Results and Outcome Reporting In ClinicalTrials.gov, What Makes it Happen?

At the end of the past century there were multiple concerns regarding lack of transparency in the conduct of clinical trials as well as some ethical and scientific issues affecting the trials' design and reporting. In 2000 ClinicalTrials.gov data repository was developed and deployed to serve public and scientific communities with valid data on clinical trials. Later in order to increase deposited data completeness and transparency of medical research a set of restrains had been imposed making the results deposition compulsory for multiple cases.We investigated efficiency of the results deposition and outcome reporting as well as what factors make positive impact on providing information of interest and what makes it more difficult, whether efficiency depends on what kind of institution was a trial sponsor. Data from the ClinicalTrials.gov repository has been classified based on what kind of institution a trial sponsor was. The odds ratio was calculated for results and outcome reporting by different sponsors' class.As of 01/01/2012 118,602 clinical trials data deposits were made to the depository. They came from 9068 different sources. 35344 (29.8%) of them are assigned as FDA regulated and 25151 (21.2%) as Section 801 controlled substances. Despite multiple regulatory requirements, only about 35% of trials had clinical study results deposited, the maximum 55.56% of trials with the results, was observed for trials completed in 2008.The most positive impact on depositing results, the imposed restrains made for hospitals and clinics. Health care companies showed much higher efficiency than other investigated classes both in higher fraction of trials with results and in providing at least one outcome for their trials. They also more often than others deposit results when it is not strictly required, particularly, in the case of non-interventional studies

Biomass equations for forest regrowth in the eastern Amazon using randomized branch sampling.

Florestas secundárias ocupam uma área extensa e crescente na bacia Amazônica, porém determinações acuradas do impacto dessas florestas nos ciclos de carbono e nutrientes têm sido dificultadas pelo número reduzido de equações alométricas. Neste estudo, nós desenvolvemos equações em nível de comunidade e espécies individuais para estimar a biomassa total da parte aérea de uma floresta secundária com 15 anos de idade na Amazônia oriental. O trabalho de campo utilizou amostragem aleatória de ramos, que é uma técnica rápida, porém pouco utilizada em florestas tropicais. Baseada no erro padrão da série de segmentos individuais (14%), a consistência da série de segmentos totais amostrados foi considerada elevada, sugerindo que o método pode ser eficiente em comparação com procedimentos tradicionais. Os melhores ajustes foram obtidos com a equação tradicional Y=a×DBHb, onde Y é a biomassa, DBH é o diâmetro à altura do peito, e a e b são parâmetros para cada espécie arbórea. Ajustes razoáveis também foram alcançados com equações da forma Y=a(BA×H), onde Y é a biomassa, BA é a área basal, H é a altura e a é um parâmetro específico para cada espécie arbórea. Comparações com equações disponíveis na literatura indicaram uma faixa de erro provável de -33% a +29% usando-se relações desenvolvidas para outros sítios. Nós também apresentamos equações para os seguintes componentes da biomassa da parte aérea: tronco, ramos e folhas

Primate Extinction Risk and Historical Patterns of Speciation and Extinction in Relation to Body Mass

Body mass is thought to influence diversification rates, but previous studies have produced ambiguous results. We investigated patterns of diversification across 100 trees obtained from a new Bayesian inference of primate phylogeny that sampled trees in proportion to their posterior probabilities. First, we used simulations to assess the validity of previous studies that used linear models to investigate the links between IUCN Red List status and body mass. These analyses support the use of linear models for ordinal ranked data on threat status, and phylogenetic generalized linear models revealed a significant positive correlation between current extinction risk and body mass across our tree block. We then investigated historical patterns of speciation and extinction rates using a recently developed maximum-likelihood method. Specifically, we predicted that body mass correlates positively with extinction rate because larger bodied organisms reproduce more slowly, and body mass correlates negatively with speciation rate because smaller bodied organisms are better able to partition niche space. We failed to find evidence that extinction rates covary with body mass across primate phylogeny. Similarly, the speciation rate was generally unrelated to body mass, except in some tests that indicated an increase in the speciation rate with increasing body mass. Importantly, we discovered that our data violated a key assumption of sample randomness with respect to body mass. After correcting for this bias, we found no association between diversification rates and mass.Human Evolutionary Biolog

Science-Technology-Industry Network The Competitiveness of Swiss Biotechnology: A Case Study of Innovation

This study proposes to analyse in an exploratory way the state of innovation and production systems in Swiss biotechnology and especially its innovative capacity and related factors. As biotechnology as such cannot be considered as an industrial sector but rather as a set of technologies developed in the field of life sciences, the direct link with science makes innovative capacity a major determinant of competitiveness. While large multinationals, such as biopharmaceuticals, may not need local technology suppliers, the presence of a local industry of research-based firms and technology suppliers is critical, because the industry is, by itself, a major source of growth and social progress. By observing how research and development (R&D) activities are organised in the field of biotechnology, we try to identify the relations existing between universities and the biotechnology industry, but also the relations between biotechnology firms among themselves.

