Peer-reviewed journals, publishing clinical trials

Although information about dietary supplements is widely available on the Internet, it is usually provided by product distributors, and is designed to sell products rather than to provide objective information about product efficacy and toxicity. Even reviews of dietary supplements in journals, newsletters, books, and electronic databases can be biased or incorrect. In compiling information to be included in Herbal Products Toxicology and Clinical Pharmacology, Second Edition, emphasis was placed on the use of original studies published in reputable, peer-reviewed journals. Older studies, as well as more current literature, were utilized for completeness, with an emphasis on newer literature and double-blind, controlled trials. Where appropriate, information was obtained... 

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. 

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. Once clinical trials have been conducted, results are published in appropriate peer-reviewed journals. Everyone involved in cUnical research has the responsibility to provide the best possible evidence in this manner (a topic discussed in the following chapter with particular attention to safety results). 

While it is extranely important that all clinical trials are designed appropriately, conducted meticulously, and analyzed appropriately and correctly, it is equally important that they are reported appropriately. Published reports, typically papers in peer-reviewed journals, are used by physicians practicing evidence-based medicine to decide if the treatment discussed in a paper is an appropriate one for a given... 

NICOLINO AMBROSINO is Director of Respiratory Unit, Cardio-Thoracic Department, University Hospital of Pisa, Italy, Director of Pulmonary Rehabilitation and Weaning Center, Volterra, Italy and is or was Professor at the Universities of Pisa, Pavia, Florence, and Trieste, Italy. Professor Ambrosino s research and clinical activity has been devoted to Respiratory Critical Care, Pulmonary Rehabilitation and Home Respiratory Care. He contributed to the development of the use of non-invasive mechanical ventilation techniques in acute and chronic respiratory failure, with several clinical trials and original experimental studies. Results of his studies have been published in more than 155 peer-reviewed international journals. The former Head of Pulmonary Rehabilitation Working Croup of the European Respiratory Society (ERS), Dr. Ambrosino is a member of various editorial boards of several international journals, has written over 60 books and chapters, 200 articles, and has spoken at over 100 international conferences. 

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