A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

<p>Abstract</p> <p>Background</p> <p>Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to evaluate the frequency and quality of the reporting on DMC composition and roles, interim analysis and early termination in pediatric trials.</p> <p>Methods</p> <p>We conducted a systematic review of randomized controlled clinical trials published from 2005 to 2007 in a sample of four general and four pediatric journals. We used full-text databases to identify trials which reported on DMCs, interim analysis or early termination, and included children or adolescents. Information was extracted on general trial characteristics, risk of bias, and a set of parameters regarding DMC composition and roles, interim analysis and early termination.</p> <p>Results</p> <p>110 of the 648 pediatric trials in this sample (17%) reported on DMC or interim analysis or early stopping, and were included; 68 from general and 42 from pediatric journals. The presence of DMCs was reported in 89 of the 110 included trials (81%); 62 papers, including 46 of the 89 that reported on DMCs (52%), also presented information about interim analysis. No paper adequately reported all DMC parameters, and nine (15%) reported all interim analysis details. Of 32 trials which terminated early, 22 (69%) did not report predefined stopping guidelines and 15 (47%) did not provide information on statistical monitoring methods.</p> <p>Conclusions</p> <p>Reporting on DMC composition and roles, on interim analysis results and on early termination of pediatric trials is incomplete and heterogeneous. We propose a minimal set of reporting parameters that will allow the reader to assess the validity of trial results.</p

(Blue) Growth accounting in small-scale European Union fleets

Fisheries account for one-third of the total jobs in the global ocean economies. Small scale fleets (SSF) fisheries are the main segment from the number of jobs point of view, and in the EU, SSF account for over 40% of employment in the fisheries sector. Given this marine employment source, it is important to analyse SSF's productivity growth. This was done using Total Factor Productivity (TFP), which is dened as the portion of output not explained by the traditionally measured inputs of labour, energy and capital used in production. TFP calculation is relevant to understand the technology evolution in fisheries and as a reference for management assessment. TFP was calculated for SSF in two EU main sea areas, the Mediterranean (FAO area 37) and the North-East Atlantic (FAO area 27). Constant elasticity production functions were used to analyse the intensity of the use of production factors and how these are substituted or complemented when producing. Additionally, TFP was corrected by stock evolution indexes to evaluate the EU conservation policy. Results showed how the TFP presented signs of stagnation when stocks status were considered. This implies a low technological evolution and that the use of production factors is to be reduced in the following years. It was concluded that in the North-East Atlantic the EU conservation policy is obtaining the objective of restoring fish stocks and contributing to maintaining the productivity. In the Mediterranean, the stocks are not being restored, therefore not contributing to growth as a production factor. Finally, it is concluded that in neither areas the conservation policy is enough to provide positive productivity trends.JRC.D.2-Water and Marine Resource

Asian-Pacific consensus statement on the management of chronic hepatitis B: A 2012 update

Large volume of new data on the natural history and treatment of chronic hepatitis B virus (HBV) infection have become available since 2008. These include further studies in asymptomatic subjects with chronic HBV infection and community-based cohorts, the role of HBV genotype/naturally occurring HBV mutations, the application of non-invasive assessment of hepatic fibrosis and quantitation of HBV surface antigen and new drug or new strategies towards more effective therapy. To update HBV management guidelines, relevant new data were reviewed and assessed by experts from the region, and the significance of the reported findings was discussed and debated. The earlier "Asian-Pacific consensus statement on the management of chronic hepatitis B" was revised accordingly. The key terms used in the statement were also defined. The new guidelines include general management, indications for fibrosis assessment, time to start or stop drug therapy, choice of drug to initiate therapy, when and how to monitor the patients during and after stopping drug therapy. Recommendations on the therapy of patients in special circumstances, including women in childbearing age, patients with antiviral drug resistance, concurrent viral infection, hepatic decompensation, patients receiving immune suppression or chemotherapy and patients in the setting of liver transplantation and hepatocellular carcinoma, are also included