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The Article Alert for the week of March 23, 2015 (sample articles)
Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, Califf RM. Compliance with Results Reporting at ClinicalTrials.gov. NEJM. 2015 Mar 12;372(11):1031-9. PMID: 25760355.
Background: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results.
Methods: Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period.
Results: From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions.
Conclusions: Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic institutions. (Funded by the Clinical Trials Transformation Initiative and the NIH.).
- FREE FULL TEXT: http://www.nejm.org/doi/full/10.1056/NEJMsa1409364
- DOI: http://dx.doi.org/10.1056/NEJMsa1409364
- PubMed: http://www.ncbi.nlm.nih.gov/pubmed/25760355
Harris SP, Gould R, Fujiura G. Enhancing rigor and practice of scoping reviews in social policy research: Considerations from a worked example on the Americans with Disabilities Act. Work. 2015 Jan 1;50(2):323-34. PMID: 25503885.
Background: There is increasing theoretical consideration about the use of systematic and scoping reviews of evidence in informing disability and rehabilitation research and practice. Indicative of this trend, this journal published a piece by Rumrill, Fitzgerald and Merchant in 2010 explaining the utility and process for conducting reviews of intervention-based research. There is still need to consider how to apply such rigor when conducting more exploratory reviews of heterogeneous research.
Objectives: This article explores the challenges, benefits, and procedures for conducting rigorous exploratory scoping reviews of diverse evidence.
Methods: The article expands upon Rumrill, Fitzgerald and Merchant's framework and considers its application to more heterogeneous evidence on the impact of social policy.
Results: A worked example of a scoping review of the Americans with Disabilities Act is provided with a procedural framework for conducting scoping reviews on the effects of a social policy. The need for more nuanced techniques for enhancing rigor became apparent during the review process.
Conclusions: There are multiple methodological steps that can enhance the utility of exploratory scoping reviews. The potential of systematic consideration during the exploratory review process is shown as a viable method to enhance the rigor in reviewing diverse bodies of evidence.
Slaughter L, Friis Berntsen C, Brandt L, Mavergames C. Enabling Living Systematic Reviews and Clinical Guidelines through Semantic Technologies. D-Lib. 2015 Jan-Feb;21(1/2).
In clinical medicine, secondary research that produces systematic reviews and clinical practice guidelines is key to sound decision-making and quality care. Having machine-readable primary study publications, namely the methods and results of published human clinical trials can greatly improve the process of summarizing and synthesizing knowledge in medicine. In this short introduction to the problem, we provide a brief review of the related literature on various efforts to produce semantic technologies for sharing and reusing content from clinical investigations (RCTs and other clinical primary studies). Using an illustrative case, we outline some of the necessary metadata that needs to be captured in order to achieve some initial automation in authorship of systematic reviews and clinical guidelines. In addition, we list desiderata that we believe are needed to reduce the time and costs of maintaining these documents. These include linking provenance information to a much longer scientific investigation lifecycle, one that incorporates a single study's role all the way through its use in clinical guideline recommendations for patient treatments.