The Database for Aggregate Analysis of ClinicalTrials.gov (AACT) and Subsequent Regrouping by Clinical Specialty

BACKGROUND: The ClinicalTrials.gov registry provides information regarding characteristics of past, current, and planned clinical studies to patients, clinicians, and researchers; in addition, registry data are available for bulk download. However, issues related to data structure, nomenclature, and changes in data collection over time present challenges to the aggregate analysis and interpretation of these data in general and to the analysis of trials according to clinical specialty in particular. Improving usability of these data could enhance the utility of ClinicalTrials.gov as a research resource. METHODS/PRINCIPAL RESULTS: The purpose of our project was twofold. First, we sought to extend the usability of ClinicalTrials.gov for research purposes by developing a database for aggregate analysis of ClinicalTrials.gov (AACT) that contains data from the 96,346 clinical trials registered as of September 27, 2010. Second, we developed and validated a methodology for annotating studies by clinical specialty, using a custom taxonomy employing Medical Subject Heading (MeSH) terms applied by an NLM algorithm, as well as MeSH terms and other disease condition terms provided by study sponsors. Clinical specialists reviewed and annotated MeSH and non-MeSH disease condition terms, and an algorithm was created to classify studies into clinical specialties based on both MeSH and non-MeSH annotations. False positives and false negatives were evaluated by comparing algorithmic classification with manual classification for three specialties. CONCLUSIONS/SIGNIFICANCE: The resulting AACT database features study design attributes parsed into discrete fields, integrated metadata, and an integrated MeSH thesaurus, and is available for download as Oracle extracts (.dmp file and text format). This publicly-accessible dataset will facilitate analysis of studies and permit detailed characterization and analysis of the U.S. clinical trials enterprise as a whole. In addition, the methodology we present for creating specialty datasets may facilitate other efforts to analyze studies by specialty groups

Development of forest structure and leaf area in secondary forests regenerating on abandoned pastures in Central Amazonia

The area of secondary forest (SF) regenerating from pastures is increasing in the Amazon basin; however, the return of forest and canopy structure following abandonment is not well understood. This study examined the development of leaf area index (LAI), canopy cover, aboveground biomass, stem density, diameter at breast height (DBH), and basal area ( BA) by growth form and diameter class for 10 SFs regenerating from abandoned pastures. Biomass accrual was tree dominated, constituting >= 94% of the total measured biomass in all forests abandoned >= 4 to 6 yr. Vine biomass increased with forest age, but its relative contribution to total biomass decreased with time. The forests were dominated by the tree Vismia spp. (> 50%). Tree stem density peaked after 6 to 8 yr ( 10 320 stems per hectare) before declining by 42% in the 12- to 14-yr-old SFs. Small-diameter tree stems in the 1-5-cm size class composed > 58% of the total stems for all forests. After 12 to 14 yr, there was no significant leaf area below 150-cm height. Leaf area return (LAI = 3.2 after 12 to 14 yr) relative to biomass was slower than literature-reported recovery following slash-and-burn, where LAI can reach primary forest levels ( LAI = 4 - 6) in 5 yr. After 12 to 14 yr, the colonizing vegetation returned some components of forest structure to values reported for primary forest. Basal area and LAI were 50% - 60%, canopy cover and stem density were nearly 100%, and the rapid tree-dominated biomass accrual was 25% - 50% of values reported for primary forest. Biomass accumulation may reach an asymptote earlier than expected because of even-aged, monospecific, untiered stand structure. The very slow leaf area accumulation relative to biomass and to reported values for recovery following slash-and-burn indicates a different canopy development pathway that warrants further investigation of causes ( e. g., nutrient limitations, competition) and effects on processes such as evapotranspiration and soil water uptake, which would influence long-term recovery rates and have regional implications

Correlation but no causation between leaf nitrogen and maximum assimilation: the role of drought and reproduction in gas exchange in an understory tropical plant Miconia ciliata (Melastomataceae).

Alternative hypotheses were tested to explain a previously reported anomaly in the response of leaf photosynthetic capacity at light saturation (A..) in Miconia ciliata to dry-season irrigation. The anomaly is characterized by an abrupt increase in leaf A._ for nonirrigated plants at the onset of the rainy season to values that significantly exceeded corresponding measurements for plants that were irrigated during the previous dry season. Hypothesis I posits that a pulse in leaf nitrogen increases CO2 assimilation in nonirrigated plants at the onset of the wet season and is dampened for irrigated plants; this hypothesis was rejected because, although a wet-season nitrogen pulse did occur, it was identical for both irrigated and nonirrigated plants and was preceded by the increase in assimilation by nonirrigated plants. Hypothesis 2 posits that a reproduction-related, compensatory photosynthetic response occurs in nonirrigated plants following the onset of the wet season and is dampened in irrigated plants; consistent with hypothesis 2, high maximum assimilation rates for control plants in the wet season were significantly correlated with fruiting and flowering, whereas irrigation caused flowering and fruiting in the dry season, spreading M. ciliata reproductive activity in irrigated plants across the entire year

Long-term manipulation of soil moisture availability alters ecosystem processes in eastern Amazonian forest regrowth, Brazil.

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