Department of Medical Oncology, Ioannina University Hospital, Greece.
Cancer Treat Rev. 2012 Oct;38(6):560-5. doi: 10.1016/j.ctrv.2011.12.001. Epub 2011 Dec 29.
The comparison of clinical cancer research characteristics across the Atlantic and their evolution over time have not been studied to date.
We collected oral presentations on breast, lung and colorectal cancer at ASCO (n=506) and ESMO (n=239) Congresses in years 2000-2010.
EU-originated research constituted 52% of all ASCO presentations while US-research 26.7% of ESMO Congress presentations. Industry sponsorship was reported in 24.8% of ASCO vs. 31.8% of ESMO Congress trials. ASCO-presented trials were larger with longer follow-up periods but were blinded less often. ESMO-presented trials used Event-Free Survival (EFS, 38.1%) and Surrogate (18.4%) primary endpoints and reported positive primary endpoints (65%) more often than ASCO-presented trials. Interim analysis resulted in discontinuation of a trial more often at ASCO Congress (8.3% vs. 3.2%). ASCO Congress-presented research was more often published (69.2% vs. 59.8% at ESMO) at higher impact factor journals. Strong trends over the decade were seen for more frequent industry sponsorship, blinded design, larger sample size, early interim discontinuation, use of EFS endpoints and biomarker evaluation.
Cancer clinical research is a complex scientific activity with common global but also distinct characteristics at the two sides of the Atlantic.
迄今为止，尚未对大西洋两岸的癌症临床研究特征进行比较，也未对其随时间的演变进行研究。
我们收集了 2000 年至 2010 年 ASCO（n=506）和 ESMO（n=239）大会上关于乳腺癌、肺癌和结直肠癌的口头报告。
欧盟来源的研究构成了 ASCO 所有报告的 52%，而美国研究构成了 ESMO 大会报告的 26.7%。ASCO 报告的试验中有 24.8%有工业赞助，而 ESMO 大会报告的试验中有 31.8%有工业赞助。ASCO 报告的试验规模更大，随访时间更长，但盲法应用较少。ESMO 报告的试验使用无事件生存（EFS，38.1%）和替代（18.4%）主要终点，并报告阳性主要终点（65%）的频率高于 ASCO 报告的试验。中期分析导致 ASCO 大会（8.3%比 3.2%）试验更频繁地终止。ASCO 大会报告的研究更常在高影响因子期刊上发表（69.2%比 ESMO 大会的 59.8%）。在过去十年中，我们看到了更频繁的行业赞助、盲法设计、更大的样本量、早期中期终止、使用 EFS 终点和生物标志物评估等强烈趋势。
癌症临床研究是一项复杂的科学活动，在大西洋两岸具有共同的全球特征，但也具有独特的特征。
