PMean » Research design

PMean: Make a loud mistake

pmean — Fri, 15 Feb 2019 18:00:25 +0000

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PMean: Think positively, what has research done for us

pmean — Wed, 23 Jan 2019 17:09:25 +0000

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Recommended: Complex Innovative Trial Designs Pilot Program

pmean — Thu, 13 Sep 2018 15:27:30 +0000

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Recommended: A Review of Published Analyses of Case-Cohort Studies and Recommendations for Future Reporting

pmean — Fri, 20 Jul 2018 16:11:39 +0000

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Recommended: How to increase value and reduce waste when research priorities are set

pmean — Mon, 25 Sep 2017 21:11:00 +0000

This is the first in a series of articles on reducing waste in research. It focuses on funding agencies and recommends that funders should support more work on making research replicable, be more transparent on how they set priorities, make sure that research proposals are justified through a systematic review of previous research, and encourage greater openness of research in progress to encourage collagoration. Other articles in this series cover research design, conduct, and analysis, regulation and management, inaccessible research, and incomplete reports of research.

Iain Chalmers, Michael B Bracken, Ben Djulbegovic, Silvio Garattini, Jonathan Grant, A Metin Gülmezoglu, David W Howells, John P A Ioannidis, Sandy Oliver. How to increase value and reduce waste when research priorities are set. Lancet 2014; 383: 156–65. Available at http://www.testingtreatments.org/wp-content/uploads/2014/03/1-Chalmers-et-al.-Paper-1.pdf.

Recommended: Randomized Controlled Trials in Health Insurance Systems

pmean — Thu, 21 Sep 2017 00:41:52 +0000

While researchers often use data from health insurance systems to conduct observational studies, the authors of this research paper point out that you can also conduct randomized trials as well. You can randomly assign different levels of insurance coverage and then get claims data to evaluate how much difference there is, if any, in the levels of coverage. This approach is attractive because you do not need a lot of resources, and you can very quickly get a very large sample size. Since insurance data is collected for administrative needs rather than research needs, you have to contend with inaccurate or incomplete data, potentially causing loss of statistical efficiency or producing biased results. The authors offer some interesting examples of actual studies, propose new potential studies, and offer general guidance on how to conduct a randomized trial from health insurance systems.

Choudhry NK. Randomized, Controlled Trials in Health Insurance Systems. N Engl J Med 2017 (Sept. 7); 377: 957-964. Available at http://www.nejm.org/doi/full/10.1056/NEJMra1510058.

Recommended: Notice of Revised NIH Definition of Clinical Trial

pmean — Wed, 13 Sep 2017 22:42:21 +0000

The NIH recently updated their definition of what a clinical trial is. Here is the link to the new definition. Also worth reviewing are an FAQ list, some case studies, some additional training resources, and blog posts on September 8, 2017 and September 11, 2017.

National Institutes of Health. Notice of Revised NIH Definition of “Clinical Trial”. Notice Number: NOT-OD-15-015. Available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html.

Recommended: Conducting Clinical Research

pmean — Sun, 12 Mar 2017 17:29:29 +0000

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This is a website associated with a very nice book on the pragmatic aspects of running a clinical trial. I came across this site because I was looking for a simple example of a letter to doctors asking them to help recruit patients for a clinical trial. This was in an appendix along with other nice examples of things like case report forms, serious adverse event forms, HIPAA consent template, etc. You can download a free PDF version of this book or you can buy a paper copy.

Judy Stone. Conducting Clinical Research. Available at http://www.conductingclinicalresearch.com/index.php.

Recommended: The Importance of Reproducible Research in High-Throughput Biology

pmean — Wed, 03 Aug 2016 18:28:29 +0000

I have not viewed this video yet, but have attended a similar talk and read a similar research paper by Keith Baggerly. His general message is that large biological and genetic experiments are sometimes designed so poorly as to invalidate the results. You can often discover these design flaws through a careful examination of the data sets themselves and their metadata. This process of uncovering design flaws is sometimes called “Forensic Statistics.”

Keith Baggerly (2010) The Importance of Reproducible Research in High-Throughput Biology. Case Studies in Forensic Bioinformatics. Available at http://videolectures.net/cancerbioinformatics2010_baggerly_irrh/.

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Recommended: Enrichment design studies should enhance signals of effectiveness.

pmean — Wed, 03 Aug 2016 18:17:20 +0000

I noticed several talks at the JSM 2016 on enrichment designs. I was only very vaguely familiar with what this meant, so I did a quick Google search. I found this very nice non-technical overview.

Robert Temple (2014) Enrichment design studies should enhance signals of effectiveness. http://www.fda.gov/Drugs/NewsEvents/ucm295054.htm.

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