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      Modeling the dissemination and uptake of clinical trials results

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          A select set of highly cited publications from the National Institutes of Health (NIH) HIV/AIDS Clinical Trials Networks was used to illustrate the integration of time interval and citation data, modeling the progression, dissemination, and uptake of primary research findings. Following a process marker approach, the pace of initial utilization of this research was measured as the time from trial conceptualization, development and implementation, through results dissemination and uptake. Compared to earlier studies of clinical research, findings suggest that select HIV/AIDS trial results are disseminated and utilized relatively rapidly. Time-based modeling of publication results as they meet specific citation milestones enabled the observation of points at which study results were present in the literature summarizing the evidence in the field. Evaluating the pace of clinical research, results dissemination, and knowledge uptake in synthesized literature can help establish realistic expectations for the time course of clinical trials research and their relative impact toward influencing clinical practice.

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          Most cited references 24

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          Is Open Access

          The answer is 17 years, what is the question: understanding time lags in translational research

          This study aimed to review the literature describing and quantifying time lags in the health research translation process. Papers were included in the review if they quantified time lags in the development of health interventions. The study identified 23 papers. Few were comparable as different studies use different measures, of different things, at different time points. We concluded that the current state of knowledge of time lags is of limited use to those responsible for R&D and knowledge transfer who face difficulties in knowing what they should or can do to reduce time lags. This effectively ‘blindfolds’ investment decisions and risks wasting effort. The study concludes that understanding lags first requires agreeing models, definitions and measures, which can be applied in practice. A second task would be to develop a process by which to gather these data.
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            Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials.

            Medical evidence may be biased over time if completion and publication of randomized efficacy trials are delayed when results are not statistically significant. To evaluate whether the time to completion and the time to publication of randomized phase 2 and phase 3 trials are affected by the statistical significance of results and to describe the natural history of such trials. Prospective cohort of randomized efficacy trials conducted by 2 trialist groups from 1986 to 1996. Multicenter trial groups in human immunodeficiency virus infection sponsored by the National Institutes of Health. A total of 109 efficacy trials (total enrollment, 43708 patients). Time from start of enrollment to completion of follow-up and time from completion of follow-up to peer-reviewed publication assessed with survival analysis. The median time from start of enrollment to publication was 5.5 years and was substantially longer for negative trials than for results favoring an experimental arm (6.5 vs 4.3 years, respectively; P<.001; hazard ratio for time to publication for positive vs negative trials, 3.7; 95% confidence interval [CI], 1.8-7.7). This difference was mostly attributable to differences in the time from completion to publication (median, 3.0 vs 1.7 years for negative vs positive trials; P<.001). On average, trials with significant results favoring any arm completed follow-up slightly earlier than trials with nonsignificant results (median, 2.3 vs 2.5 years; P=.045), but long-protracted trials often had low event rates and failed to reach statistical significance, while trials that were terminated early had significant results. Positive trials were submitted for publication significantly more rapidly after completion than were negative trials (median, 1.0 vs 1.6 years; P=.001) and were published more rapidly after submission (median, 0.8 vs 1.1 years; P=.04). Among randomized efficacy trials, there is a time lag in the publication of negative findings that occurs mostly after the completion of the trial follow-up.
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                Author and article information

                Res Eval
                Res Eval
                Research Evaluation
                Oxford University Press
                September 2013
                30 May 2013
                30 May 2014
                : 22
                : 3
                : 179-186
                1Concept Systems, Inc., 136 East State Street, Ithaca, NY 14850-5546, 2Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, E2-112, Seattle, WA 98109-1024 and 3Division of Clinical Research, NIAID, NIH, 6700B Rockledge Drive, Room 1102, Bethesda, MD 20892-7609
                Author notes
                *Corresponding author. Email: srosas@
                © The Author 2013. Published by Oxford University Press. All rights reserved. For Permissions, please email:
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