Publishing of clinical trials

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. 

The procedures for assuring quality of clinical trials have evolved over the past 30 years, culminating in several published guidelines. There are three key documents - the GCP guidelines of the ICH, the Code of Federal Regulations (21 CFR) of the United States and the Declaration of Helsinki. " ... 

Guidelines for the conduct of clinical trials of pharmaceutical agents have been published (e.g., WHO, 1995), and internationally recognized EC Principles of Good Clinical Practice have been developed (EC,... 

The interest in the local routes of administration for immunotherapy (IT) has rapidly increased, and a large number of clinical trials have been published... 

Abramson and Starfield (2005) asked the right question in their article titled The Effect of Conflict of Interest on Biomedical Research and Clinical Practice Guidelines Can We Trust the Evidence in Evidence-Based Medicine Their answer is no. In reality, so-called evidence-based medicine is a concept largely owned by drug company advocates who are trying to compel the use of their patron s products. Abramson and Starfield referred to a British House of Common s report that found that approximately 75% of clinical trials published in The Lancet, the New England... 

In summary, in vivo and in vitro studies indicate that InsPg may have significant potential as an effective agent for the prevention and treatment of cancer. To the best of our knowledge, no published controlled clinical trials have examined the anticancer effect of InsPg. 

It should be noted that a recent, evidence-based, systematic review of published randomized clinical trials of therapy for toxoplasmic retinochoroiditis fitund only three studies that met the authors criteria for inclusion, two of which were carried out more than 35 years ago. Based on this evaluation the authors concluded that there was a lack of evidence to support routine antibiotic treatment for ocular toxoplasmosis, finding no evidence for a beneficial effect on the duration and severity of signs of the disease process. However, the preponderance of evidence supports the concept that appropriate antibiotic therapy is a community standard of care, which is bolstered by guidelines for treatment in many published sources, plus the responses of those practitioners recently surveyed about their preferred patterns of management of the condition. 

Friedman, L.M. Furberg, C.D. Basic study design. In Fundamentals of Clinical Trials, PSG Publishing Co., Inc. Littleton, MA, 1985 35-38. 

A meta-analysis of six published randomized clinical trials investigating glucosamine in OA up to and including 1999 demonstrated moderate to large effects. The authors concluded that even though these trials were associated with exaggerated estimates of benefit, it appeared that glucosamine did have efficacy in... 

An overview of clinical trials with a special diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine has been published (3). The vaccine contains as pertussis components purified filamentous hemagglutinin, pertactin, and genetically engineered pertussis toxin. The vaccine induces high and long-lasting immunity and is at least as efficacious as most whole-cell pertussis vaccines and similar in efficacy to the most efficacious acellular... 

The under-reporting of the results of clinical trials in patients with heart failure has been reviewed (7). Some trials that have been unpublished or published only in abstract or preliminary form have involved drugs with positive inotropic effects, such as the phosphodiesterase inhibitor vesnarinone (SEDA-23, 195), the beta-adrenoceptor partial agonist xamoterol, and the dopamine receptor agonist ibopamine. 

In principle, results of clinical trials should be published. Upon publication, the relevance of the results should be assessed, considering the significance of the disease as well as the clinical effort involved, and the associated financial costs of the procedure or measure investigated. It should be stated in the publication that this was a company-sponsored clinical trial and the sponsor must be mentioned. 

Thus, Lind illustrates some other aspects of clinical trials first, he had little academic kudos, although he was clearly qualified by experience and training (a requirement of trialists by law in the United States). Second, he did not publish his results rapidly. Third, his results were not implemented promptly in the interests of the public health. It is important to realize that these undesirable aspects of clinical trials persist to this day. 

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