The positive predictive values of the 4 monitored ADEs were approximately 44.4% to 95.8%. CONCLUSIONS An automatic ADE screening system was established for hospitalized patients in Chinese medical institutions. Compared with previous studies, combined drug-event alerts and a system-assisted assessment interface performed better than alerts based only on laboratory values. Furthermore, this platform's assisted-layered evaluation and risk factor analysis functions could save considerable time for professionals and improve early prevention of potentially serious ADEs. To date, this system has been applied in 10 large-scale medical institutions.BACKGROUND Patients and health care professionals receive information about pharmaceutical companies through various sources, including but not limited to print media, social media, and electronic media. The objective of this research was to benchmark the sentiment of electronic newspaper media coverage between 2014 and 2016 and investigate the potential relationship to the public perception of the select pharmaceutical companies. METHODS Reputation Institute's RepTrak System report was used for selection of 5 highly rated pharmaceutical companies (A-E). Electronic newspapers were selected based on US circulation within the selected time period. Lexalytics sentiment analysis software was used for analysis of relevant articles appearing in the selected newspapers. RESULTS A total of 797 articles were analyzed; 63% were assessed as neutral, 24% as negative, and 14% as positive. The overall median sentiment scores (scale ranging from -2 through [Formula see text]2) for companies A through E across all newspapers were determined to be [Formula see text]0.026, [Formula see text]0.03, [Formula see text]0.028, [Formula see text]0.034, and [Formula see text]0.033, respectively. The most frequent topics were merger/acquisition/ re-structuring, finances/stocks/profits, and other, which included topics such as transparency of pharmaceutical industry data, lack of drug efficacy, and innovation. CONCLUSION Overall, pharmaceutical companies were represented similarly across newspapers and most articles were assessed as neutral. However, on analysis of all nonneutral articles, all categories were assessed as negative with the exception of finances/stocks/profits.BACKGROUND Confirmatory phase III trials aim to provide decisive evidence about a medical product's safety and efficacy. Although these trials are planned and conducted based on accumulated knowledge, they are not without risk or uncertainty. A trial prematurely concluding contributes to great loss in both financial and human research resources. METHODS We categorized and evaluated trials concluded prematurely after recruitment had begun, as registered in Clinical Trials.gov between January 2013 and August 2017. RESULTS We found 9828 registered interventional phase III trials; of those, 320 were concluded prematurely. Many clinical trials were concluded prematurely for reasons related to reducing participant risk, such as interim stopping for safety, efficacy, or futility. Yet, 70% trials were halted for other reasons, such as insufficient recruitment (the most often cited reason) or unspecified business decisions. Of all prematurely concluded trials, 102 trials evaluated 72 different novel therapeutics; in 66.7% of these trials, the clinical development program was stopped entirely.  https://www.selleckchem.com/products/Decitabine.html  Most of the prematurely concluded trials (78%) had not provided results to ClinicalTrials.gov at the time of this analysis. CONCLUSIONS Evaluation of the factors that influence premature conclusion could inform solutions for improving research participation and help ensure trial completion. Registering and reporting results acknowledges the voluntary contribution and consent expectations of research participants.BACKGROUND The US Food and Drug Administration conducts on-site inspections and data audits through Bioresearch Monitoring program for assurance of the quality and integrity of data in the pre- and postapproval processes. It is important to inspect the study sites that are different compared with other sites in clinical studies and identify the problems related to those sites. Usually one cannot inspect all the sites in a clinical study because of limited resources, and statistical tools are needed to help in selecting sites for inspection. METHODS We propose two technical approaches, namely Fisher combination approach and likelihood ratio test (LRT) approach, for site selection, with each approach integrating the information obtained from a P value matrix. The proposed approaches produce site rankings, and the sites with highest rankings may be selected for inspection. RESULTS The application of the approaches is demonstrated through a hypothetical data set reflecting the pattern of the real data in a premarket approval submission for a diagnostic device. The proposed methods are shown, through extensive simulations, to control false discovery rate, while maintaining good sensitivity. CONCLUSION The proposed approaches will be useful for site selection process. However, limitations exist when only using the statistical approaches proposed here. In practice, investigators will select the site for inspection by considering the outputs from the statistical approaches along with other important factors. Future research topic is discussed to facilitate practical application of the approaches.BACKGROUND The DIA Adaptive Designs Scientific Working Group has a devoted subteam to performing surveys, literature reviews, and registry reviews every 4 years to assess the perception and use of adaptive designs (ADs) in the development of drugs and biologics. METHODS A survey was distributed to pharmaceutical companies, academic institutions, and contract research organizations to collect information about the usage of ADs of different types and perception of challenges for their use. Literature and registry reviews were conducted to assess the prevalence of ADs of different types in drug and biologics development. These results were compared to previous surveys and reviews using summary statistics. RESULTS ADs appear to be more widely considered in the last 4 years as compared to earlier 4-year periods. CONCLUSIONS The most common types of ADs remain early stopping, treatment group adaptations, and sample size re-estimation. Both stopping early for safety and changing the endpoint of the analyses were rarely mentioned in literature prior to 2012 but are now appearing more frequently.