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      Factors influencing the participation of gastroenterologists and hepatologists in clinical research

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          Abstract

          Background

          Although clinical research is integral to the advancement of medical knowledge, physicians face a variety of obstacles to their participation as investigators in clinical trials. We examined factors that influence the participation of gastroenterologists and hepatologists in clinical research.

          Methods

          We surveyed 1050 members of the American Association for the Study of Liver Diseases regarding their participation in clinical research. We compared the survey responses by specialty and level of clinical trial experience.

          Results

          A majority of the respondents (71.6%) reported involvement in research activities. Factors most influential in clinical trial participation included funding and compensation (88.3%) and intellectual pursuit (87.8%). Barriers to participation were similar between gastroenterologists (n = 160) and hepatologists (n = 189) and between highly experienced (n = 62) and less experienced (n = 159) clinical researchers. These barriers included uncompensated research costs and lack of specialized support. Industry marketing was a greater influence among respondents with less trial experience, compared to those with extensive experience (15.7% vs 1.6%; P < .01). Hepatologists and respondents with extensive clinical trial experience tended to be more interested in phase 1 and 2 studies, whereas gastroenterologists and less experienced investigators were more interested in phase 4 studies.

          Conclusion

          This study suggests that the greatest barrier to participation in clinical research is lack of adequate resources. Respondents also favored industry-sponsored research with less complex trial protocols and studies of relatively short duration.

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          Most cited references26

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          Translational and clinical science--time for a new vision.

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            Simply no time? Barriers to GPs' participation in primary health care research.

            Non-participation of general practitioners (GPs) is a serious source of bias for practice-based studies. Objective. To elucidate doctors' motives for non-participation in, and subjective barriers to, general practice research. German GPs that had opted out of a quality assessment project involving electronic patient records (EPRs) were mailed a questionnaire regarding their attitudes towards general practice research and their specific objections to the current project. A sub-sample of doctors was interviewed. Their statements were coded and classified with regard to the reasons given for non-participation and possible motivating factors. The survey response rate was 37% (96/263); 21 GPs completed an additional qualitative interview. Nearly all respondents (88/96) considered general practice research to be important, but 58% had not previously participated in research projects and 56% would not do so in the future. Nearly half (47/96) were opposed to having data extracted from their EPRs. The qualitative analysis revealed deep concerns related to the collection of EPRs (e.g. potential misuse of data, being subject to control or resulting computer problems). Some GPs expressed concerns about recruiting their own patients for the study. Some doctors complained of not being sufficiently recognized as a partner or not having a voice in the research process. Doctors' negative attitudes, concerns and ambivalent feelings should be addressed in recruitment strategies, especially when the analysis of EPRs or direct patient contact is required. Some doctors do not participate in research out of principle and will be very difficult to convince.
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              Financial anatomy of biomedical research.

              Public and private financial support of biomedical research have increased over the past decade. Few comprehensive analyses of the sources and uses of funds are available. This results in inadequate information on which to base investment decisions because not all sources allow equal latitude to explore hypotheses having scientific or clinical importance and creates a barrier to judging the value of research to society. To quantify funding trends from 1994 to 2004 of basic, translational, and clinical biomedical research by principal sponsors based in the United States. Publicly available data were compiled for the federal, state, and local governments; foundations; charities; universities; and industry. Proprietary (by subscription but openly available) databases were used to supplement public sources. Total actual research spending, growth rates, and type of research with inflation adjustment. Biomedical research funding increased from 37.1 billion dollars in 1994 to 94.3 billion dollars in 2003 and doubled when adjusted for inflation. Principal research sponsors in 2003 were industry (57%) and the National Institutes of Health (28%). Relative proportions from all public and private sources did not change. Industry sponsorship of clinical trials increased from 4.0 dollars to 14.2 billion dollars (in real terms) while federal proportions devoted to basic and applied research were unchanged. The United States spent an estimated 5.6% of its total health expenditures on biomedical research, more than any other country, but less than 0.1% for health services research. From an economic perspective, biotechnology and medical device companies were most productive, as measured by new diagnostic and therapeutic devices per dollar of research and development cost. Productivity declined for new pharmaceuticals. Enhancing research productivity and evaluation of benefit are pressing challenges, requiring (1) more effective translation of basic scientific knowledge to clinical application; (2) critical appraisal of rapidly moving scientific areas to guide investment where clinical need is greatest, not only where commercial opportunity is currently perceived; and (3) more specific information about sources and uses of research funds than is generally available to allow informed investment decisions. Responsibility falls on industry, government, and foundations to bring these changes about with a longer-term view of research value.
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                Author and article information

                Journal
                BMC Health Serv Res
                BMC Health Services Research
                BioMed Central
                1472-6963
                2008
                8 October 2008
                : 8
                : 208
                Affiliations
                [1 ]Duke Clinical Research Institute, PO Box 17969, Durham, North Carolina, USA
                [2 ]Division of Gastroenterology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA
                [3 ]Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA
                [4 ]Monash University, Melbourne, Australia
                [5 ]University of Florida, Gainesville, USA
                [6 ]University of New South Wales, Sydney, Australia
                Article
                1472-6963-8-208
                10.1186/1472-6963-8-208
                2572062
                18842135
                d8112169-b725-49d6-823d-5c8a969068e5
                Copyright © 2008 Dev et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 30 April 2008
                : 8 October 2008
                Categories
                Research Article

                Health & Social care
                Health & Social care

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