Clinical trials report publications

Electronic publishing is relatively new and is not yet in any standardized form. It is important to understand, however, the main classes of electronic publication, before taking the big step of committing your clinical trial report to it. Only then can the central question be answered for that clinical trial Would electronic publication make these data more easily available to the audience that can best use them (Geddes, 1999) ... 

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. 

NIMH (2005). Treatment Research in Mental Illness Improving the Nation s Public Mental Health Care through NIMH Funded Interventions Research. Report of the National Advisory Mental Health Council s Workgroup on Clinical Trials. Washington, D.C. 

Despite the anecdotal nature and sometimes poor documentation, publication of case reports in journals remains one of the most useful primary sources of information on ADRs. ADR reports in the literature can be identified in several different ways. Prepublication manuscripts describing a spontaneous case report or an event from a clinical trial are sometimes provided by authors to the manufacturer of the drug and the regulatory authority in that country. Pharmaceutical companies are required to be aware of the literature as to the safety of their approved therapeutic products, and are assumed (by law) to be cognizant of such. 

In recent years there have been a range of recommendations regarding the structure of publications how they should be laid out and what they should contain. These have usually been in the form of checklists and all of this has been encapsulated within the CONSORT statement (Moher et al. (2001) and Altman et al. (2001)). CONSORT is an acronym for Consolidated Standards of Reporting Trials and increasingly many medical journals have adopted this guidance in terms of requiring their clinical trial publications to conform to it. There is a web site which provides up-to-date information and helpful resources and examples WWW. consort- statement.org. 

Gillings D and Koch G (1991) The application of the principle of intention-to-treat analysis of clinical trials Drug Information Journal, 25, 411-424 Greenwood M (1926) The errors of sampling of the survivorship tables Reports on Public Health and Statistical Subjects, No. 33, Appendix 1. London HMSO Grieve AP (2003) The number needed to treat a useful clinical measure or a case of the Emperor s new clothes Pharmaceutical Statistics, 2, 87-102 Haybittle JL (1971) Repeated assessment of results in clinical trials of cancer treatment British Journal of Radiology, 44, 793-797... 

Guidelines for reporting clinical trials in clinical publications are provided by the Consolidated Standards of Reporting Trials (CONSORT) group (see... 

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