nine other NCIT relationships are found between topography and morphology concepts. Several issues are discussed, including incomplete representations in NCIT, mapping issues, systematic polysemy, and the use of post vs. pre-coordinated terms. The methods proposed provide a framework for analyzing inconsistencies.

Phase I research and the meaning of direct benefit.

In this article, I examine whether Phase I pediatric oncology trials offer "the prospect of direct benefit," a concept found in Subpart D of the Code of Federal Regulations (CFR), the guidelines that provide additional protections to pediatric research subjects. In research that offers the prospect of direct benefit, children can be exposed to greater risk than in other research and their dissent can be overridden. I argue that Phase I trials do not offer the prospect of direct benefit and classifying them as if they do fails to acknowledge the moral relevance of the researchers' intent. In Subpart D, research that does not provide the prospect of direct benefit can be approved locally if it does not expose the children to more than a minor increase over minimal risk. If the risks are greater, the research must be approved nationally. To avoid the need for national review for Phase I oncology trials, I propose a new research category that incorporates the concept of "secondary direct benefit." In this category, the child's dissent would be dispositive. This new category would improve the protections provided to children by incorporating intentions into Subpart D, the absence of which is a serious flaw in our current regulatory schema.