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      Patient enrollment and logistical problems top the list of difficulties in clinical research: a cross-sectional survey

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          Abstract

          Background

          Many medical research projects encounter difficulties. The objective of this study was to assess the self-reported frequency of difficulties encountered by medical researchers while conducting research and to identify factors associated with their occurrence.

          Methods

          The authors conducted a cross-sectional survey in 2010 among principal investigators of 996 study protocols approved by the Research Ethics Committee in Geneva, Switzerland, between 2001 and 2005. The authors asked principal investigators to rate the level of difficulty (1: none, to 5: very great) encountered across the research process.

          Results

          588 questionnaires were sent back (participation rate 59.0 %). 391 (66.5 %) studies were completed at the time of the survey. Investigators reported that the most frequent difficulties were related to patient enrollment (44.3 %), data collection (26.7 %), data analysis and interpretation (21.5 %), collaboration with caregivers (21.0 %), study design (20.4 %), publication in peer-reviewed journal (20.2 %), hiring of competent study personnel (20.2 %), and getting funding (19.2 %). On average, investigators reported 2.8 difficulties per project (SD 2.8, range 0 to 12). In multivariable analysis, the number of difficulties was higher for studies initiated by public sponsors (vs. private), single center studies (vs. multicenter), and studies about treatment, diagnosis or prognosis (i.e., clinical vs. other studies).

          Conclusions

          Medical researchers reported substantial logistical difficulties in conducting clinical research.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s12874-016-0151-1) contains supplementary material, which is available to authorized users.

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          Most cited references34

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          Barriers to participation in randomised controlled trials: a systematic review.

          A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers.
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            Prevalence, characteristics, and publication of discontinued randomized trials.

            The discontinuation of randomized clinical trials (RCTs) raises ethical concerns and often wastes scarce research resources. The epidemiology of discontinued RCTs, however, remains unclear. To determine the prevalence, characteristics, and publication history of discontinued RCTs and to investigate factors associated with RCT discontinuation due to poor recruitment and with nonpublication. Retrospective cohort of RCTs based on archived protocols approved by 6 research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We recorded trial characteristics and planned recruitment from included protocols. Last follow-up of RCTs was April 27, 2013. Completion status, reported reasons for discontinuation, and publication status of RCTs as determined by correspondence with the research ethics committees, literature searches, and investigator surveys. After a median follow-up of 11.6 years (range, 8.8-12.6 years), 253 of 1017 included RCTs were discontinued (24.9% [95% CI, 22.3%-27.6%]). Only 96 of 253 discontinuations (37.9% [95% CI, 32.0%-44.3%]) were reported to ethics committees. The most frequent reason for discontinuation was poor recruitment (101/1017; 9.9% [95% CI, 8.2%-12.0%]). In multivariable analysis, industry sponsorship vs investigator sponsorship (8.4% vs 26.5%; odds ratio [OR], 0.25 [95% CI, 0.15-0.43]; P < .001) and a larger planned sample size in increments of 100 (-0.7%; OR, 0.96 [95% CI, 0.92-1.00]; P = .04) were associated with lower rates of discontinuation due to poor recruitment. Discontinued trials were more likely to remain unpublished than completed trials (55.1% vs 33.6%; OR, 3.19 [95% CI, 2.29-4.43]; P < .001). In this sample of trials based on RCT protocols from 6 research ethics committees, discontinuation was common, with poor recruitment being the most frequently reported reason. Greater efforts are needed to ensure the reporting of trial discontinuation to research ethics committees and the publication of results of discontinued trials.
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              The physician-scientist career pipeline in 2005: build it, and they will come.

              Physician-scientists play a unique and critical role in medical research. Nonetheless, a number of trends followed during the 1980s and 1990s revealed that this career pathway was in serious jeopardy. Physician-scientists were declining in number and were getting older. A variety of factors were thought to contribute to this problem, including increasing indebtedness of medical school graduates caused by rapidly rising medical school tuition costs. To evaluate the impact of recently initiated programs from the National Institutes of Health (NIH) and several not-for-profit institutions designed to revitalize the physician-scientist career pipeline. We assessed recent trends in the physician-scientist career pipeline using data obtained from the NIH, the American Medical Association, the Association of American Medical Colleges, and other sources. Total numbers of physicians performing research, grant application numbers and success rates for MDs, MD-PhDs, and PhDs at various stages in their careers, interest in research among medical students, medical school tuitions and postgraduate salaries, numbers and composition of applicants for NIH loan repayment programs, and gender distribution of young physician-scientists. The number of physician-scientists in the United States has been in a steady state for the past decade, but funded physician-scientists are significantly older than they were 2 decades ago. However, the study of early career markers over the past 7 to 10 years has demonstrated increasing interest in research careers by medical students, steady growth of the MD-PhD pool, and a new burst of activity in the "late bloomer" pool of MDs (individuals who choose research careers in medical school or in residency training), fueled by loan repayment programs that were created by the NIH in 2002. Several recent trends for more established physician-scientists have also suggested improvement. Although it is too early to assess the impact of these indicators on the long-term career pathway, the recent growth in activity in the physician-scientist career pipeline is an encouraging development. Continued funding of these new programs, coupled with sustained support for physician-scientists committed to the pathway, will be required to maintain these positive trends.
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                Author and article information

                Contributors
                + 41 22 372 90 36 , + 41 22 372 90 35 , stephane.cullati@hcuge.ch
                Journal
                BMC Med Res Methodol
                BMC Med Res Methodol
                BMC Medical Research Methodology
                BioMed Central (London )
                1471-2288
                4 May 2016
                4 May 2016
                2016
                : 16
                : 50
                Affiliations
                [ ]Division of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH–1211, Geneva 14, Switzerland
                [ ]Division of Anesthesia, Department of Anesthesiology, Pharmacology and Intensive Care, Geneva University Hospitals, Geneva, Switzerland
                [ ]Department of Gynecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland
                [ ]Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
                Article
                151
                10.1186/s12874-016-0151-1
                4855713
                27145883
                4dc6ce6a-2191-41e0-b70b-a58007b37fd6
                © Cullati et al. 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 26 August 2015
                : 26 April 2016
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2016

                Medicine
                clinical research,difficulties,barriers,medical researchers,research protocols,switzerland
                Medicine
                clinical research, difficulties, barriers, medical researchers, research protocols, switzerland

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