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      Why Most Clinical Research Is Not Useful

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      PLoS Medicine
      Public Library of Science

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          Abstract

          John Ioannidis argues that problem base, context placement, information gain, pragmatism, patient centeredness, value for money, feasibility, and transparency define useful clinical research. He suggests most clinical research is not useful and reform is overdue.

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          Most cited references42

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          Surrogate end points in clinical trials: are we being misled?

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            Launching PCORnet, a national patient-centered clinical research network

            The Patient-Centered Outcomes Research Institute (PCORI) has launched PCORnet, a major initiative to support an effective, sustainable national research infrastructure that will advance the use of electronic health data in comparative effectiveness research (CER) and other types of research. In December 2013, PCORI's board of governors funded 11 clinical data research networks (CDRNs) and 18 patient-powered research networks (PPRNs) for a period of 18 months. CDRNs are based on the electronic health records and other electronic sources of very large populations receiving healthcare within integrated or networked delivery systems. PPRNs are built primarily by communities of motivated patients, forming partnerships with researchers. These patients intend to participate in clinical research, by generating questions, sharing data, volunteering for interventional trials, and interpreting and disseminating results. Rapidly building a new national resource to facilitate a large-scale, patient-centered CER is associated with a number of technical, regulatory, and organizational challenges, which are described here.
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              The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed

              Objectives To examine the reporting characteristics and methodological details of randomised trials indexed in PubMed in 2000 and 2006 and assess whether the quality of reporting has improved after publication of the Consolidated Standards of Reporting Trials (CONSORT) Statement in 2001. Design Comparison of two cross sectional investigations. Study sample All primary reports of randomised trials indexed in PubMed in December 2000 (n=519) and December 2006 (n=616), including parallel group, crossover, cluster, factorial, and split body study designs. Main outcome measures The proportion of general and methodological items reported, stratified by year and study design. Risk ratios with 95% confidence intervals were calculated to represent changes in reporting between 2000 and 2006. Results The majority of trials were two arm (379/519 (73%) in 2000 v 468/616 (76%) in 2006) parallel group studies (383/519 (74%) v 477/616 (78%)) published in specialty journals (482/519 (93%) v 555/616 (90%)). In both 2000 and 2006, a median of 80 participants were recruited per trial for parallel group trials. The proportion of articles that reported drug trials decreased between 2000 and 2006 (from 393/519 (76%) to 356/616 (58%)), whereas the proportion of surgery trials increased (51/519 (10%) v 128/616 (21%)). There was an increase between 2000 and 2006 in the proportion of trial reports that included details of the primary outcome (risk ratio (RR) 1.18, 95% CI 1.04 to 1.33), sample size calculation (RR 1.66, 95% CI 1.40 to 1.95), and the methods of random sequence generation (RR 1.62, 95% CI 1.32 to 1.97) and allocation concealment (RR 1.40, 95% CI 1.11 to 1.76). There was no difference in the proportion of trials that provided specific details on who was blinded (RR 0.91, 95% CI 0.75 to 1.10). Conclusions Reporting of several important aspects of trial methods improved between 2000 and 2006; however, the quality of reporting remains well below an acceptable level. Without complete and transparent reporting of how a trial was designed and conducted, it is difficult for readers to assess its conduct and validity.
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                Author and article information

                Journal
                PLoS Med
                PLoS Med
                plos
                plosmed
                PLoS Medicine
                Public Library of Science (San Francisco, CA USA )
                1549-1277
                1549-1676
                21 June 2016
                June 2016
                : 13
                : 6
                : e1002049
                Affiliations
                [1 ]Stanford Prevention Research Center, Department of Medicine and Department of Health Research and Policy, Stanford University School of Medicine, Palo Alto, California, United States of America
                [2 ]Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Palo Alto, California, United States of America
                Author notes

                The author is a member of the editorial board of PLOS Medicine.

                Wrote the first draft of the manuscript: JPAI. Contributed to the writing of the manuscript: JPAI. Agree with the manuscript’s results and conclusions: JPAI. The author has read, and confirms that he meets, ICMJE criteria for authorship.

                Article
                PMEDICINE-D-15-02756
                10.1371/journal.pmed.1002049
                4915619
                27328301
                68b8652e-b5b7-4a1a-9f2f-312cd88f5da1
                © 2016 John P. A. Ioannidis

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                Page count
                Figures: 0, Tables: 3, Pages: 10
                Funding
                The Meta-Research Innovation Center at Stanford (METRICS) is funded by a grant from the Laura and John Arnold Foundation ( http://www.arnoldfoundation.org). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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