Statistical Power of Negative Randomized Controlled Trials Presented at American Society for Clinical Oncology Annual Meetings

Excerpts

Our survey of 423 negative clinical trials indicates that 55% of trials had too few participants to detect a medium effect size in favor of the experimental over the standard treatment arm for their primary end point with at least 80% statistical power. Although underpowered negative clinical trials have been widely reported in the general medical and subspecialty literature, there are few reports relating to trials evaluating treatment of cancer. A review of 22 negative randomized oncology trials published in major general medical or oncology journals during a 1-year period found that 16 trials (73%) lacked adequate statistical power to detect a 50% improvement in median survival in favor of the experimental arm.

Reference

Philippe L Bedard, Monika K Krzyzanowska, Melania Pintilie, Ian F Tannock “Statistical Power of Negative Randomized Controlled Trials Presented at American Society for Clinical Oncology Annual Meetings” (2007) DOI: 10.1200/jco.2007.11.3670

@Article{bedard2007,
  title = {Statistical Power of Negative Randomized Controlled Trials Presented at American Society for Clinical Oncology Annual Meetings},
  volume = {25},
  issn = {1527-7755},
  url = {http://dx.doi.org/10.1200/JCO.2007.11.3670},
  doi = {10.1200/jco.2007.11.3670},
  number = {23},
  journal = {Journal of Clinical Oncology},
  publisher = {American Society of Clinical Oncology (ASCO)},
  author = {Bedard, Philippe L and Krzyzanowska, Monika K and Pintilie, Melania and Tannock, Ian F},
  year = {2007},
  month = {aug},
  pages = {3482–3487}
}