Transfer of Statistical Innovations of the 1990s-2000s in Oncology to the Biomedical Literature

Introduction: Innovations in the fields of clinical studies require time to generate and disseminate new knowledge. We aimed to specifically explore lag times between the introduction and widespread use of innovative statistical methods in oncology using the competing risks and phase I model-based clinical trials settings as examples. Methods: First, we defined a set of closed articles for each setting based on two princeps papers (Gray, Annals of Statistics 1998 for the competing risks setting and O Quigley et al., Biometrics 1990 for the phase I setting). Secondly, we retrieved from the web of science all citations of the papers included in these sets. Each journal was classified as applied, semi-applied or methodological. Results: A total of 6,727 citations for the competing risks setting and 2,639 citations for the phase I setting were found. Time to reach 25 citations was 6.2 years for the paper from Gray and 4.5 years for the Fine and Gray paper, while it ranged from 3.4 years up to at least 20.1 years and not reached for 6 papers from the competing risks setting. The vast majority (91%) of the citing papers for the competing risks setting originated from applied journals. In contrast, less than half (44%) of the citing papers for the phase I setting were published in applied journals. Conclusion: Statistical innovations in the competing risks setting have been widely diffused in the medical literature unlike the model-based designs for phase I trials, which are still seldom used 30 years after publication.