A Taxpayer-Funded Clinical Trials Registry and Results Database

It already exists within the US Food and Drug Administration, argues a former clinical reviewer of psychotropic drugs at the FD

What do the JAMA editors say when they discuss manuscripts that they are considering for publication? Developing a schema for classifying the content of editorial discussion

<p>Abstract</p> <p>Background</p> <p>In an effort to identify previously unrecognized aspects of editorial decision-making, we explored the words and phrases that one group of editors used during their meetings.</p> <p>Methods</p> <p>We performed an observational study of discussions at manuscript meetings at <it>JAMA</it>, a major US general medical journal. One of us (KD) attended 12 editorial meetings in 2003 as a visitor and took notes recording phrases from discussion surrounding 102 manuscripts. In addition, editors attending the meetings completed a form for each manuscript considered, listing the reasons they were inclined to proceed to the next step in publication and reasons they were not (DR attended 4/12 meetings). We entered the spoken and written phrases into NVivo 2.0. We then developed a schema for classifying the editors' phrases, using an iterative approach.</p> <p>Results</p> <p>Our classification schema has three main themes: science, journalism, and writing. We considered 2,463 phrases, of which 87 related mainly to the manuscript topic and were not classified (total 2,376 classified). Phrases related to science predominated (1,274 or 54%). The editors, most of whom were physicians, also placed major weight on goals important to JAMA's mission (journalism goals) such as importance to medicine, strategic emphasis for the journal, interest to the readership, and results (729 or 31% of phrases). About 16% (n = 373) of the phrases used related to writing issues, such as clarity and responses to the referees' comments.</p> <p>Conclusion</p> <p>Classification of editorial discourse provides insight into editorial decision making and concepts that need exploration in future studies.</p

The Intangible Magic of Celebrity Marketing

Drug industry insiders share their tips on using celebrities to market drugs and disease

Doing New Research? Don't Forget the Old

Nobody should do a new research study, says Clarke, without first systematically reviewing the literature. And journal editors should insist that all research papers are accompanied by an up-to-date systematic revie

Publication bias in clinical trials

This is the protocol for a review and there is no abstract. The objectives are as follows: To summarise evidence of publication bias for trials of health care interventions.Output Type: Protoco

Following 411 Cochrane Protocols to Completion: A Retrospective Cohort Study

Cochrane reviews are regarded as being scientifically rigorous and are increasingly used by a variety of stakeholders. However, factors predicting the publication of Cochrane reviews have never been reported. This is important because if a higher proportion of Cochrane protocols with certain characteristics (e.g., funding) are being published, this may lead to inaccurate decisions. We examined the frequency of published and unpublished Cochrane reviews and protocol factors that predict the publication of Cochrane reviews.Retrospective cohort study of Cochrane protocols published in 2000 (Issues 2 to 4) and 2001 (Issue 1). The publication status of these reviews was followed up to Issue 1, 2008 in The Cochrane Library. Survival analysis of the time from protocol publication to the first review publication and protocol factors predicting the time to publication was conducted. There were 411 new Cochrane protocols in the cohort. After excluding 39; 71/372 (19.1%) were unpublished and 301/372 (80.9%) were published as full Cochrane reviews at the time of study analysis (January 2008). The median time to publication was 2.4 years (range: 0.15 to 8.96). Multivariate analyses revealed that shorter time to publication was associated with the review subsequently being updated (hazard ratio, HR: 1.80 [95% confidence interval, CI: 1.39 to 2.33 years]) and longer time to publication was associated with the review having two published protocols, indicating changes to the review plan (HR: 0.33 [95% CI: 0.12 to 0.90 years]).Only about 80% Cochrane protocols were published as full reviews after over 8 years of follow-up. The median time to publication was 2.4 years and some reviews took much longer. Strategies to decrease time to publication should be considered, such as streamlining the review process, increased support for authors when protocol amendments occur, and better infrastructure for updating Cochrane reviews

Country development and manuscript selection bias: a review of published studies

BACKGROUND: Manuscript selection bias is the selective publication of manuscripts based on study characteristics other than quality indicators. One reason may be a perceived editorial bias against the researches from less-developed world. We aimed to compare the methodological quality and statistical appeal of trials from countries with different development status and to determine their association with the journal impact factors and language of publication. METHODS: Selection criteria: Based on the World Bank income criteria countries were divided into four groups. All records of clinical trials conducted in each income group during 1993 and 2003 were included if they contained abstract and study sample size. Data sources: Cochrane Controlled Trials Register was searched and 50 articles selected from each income group using a systematic random sampling method in years 1993 and 2003 separately. Data extraction: Data were extracted by two reviewers on the language of publication, use of randomization, blinding, intention to treat analysis, study sample size and statistical significance. Disagreement was dealt with by consensus. Journal impact factors were obtained from the institute for scientific information. RESULTS: Four hundred records were explored. Country income had an inverse linear association with the presence of randomization (chi2 for trend = 5.6, p = 0.02) and a direct association with the use of blinding (chi2 for trend = 6.9, p = 0.008); although in low income countries the probability of blinding was increased from 36% in 1993 to 46% in 2003. In 1993 the results of 68% of high income trials and 64.7% of other groups were statistically significant; but in 2003 they were 66% and 82% respectively. Study sample size and income were the only significant predictors of journal impact factor. CONCLUSION: The impact of country development on manuscript selection bias is considerable and may be increasing over time. It seems that one reason may be more stringent implementation of the guidelines for improving the reporting quality of trials on developing world researchers. Another reason may be the presumptions of the researchers from developing world about the editorial bias against their nationality

A specialist toxicity database (TRACE) is more effective than its larger, commercially available counterparts

A comparison of the retrieval precision and recall of a specialist bibliographic toxicity database (TRACE) with that of a wide range of commercial on-line databases indicated that the larger size and resources of the commercial databases did not, for a series of test queries, assure superior retrieval of relevant papers. The specialist database, in which document selection and indexing is undertaken by the same (in this case) expert toxicologists who subsequently use the database in their day-to-day work, achieved markedly better retrieval, using simpler search strategies, than the commercial databases. Small specialist databases may offer a valuable alternative to existing commercial databases