The Impact of Incorporating Clinical Relevance on the Feasibility of Clinical Trials
Therapeutic Innovation & Regulatory Science, ISSN: 2168-4790, Vol: 42, Issue: 2, Page: 99-106
2008
- 4Citations
- 14Captures
Metric Options: Counts1 Year3 YearSelecting the 1-year or 3-year option will change the metrics count to percentiles, illustrating how an article or review compares to other articles or reviews within the selected time period in the same journal. Selecting the 1-year option compares the metrics against other articles/reviews that were also published in the same calendar year. Selecting the 3-year option compares the metrics against other articles/reviews that were also published in the same calendar year plus the two years prior.
Example: if you select the 1-year option for an article published in 2019 and a metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019. If you select the 3-year option for the same article published in 2019 and the metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019, 2018 and 2017.
Citation Benchmarking is provided by Scopus and SciVal and is different from the metrics context provided by PlumX Metrics.
Example: if you select the 1-year option for an article published in 2019 and a metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019. If you select the 3-year option for the same article published in 2019 and the metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019, 2018 and 2017.
Citation Benchmarking is provided by Scopus and SciVal and is different from the metrics context provided by PlumX Metrics.
Metrics Details
- Citations4
- Citation Indexes4
- CrossRef4
- Captures14
- Readers14
- 14
Article Description
In the past, data from placebo-controlled trials have been analyzed to demonstrate only a statistically significant treatment difference. However, the most important drawback of this classical approach is that looking at the presence or absence of an effect ignores the issue of effect size (ie, clinical relevance). A statistically significant treatment effect gives only the information that the treatment difference is not zero but does not provide information about the clinical relevance. Therefore, this practice has been criticized by regulatory authorities and the use of point estimates and corresponding confidence intervals has been recommended assessing additionally whether the observed treatment effect is also of clinical relevance. In this article, we focus on the implications of different criteria of defining clinical relevance, and we illustrate the consequences for clinical trials in patients with chronic obstructive pulmonary disease when the St. George's Respiratory Questionnaire is used as a symptomatic clinical endpoint. In conclusion, we demonstrate that the point estimate to exceed an a priori-defined threshold is an adequate method for incorporating clinical relevance required in addition to statistical significance. © 2008, Drug Information Association. All rights reserved.
Bibliographic Details
http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84996199146&origin=inward; http://dx.doi.org/10.1177/009286150804200201; http://link.springer.com/10.1177/009286150804200201; http://journals.sagepub.com/doi/pdf/10.1177/009286150804200201; http://link.springer.com/content/pdf/10.1177/009286150804200201.pdf; http://link.springer.com/article/10.1177/009286150804200201/fulltext.html
Springer Science and Business Media LLC
Provide Feedback
Have ideas for a new metric? Would you like to see something else here?Let us know