Publishing clinical trials journal

The first solution is the prospective promulgation of a set of criteria that every author must meet. Many journals publish their own specific guidelines or criteria, and these do not differ greatly in qualitative terms. In the practicality of publishing clinical trials, the following would be typical ... 

This chapter has three objectives. First, it is necessary to discuss the ethics and desirability of publishing clinical trials, and the biases that may be involved with that process. Second, junior pharmaceutical physicians may benefit from some discussion of classic parts of an orthodox clinical trial report in a peer-reviewed journal, and some clues for effective oral presentations. Third, alternative forms of publication are discussed, including isolated abstracts and posters, electronic publication and press releases. The scope of this chapter is strictly formal publications regulatory documents (which are typically not published and are a different form of clinical trials reporting) and marketing materials are dealt with elsewhere. A summary and prospectus closes this chapter. 

In the decade that has passed since our article was published, the dust has settled around the issue of meta-analysis. It is no longer considered a controversial procedure. Meta-analyses of clinical trials are now routinely published in all of the top medical journals, and the National Institute for Health and Clinical Excellence (NICE), which publishes the treatment guidelines that are used by the NHS, crafts recommendations on the basis of meta-analyses that it conducts. Nevertheless, the editors were right about our article being controversial. Although some scholars in the field were persuaded by our analyses, others were sceptical, to put it mildly.2 The sceptics knew that antidepressants worked - if we had found otherwise, we must have done something wrong. Certainly there were other clinical trials of antidepressants beyond those that we had included in our analyses. Surely an analysis of those studies would point to a different conclusion. 

Editorial, A Double-Edged Sword , 2008.1 should also note that Nature, which is the primary journal of the Nature Publishing Group, responded to our meta-analysis with an excellent editorial on 6 March 2008. Citing the difficulties we had in obtaining access to complete data, they advocated a mandatory database that would provide access to the results of all trials clinical trials that are undertaken, not just those that are published. 

The primary purpose of this chapter is to review the structure-activity relationships (SAR) of non-peptide kappa opioid agonists and antagonists from the viewpoint of a medicinal chemist. It is intended to present an account of work in this area published in journals and in patents from 1985 up to the end of 1990. During the late 1980 s there was a significant increase in the literature on kappa opioids and this has resulted in several publications which, at the time of writing, have not been previously reviewed. Three pharmaceutical companies, Upjohn, Parke-Davis and Zambeletti (SB-Italy), have progressed kappa agonists into clinical trials, so it seems an appropriate and opportune time to review the preclinical data. 

Extensive tables of data will accompany the regulatory application so that the regulators can nm an independent analysis. In contrast, only limited data are published in journals. The editor and the reviewer, when provided with the scientific paper to be published, are seldom provided with adequate data to allow a detailed critique. For the manufacturer, the findings from clinical trials form the basis of what is said about the efficacy, safety and quality of a new medicine... 

The technique of randomization was pioneered in the field of agriculture (plants too show considerable individual variation) by Sir Ronald Fisher, a visionary statistician. It is generally acknowledged that the first randomized clinical trial, conducted in the 1940s, was a study evaluating the use of streptomycin in treating tuberculosis conducted by the (British) Medical Research Council Streptomycin in Tuberculosis Trials Committee. The results were published in the British Medical Journal in 1948. 

There are two components to evidence-based medicine and two related sets of responsibilities. The first component is clinical research. Clinical research is a scientific endeavor that provides evidence concerning potential therapeutic interventions. This book has focused on one particular therapeutic intervention, drug therapy. Once clinical trials have been conducted, the evidence obtained is published in clinical communications in journals. Everyone involved in clinical research has the responsibility to provide the best possible evidence in this manner. As noted throughout the book, this includes all aspects of clinical research study design, experimental methodology and clinical operations, analysis and interpretation, and also accurate and complete representation of study findings in clinical communications as discussed in Section 13.6. 

In 1992, the results of a landmark study by Czeizel A and Dudas I were published in the New England Journal of Medicine. Using a carefully controlled double-blind protocol (considered the gold standard by which clinical trials of new pharmaceuticals are routinely conducted), these investigators found that 0.8 mg day of folic acid (a water-soluble B vitamin) in a multivitamin preparation prevented spina bifida and anencephalus in the Hungarian women in their study. A subsequent study by Werler M and associates of Boston University (published in... 

Thus, there are multiple ways in which publication bias may be created by study sponsors, publicists, medical writers and those who control journal content. Clinical trial registries still do not exist in any comprehensive fashion. Those constructing meta-analyses from published studies should beware. 

Clinical Infectious Diseases—This journal, formerly named Reviews of Infectious Diseases, is an official publication of the IDSA. Articles are primarily directed at the diagnosis and treatment of infectious diseases, including clinical trials. Frequently, State of the Art articles are published that summarize current therapy of a particular infection. In addition, IDSA guidelines for the treatment of infectious diseases are published in this journal. 

Sponsors typically publish the results of important clinical trials in clinical communications in medical journals, and present the results at scientific conferences. As for the preparation of regulatory documentation, scientific communications depend heavily on the discipline of Statistics. Piantadosi (2005) made the following comment about publishing clinical communications ... 

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