Productivity of CNPq Researchers from Different Fields in Biomedical Sciences: The Need for Objective Bibliometric Parameters-A Report from Brazil.

In Brazil, the CNPq (National Council for Scientific and Technological Development) provides grants, funds and fellowships to productive scientists to support their investigations. They are ranked and categorized into four hierarchical levels ranging from PQ 1A (the highest) to PQ 1D (the lowest). Few studies, however, report and analyse scientific productivity in different sub-fields of Biomedical Sciences (BS), e.g., Biochemistry, Pharmacology, Biophysics and Physiology. In fact, systematic comparisons of productivity among the PQ 1 categories within the above sub-fields are lacking in the literature. Here, the scientific productivity of 323 investigators receiving PQ 1 fellowships (A to D levels) in these sub-fields of BS was investigated. The Scopus database was used to compile the total number of articles, citations, h-index values and authorship positions (first-, co- or last-listed author) in the most cited papers by researchers granted CNPq fellowships. We found that researchers from Pharmacology had the best performance for all of the parameters analysed, followed by those in Biochemistry. There was great variability in scientific productivity within the PQ 1A level in all of the sub-fields of BS, but not within the other levels (1B, 1C and 1D). Analysis of the most cited papers of PQ 1(A-D) researchers in Pharmacology revealed that the citations of researchers in the 1C and 1D levels were associated with publications with their senior supervisors, whereas those in the 1B level were less connected with their supervisors in comparison to those in 1A. Taken together, these findings suggest that the scientific performance of PQ 1A researchers in BS is not homogenous. In our opinion, parameters such as the most cited papers without the involvement of Ph.D. and/or post-doctoral supervisors should be used to make decisions regarding any given researcher's fellowship award level.

¿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)

Assessment of research quality in major infertility journals.

OBJECTIVE: To evaluate the level of evidence published in infertility journals with the highest impact factors. DESIGN: Systematic review. We searched in PubMed identifying potential systematic reviews with meta-analysis (SRs) and randomized controlled trials (RCTs) between 2006 and 2010 in the five fertility journals with highest impact factor. SETTING: Academic institution. PATIENT(S): None. INTERVENTION(S): None. MAIN OUTCOMES MEASURE(S): Number and proportion of potential SRs and RCTs published in 2006-2011, and quality assessment of real RCTs published in 2010. RESULT(S): Among evaluated articles, 1.5% and 6.8% were SRs and RCTs. Fertility and Sterility has been the journal with more potential SRs and RCTs, and Human Reproduction Update was the only one with an increasing trend in the number of potential SRs (from 5.3% in 2006 to 24.4% in 2011). Among confirmed RCTs, for each quality assessment item, between 50% and 85% were classified as having low risk of bias, and the most common high risk of bias was related to allocation concealment. Only 23% had a trial registration, which were associated with higher quality assessment classifications. Only 10% of RCTs reported pharmaceutical industry funding. CONCLUSION(S): This is the first study assessing the methodologic quality of publications in the top five fertility journals. More than 90% of all the publications were neither SRs nor RCTs. It is remarkable that the risk of bias was generally low. Enhancing trial registration and funding source statements represent opportunities to improve the quality of reporting. We hope this information is useful to researchers, editorial boards, and clinicians moving forward with research in our field.

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.

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.