With the rising number of randomized clinical trials (RCTs) on gastric cancer (GC), there is a significant amount of research waste (eg, unpublished data, inadequate reporting, or avoidable design limitations), necessitating improvements in research design and data reuse, according to a cross-sectional study published in JAMA Network Open.
RCTs have made important contributions to the advancement of treatment for gastric cancer; however, wasteful RCTs use resources while still increasing risks to participants. With increasing incidence of treatment-resistant GC subtypes, minimizing research waste is necessary to ensure that new treatments are appropriately, safely, and effectively translated into clinical practice.
The amount of research waste in GC RCTs has not yet been examined. Therefore, researchers in China analyzed characteristics of GC RCTs performed over the past 20 years, concentrating on the presence of research waste and potential targets for improvement.
Using the keywords “gastric cancer”, investigators searched ClinicalTrials.gov for phase 3 or 4 RCTs registered from January 2000 to December 2019. A total of 262 GC RCTs were identified, which increased from 25 trials in 2000 to 2004 to 97 trials in 2015 to 2019. For RCTs of targeted therapy or immunotherapy, the proportion of studies increased from 0 trials in 2000 to 2004 to 36 trials in 2015 to 2019. Multicenter RCTs were significantly higher in non-Asian regions than in Asian regions (50/71 RCTs vs 96/191 RCTs, respectively; P =.004).
An analysis of research waste included 137 RCTs, of which 81 were published and had full text available for review. Among the published RCTs, 65 were adequately reported while 63 had avoidable design defects. Additionally, 119 RCTs had 1 or more features of research waste. Study settings that included blinding, a greater number of participants (≥200 participants), and external funding support were associated with lower odds of research waste. Thirty-five RCTs were referenced in guidelines, and 18 had their prospective data reused.
Investigators acknowledge that the quantification of research waste is complex and cannot be limited to only the elements included in this study. Additionally, researchers did not include RCTs from other country-specific and region-specific registries in their analysis, which may have limited its applicability.
“These findings suggest that there is room for improvement in research design, research implementation, results publication, and reuse of prospective data,” concluded the authors.
Lu J, Xu BB, Shen LL, et al. Characteristics and research waste among randomized clinical trials in gastric cancer. JAMA Network Open. 2021;4(9):e2124760. Doi: 10.1001/jamanetworkopen.2021.24760