Search

Background: At the beginning of the 2000s, Norwegian research in nursing and allied health disciplines was described as weak. Since 2007, the Northern Norway Regional Health Authority has had a strategic focus on enhancing health research. Objective: The objective of this project was to evaluate whether the Northern Norway Regional Health Authority's research investment has given results. We have examined research activity, the allocation of research funding, research outputs and facilitating factors for research to be conducted by health researchers (excluding doctors and dentists) in the health trusts. Method: The survey took place in four health trusts under the Northern Norway Regional Health Authority. In the survey, we used a multi-method approach and a variety of data sources. Quantitative mapping based on research administrative data and systematic searches for published scientific output registered in journal databases were used together with data from a survey conducted among health researchers and research fellows in 2015. Results: In the period 2008-2015, there was an increase in the number of research fellows, researchers and published scientific output in the health trusts. Competence enhancement has been greatest in nursing and physiotherapy. Researchers and research fellows have contributed to multi-disciplinary research, using a broad range of methodological approaches with a preponderance of qualitative methods. On average, 29 per cent of the articles published in the period were published in level 2 journals. The Northern Norway Regional Health Authority has been the main funding source for the research. The respondents reported time pressure, lack of funding, research culture and adaptation for research as obstacles to conducting research. Conclusion: There has been a positive development in and strengthening of health research and research-based competence in the Northern Norway Regional Health Authority during the relevant period of time. The results indicate that strategic investment in health research has had a positive effect, and that a similar focus is also recommended for other health authorities. [ABSTRACT FROM AUTHOR]

Background: Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers.Methods: We performed systematic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.Results: The following barriers to randomised clinical trials were identified: inadequate knowledge of clinical research and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors, and multinational cooperation is essential.Conclusions: The present paper presents major barriers to randomised clinical trials. It also underlines the value of using a pan-European-distributed infrastructure to help investigators overcome barriers for multi-country trials in any disease area. [ABSTRACT FROM AUTHOR]

Background: Clinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle East, and Africa. Our study objectives were to evaluate the current characteristics of clinical trials and to find out the associated multiple factors which could explain clinical trial globalization and its implications for clinical trial globalization in 2011-2013.Methods: The data elements of "phase," "recruitment status," "type of sponsor," "age groups," and "design of trial" from 30 countries were extracted from the ClinicalTrials.gov website. Ten continental representative countries including the USA were selected and the design elements were compared to those of the USA. Factors associated with trial site distribution were chosen for a multilinear regression analysis.Results: The USA, Germany, France, Canada, and United Kingdom were the "top five" countries which frequently held clinical trials. The design elements from nine continental representative countries were quite different from those of the USA; phase 1 trials were more prevalent in India (OR 1.517, p < 0.001) while phase 3 trials were much more prevalent in all nine representative countries than in the USA. A larger number of "child" age group trials was performed in Poland (OR 1.852, p < 0.001), Israel (OR 1.546, p = 0.005), and South Africa (OR 1.963, p < 0.001) than in the USA. Multivariate analysis showed that health care expenditure per capita, Economic Freedom Index, Human Capital Index, and Intellectual Property Rights Index could explain the variance of regional distribution of clinical trials by 63.6%.Conclusions: The globalization of clinical trials in the emerging regions of Asia, South Africa, and Eastern Europe developed in parallel with the factors of economic drive, population for recruitment, and regulatory constraints. [ABSTRACT FROM AUTHOR]

Background: The extent to which trial-level factors differentially influence accrual to trials has not been comprehensively studied. Our objective was to evaluate the empirical relationship and predictive properties of putative risk factors for low accrual in the National Cancer Institute's (NCI's) Cooperative Group Program, now the National Clinical Trials Network (NCTN).Methods: Data from 787 phase II/III adult NCTN-sponsored trials launched between 2000 and 2011 were used to develop a logistic regression model to predict low accrual, defined as trials that closed with or were accruing at less than 50% of target; 46 trials opened between 2012 and 2013 were used for prospective validation. Candidate predictors were identified from a literature review and expert interviews; final predictors were selected using stepwise regression. Model performance was evaluated by calibration and discrimination via the area under the curve (AUC). All statistical tests were two-sided.Results: Eighteen percent (n = 145) of NCTN-sponsored trials closed with low accrual or were accruing at less than 50% of target three years or more after initiation. A multivariable model of twelve trial-level risk factors had good calibration and discrimination for predicting trials with low accrual (AUC in trials launched 2000-2011 = 0.739, 95% confidence interval [CI] = 0.696 to 0.783]; 2012-2013: AUC = 0.732, 95% CI = 0.547 to 0.917). Results were robust to different definitions of low accrual and predictor selection strategies.Conclusions: We identified multiple characteristics of NCTN-sponsored trials associated with low accrual, several of which have not been previously empirically described, and developed a prediction model that can provide a useful estimate of accrual risk based on these factors. Future work should assess the role of such prediction tools in trial design and prioritization decisions. [ABSTRACT FROM AUTHOR]

We describe past NIH funding for tobacco/nicotine-related research, using data from the CRISP computerized database of NIH grants awarded in 1975, 1980, 1985, 1990, and 1995 (last year available). Two independent raters identified extramural grants whose investigators listed a nicotine/tobacco-related keyword as a primary descriptor for 1975, 1980, 1985, 1990, and 1995. From 1975 to 1985 extramural funding for nicotine/tobacco research (corrected for inflation) increased almost fourfold. From 1985 to 1995, funding increased minimally (< 20%). In 1995, NIH expended $92.1 million on research whose primary interest was nicotine or tobacco. This represented 1.1% of the overall NIH extramural budget. Over time, when contract funding increased, investigator-initiated R01 funding decreased. Nicotine/tobacco research was spread across 18 institutes. Although tobacco use accounts for 20% of all US mortality, historically only 1% of the NIH's budget has focused on nicotine or tobacco. Among nicotine/tobacco grants funded, investigator-initiated research appears to have been limited due to large contracts for clinical trials. Nicotine/tobacco research has no home institute. Funding for nicotine/tobacco research needs to be increased and better coordinated. [ABSTRACT FROM AUTHOR]