Barriers and facilitators to enrollment in cancer clinical trials - Qualitative study of the perspectives of clinical research associates

Barriers and facilitators to enrollment in cancer clinical trials - Qualitative study of the perspectives of clinical research associates
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DOI:
10.1002/cncr.10862
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发表时间:
2002-10-01
期刊:
影响因子:
6.2
通讯作者:
Aspelund, F
Aspelund, F
中科院分区:
医学1区
文献类型:
--
作者:
Grunfeld, E;Zitzelsberger, L;Aspelund, F

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背景文献继续报告癌症临床试验的累积率较低。以前的研究主要是检查医生相关或患者相关的障碍。临床研究助理(CRAB)有一个独特的视角,已经探索得很少。本研究征求了CRAB对应计制的障碍和促进因素的意见。焦点小组在加拿大安大略的八个三级癌症中心中的六个举行。两名作者转录了会议录音带并进行了内容分析。确定了紧急主题。这些主题是由代表性的报价从成绩单说明。作为障碍或促进因素的因素分为医生相关,患者相关,或系统相关的因素。CRAB确定医生的态度,病人参与的主要医生相关的障碍。CRAB讨论了与患者参与相关的障碍、促进因素和修改因素。患者似乎比过去更了解试验,并且愿意参与。系统因素被认为对累积能力的影响最大。CRAB确定了不断增加的试验和药物需求,以及紧张的试验时间线。时间被视为一种日益减少的资源。更大的需求不仅影响特定的临床试验的收益,而且影响癌症中心和医院对试验的一般支持。CRAB认为,在卫生保健资源减少的环境下,更大的需求对应计费用产生了负面影响。因此,将潜在有益的基础研究成果转化为临床实践的重要过程被减缓。
BACKGROUND. The literature continues to report low rates of accrual to cancer clinical trials. Previous studies have examined principally physician-related or patient-related barriers. Clinical research associates (CRAB) have a unique perspective on enrollment that has been explored very little. This study sought the views of CRAB on barriers and facilitators to accrual.METHODS. Focus groups were held at six of eight tertiary cancer centers in Ontario, Canada. Audiotapes of sessions were transcribed and subjected to content analysis by two of the authors. Emergent themes were identified. These themes are illustrated by representative quotes taken from the transcripts.RESULTS. Factors that acted as barriers or facilitators were classified into physician-related, patient-related, or system-related factors. CRAB identified physician attitudes regarding patient participation as the principal physician-related barrier. Barriers, facilitators, and modifying factors that were related to patient involvement were discussed by CRAB. Patients seemed more knowledgeable about trials than in the past and were willing to participate. System factors were considered to have the greatest impact on the ability to accrue. CRAB identified increasing trial and pharmaceutical demands coupled with tight trial time lines. Time was seen as a diminishing resource. Greater demands not only affect specific clinical trial accrual but also affect general support for trials in the cancer center and hospital.CONCLUSIONS. The impact of greater demands in a climate of decreasing health care resources is perceived by CRAB as having a negative affect on accrual. Consequently, the important process of translating potentially beneficial basic research findings into clinical practice is slowed.