VIEWPOINTS AND CONCERNS OF A CLINICAL-TRIAL PARTICIPANT
VIEWPOINTS AND CONCERNS OF A CLINICAL-TRIAL PARTICIPANT
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DOI：
10.1002/1097-0142(19941101)74:9
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发表时间：
1994-11-01
期刊：
影响因子：
6.2
通讯作者：
JOSEPH, RR
中科院分区：
文献类型：
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作者：
JOSEPH, RR
大多数执业肿瘤学家都致力于前瞻性临床试验的概念，但由于多种逻辑和感知障碍，实际上只有一小部分患者参与此类研究。医生担心的问题包括对安慰剂或“不治疗”随机分组的不适、对方案患者进行繁琐监测的负担以及担心让转诊医生不高兴。患者很难接受随机试验的不确定性，尤其是安慰剂组的试验。他们对与方案参与相关的额外访问和研究带来的不便和费用感到不满。知情同意文件通常很复杂，其意图会被患者误解。严格的资格要求虽然对于准确分析是必要的，但却会减少应计费用。方案的多样性、由此产生的优先顺序的必要性、常见肿瘤的 II 期研究的快速结束以及媒体强化的负面公众态度都是临床试验参与的重大障碍。增加应计费用对医生来说是一项艰巨的挑战。简化繁琐的数据收集、同意书和机构审查委员会程序将减少参与的意愿。最重要的是，医生必须是教育者，强调临床试验对患者及其家人、同事和公众的好处。
Most practicing oncologists are committed to the concept of prospective clinical trials but, because of multiple logistic and perceptual deterrents, actually enter only a small portion of their patients into such studies. Physician concerns include discomfort with placebo or ''no treatment'' randomizations, the burden of cumbersome monitoring of protocol patients, and fear of displeasing referring physicians. Patients have difficulty accepting the uncertainty of randomized trials, particularly those with a placebo arm. They resent the inconvenience and expense of extra visits and studies associated with protocol participation. Informed consent documents are often complex and their intent misconstrued by patients. Rigorous eligibility requirements, although necessary for accurate analysis, reduce accrual. Multiplicity of protocols, with the resulting necessity to prioritize, rapid closure of Phase II studies for common tumors, and negative public attitudes reinforced by the media are significant deterrents to clinical trial participation. Increasing accrual is a daunting challenge to the physician. Simplification of burdensome data collection, consent forms, and institutional review board procedures will reduce reluctance to participate. Most important, physicians must be educators, emphasizing the advantages of clinical trials to their patients and their families, their colleagues, and the public.