Impact and perceptions of mandatory tumor biopsies for correlative studies in clinical trials of novel anticancer agents
Impact and perceptions of mandatory tumor biopsies for correlative studies in clinical trials of novel anticancer agents
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DOI：
10.1200/jco.2005.03.4496
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发表时间：
2006-10-20
影响因子：
45.3
通讯作者：
Siu, Lillian L.
中科院分区：
文献类型：
--
作者：
Agulnik, Mark;Oza, Amit M.;Siu, Lillian L.
目的评估患者、医生和机构审查委员会成员（IRBs）对强制性连续肿瘤活检获取相关研究组织的影响和看法。患者和方法补充的，自我管理的问卷分发给之前接受过一系列研究相关活检（tp）的试验患者，先前诊断但未进行研究相关活检（CPs）的临床患者，加拿大的学术医学肿瘤学家（MOs）和附属学术中心的irb。结果14名TPs中有72%应答，325名CPs中有265名应答（82%），209名MOs中有137名应答（66%），291名irb中有142名应答（49%）。22%的cp可接受5% - 10%的主要活检并发症风险，但只有1%的MOs或irb可接受。30%的tp和45%的cp在活检前报告了焦虑。超过82%的MOs或irb认为，患者在活检前至少会有边缘性焦虑。在患者中，84%的人同意将他们的样本用于其他不相关的研究，75%的人同意进行基因检测。几乎所有的mo和86%的irb都认为要求进行额外的无关研究测试是合乎道德的。在基因检测方面，82%的MOs和72%的irb会要求进行基因检测。尽管几乎所有的mo和irb都看到了活检的价值，但他们的可接受风险阈值较低，并且他们比患者预期更多的相关焦虑。大多数患者回忆说，他们倾向于忍受他们的活组织检查，并伴有平均水平的焦虑，并且会允许他们的标本进行研究目的的测试。
PurposeTo assess the impact and perceptions of patients, physicians, and institutional review board members ( IRBs) on the issue of mandatory serial tumor biopsies to acquire tissues for correlative studies.Patients and MethodsComplementary, self-administered questionnaires were circulated to trial patients who had previously undergone serial research-related biopsies (TPs), clinic patients who had prior diagnostic but not research-related biopsies (CPs), academic medical oncologists in Canada (MOs), and IRBs at the affiliated academic centers.ResultsTen (72%) of 14 TPs, 265 (82%) of 325 CPs, 137 (66%) of 209 MOs, and 142 (49%) of 291 IRBs responded. A 5% to 10% risk of a major biopsy complication was acceptable to 22% of CPs but only to 1% of MOs or IRBs. Anxiety was reported by 30% of TPs and 45% of CPs before their biopsies. More than 82% of MOs or IRBs believed the average patient would have at least borderline anxiety before their biopsy. Among the patients, 84% would authorize their samples for additional unrelated research and 75% would agree to genetic testing. Nearly all MOs and 86% of IRBs considered it ethical to request for additional unrelated research testing. With respect to genetic testing, 82% of MOs and 72% of IRBs would request it.ConclusionAlthough nearly all MOs and IRBs see the value in the biopsy, their threshold for acceptable risk is lower and they anticipate more associated anxiety than patients. Most patients recalled a tendency to tolerate their biopsies well with an average associated anxiety, and would allow their specimens to be tested for research purposes.