Peer reviews, clinical trials

PDQ Physician Data Query. PDQ is an online database developed and maintained by the National Cancer Institute. Designed to make the most current, credible, and accurate cancer information available to health professionals and the public, PDQ contains peer-reviewed summaries on cancer treatment, screening, prevention, genetics, and supportive care a registry of cancer clinical trials from around the world and directories of physicians, professionals who provide genetics services, and organizations that provide cancer care. Most of this information is available on the CancerNet Web site, and more specific information about PDQ can be found at http //cancemet.nd.nih.gov/pdq.html. [NIH]... 

Modern medical research expects the proposed procedures and protocols of clinical trials to be submitted for peer review and that the human study subjects involved are provided with trial information before freely consenting to participate in that clinical trial. 

Most efficacy trials with reboxetine have so far only been published in review articles ( 178). Most of these articles did not have peer review and do not contain the full details concerning methodology or results. This fact limits the ability to accurately determine its relative efficacy and tolerability. In short-term (4 to 8 weeks), placebo-controlled clinical trials, reboxetine produced a response (defined as at least a 50% reduction in severity scores) in 56% to 74% of patients. These results were statistically superior to placebo in most studies. Reboxetine was also found to be as effective as imipramine and desipramine in four double-blind, randomized, active-controlled (but not placebo-controlled) studies involving more than 800 outpatients or inpatients with major depression. Reboxetine produced equivalent antidepressant response rates compared with fluoxetine in two clinical trials, one of which was also placebo-controlled. However, reboxetine was reported to have improved social motivation and behavior more than fluoxetine as assessed by the newly developed Social Adaptation Self-Evaluation Scale. In all of the studies, reboxetine had a similar time (i.e., 2 to 3 weeks) to onset of the antidepressant efficacy as do other antidepressants. 

When preclinical studies are conducted in house or are reported in peer-reviewed journals and intended to support clinical trials, they should be well-controlled and designed to answer specific toxicological questions. The data should also be available in sufficient detail to allow an independent review of the studies. Ideally study designs include not only efficacy but toxicological endpoints such as defined clinical laboratory parameters, macroscopic, and microscopic evaluation of tissues. 

The federal government has had some insight into the need for a federal office to oversee dissemination of information on alternative medicine. Previously known as the Office of Alternative Medicine (established in 1992), the National Center for Complementary and Alternative Medicine (NCCAM) was established in 1998 as part of the National Institutes of Health. The mission of the NCCAM is to give the public reliable information on the safety and effectiveness of complementary and alternative medicine, with an emphasis on clinical trial sponsorship.The budget of the NCCAM has grown from 2 million in 1992 to almost 70 million in 2000, and almost half the budget is mandated to fund peer-reviewed grants. The NCCAM also helps to disseminate information to... 

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... 

THE CLASSIC COMPONENTS OF A CLINICAL TRIAL REPORT IN A PEER-REVIEWED JOURNAL... 

The classic components of a clinical trial report in a peer-reviewed journal... 

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. 

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