Table 1_Profiles of research waste in randomized clinical trials comparing de-escalation and escalation strategies for breast cancer treatment.doc

Escalation studies were more likely to have a palliative intent (71.2%) and a double-blind design (42.4%). Heterogeneity among the three study types was observed across the three components of research waste as well as study discontinuation. Overall, 113 of the 240 studies (47.1%) demonstrated research waste.

After adjusting for study characteristics such as design and discontinuation, escalation studies were independently associated with an increased risk of research waste compared to de-escalation studies (odds ratio, 4.337; 95% confidence interval, 1.165–18.567; P = 0.028).</p>Conclusion<p>A substantial burden of research waste was observed among phase 2 to 4 breast cancer treatment studies. The burden of research waste varied across study types, highlighting the need for tailored strategies to mitigate waste.

Given the limited number of de-escalation studies, these exploratory findings require further validation.</p>