More than half of the initially reported positive trials were found to be false-positive for overall survival.
Dr. Shen continued: “Our study shows that reducing false positive errors by imposing more stringent statistical threshold in Phase III trials is not likely to be practically feasible.
Rethink the process that leads to the decision of moving a new therapy to Phase III testing to begin with. More research is needed in this regard.”
“Our study highlights the need to more efficiently identify which new therapies merit Phase III testing,” said lead researcher Changyu Shen, PhD, Associate Professor at Harvard Medical School at the time this study was conducted.
“In order to sustain the rate of innovation in cancer therapeutics and ensure that our patients have access to effective yet affordable therapies, the clinical trial pipeline in oncology must be efficient and accurate. Our work shows that in the past ten years, this has not been the case.”
Most of the trials in the current study focused on lung, breast, gastrointestinal, and hematologic cancers; trials with fewer than 100 participants were excluded, meaning rare cancer types were less likely to be included. These are mostly two-arm studies of an interventional regimen compared with a control treatment.
“This paper shows that a lot of drugs with ‘positive’ Phase III trials may have a smaller ultimate benefit than was expected, and that changing the threshold for statistical significance is not a quick fix,” said Elizabeth A. Handorf, PhD, Associate Research Professor, Fox Chase Cancer Center, who was not involved in this research.
“I think it highlights the need for more efficient study designs, like adaptive trials, and clear definitions of what makes an effect clinically meaningful.”
Source: Medindia
For all the latest Health News Click Here
For the latest news and updates, follow us on Google News.
Denial of responsibility! NewsBit.us is an automatic aggregator around the global media. All the content are available free on Internet. We have just arranged it in one platform for educational purpose only. In each content, the hyperlink to the primary source is specified. All trademarks belong to their rightful owners, all materials to their authors. If you are the owner of the content and do not want us to publish your materials on our website, please contact us by email – [email protected]. The content will be deleted within 24 hours.
