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Showing papers by "Steven N. Goodman published in 2011"


Journal ArticleDOI
TL;DR: In reports of RCTs published over 4 decades, fewer than25% of preceding trials were cited, comprising fewer than 25% of the participants enrolled in all relevant prior trials.
Abstract: Results: 227 meta-analyses were identified, comprising 1523 trials published from 1963 to 2004. The median prior research citation index was 0.21 (95% CI, 0.18 to 0.24), meaning that less than one quarter of relevant reports were cited. The median sample size citation index (0.24 [CI, 0.21 to 0.27]) was similar, suggesting that larger trials were not selectively cited. Of the 1101 RCTs that had 5 or more prior trials to cite, 254 (23%) cited no prior RCTs and 257 (23%) cited only 1. The median number of prior cited trials was 2, which did not change as the number of citable trials increased. The mean number of preceding trials cited by trials published after 2000 was 2.4, compared with 1.5 for those published before 2000 (P 0.001). Limitation: The investigators could not ascertain why prior trials were not cited, and noncited trials may have been taken into account in the trial design and proposal stages. Conclusion: In reports of RCTs published over 4 decades, fewer than 25% of preceding trials were cited, comprising fewer than 25% of the participants enrolled in all relevant prior trials. A median of 2 trials was cited, regardless of the number of prior trials that had been conducted. Research is needed to explore the explanations for and consequences of this phenomenon. Potential implications include ethically unjustifiable trials, wasted resources, incorrect conclusions, and unnecessary risks for trial participants.

125 citations


Journal ArticleDOI
TL;DR: The feasibility of detecting aberrant DNA methylation of some novel and known genes in the serum of lung cancer patients by using quantitative methylation-specific PCR is investigated and the six most promising genes are tested.
Abstract: Purpose: We investigated the feasibility of detecting aberrant DNA methylation of some novel and known genes in the serum of lung cancer patients. Experimental Design: To determine the analytic sensitivity, we examined the tumor and the matched serum DNA for aberrant methylation of 15 gene promoters from 10 patients with primary lung tumors by using quantitative methylation-specific PCR. We then tested this 15-gene set to identify the more useful DNA methylation changes in the serum of a limited number of lung cancer patients and controls. In an independent set, we tested the six most promising genes ( APC , CDH1 , MGMT , DCC , RASSF1A , and AIM1 ) for further elucidation of the diagnostic application of this panel of markers. Results: Promoter hypermethylation of at least one of the genes studied was detected in all 10 lung primary tumors. In majority of cases, aberrant methylation in serum DNA was accompanied by methylation in the matched tumor samples. In the independent set, using a single gene that had 100% specificity ( DCC ), 35.5% (95% CI: 25–47) of the 76 lung cancer patients were correctly identified. For patients without methylated DCC , addition of a logistic regression score that was based on the five remaining genes improved sensitivity from 35.5% to 75% (95% CI: 64–84) but decreased the specificity from 100% to 73% (95% CI: 54–88). Conclusion: This approach needs to be evaluated in a larger test set to determine the role of this gene set in early detection and surveillance of lung cancer. Clin Cancer Res; 17(13); 4494–503. ©2011 AACR .

125 citations


Journal ArticleDOI
TL;DR: This issue's study in this issue raises the specter of a new metabias that is similar to EMT, which poses unique challenges for comparative effectiveness research and evidence-based healthcare.
Abstract: Metabias poses unique challenges for comparative effectiveness research and evidence-based healthcare. Dechartres and colleagues' study in this issue raises the specter of a new metabias that is pa...

51 citations


Journal ArticleDOI
TL;DR: In older adults with low-grade WML, low DBP may not pose a risk for ischemic stroke, however, in high-gradeWML, IS risk may increase in DBP less than 69mmHg but is highest more than 80 mmHg.
Abstract: Background. The optimal blood pressure level to minimize the risk of ischemic stroke (IS) in older adults is undetermined. Cerebral white matter lesions (WML), prevalent in older adults, may be a marker for vulnerability to IS. We aimed at determining the relationship between diastolic blood pressure (DBP) levels and IS in the presence of WML.

13 citations


Journal ArticleDOI
TL;DR: One reward in being an editor is the opportunity to bring attention to important aspects of the field deserving of attention, in this case, that aspect is a person.
Abstract: One reward in being an editor is the opportunity to bring attention to important aspects of the field deserving of attention. In this case, that aspect is a person. Harry M. Marks, PhD, who was an Associate Editor of this journal since its reincarnation in 2004, friend, colleague, and a major thinker and ally to the field of clinical trials that most clinical trialists did not know they had. Harry lost his 5-year struggle with prostate cancer on January 25th, 2011. The journal will devote this space to describe and express its appreciation for his extraordinary and unusual contribution to scholarship in clinical trials. Steven Goodman

5 citations


Journal ArticleDOI
TL;DR: As a clinical trialist, some personal experiences and participation in the Cliveden conference led to a new appreciation of the methodological and conceptual challenges faced by those trying to improve medical systems.
Abstract: As a clinical trialist, I had thought that the methods I employed were far more challenging than those I had thought were needed for quality improvement. However, some personal experiences and participation in the Cliveden conference led me to a new appreciation of the methodological and conceptual challenges faced by those trying to improve medical systems.

4 citations