Prospective evaluation of cancer clinical trial accrual patterns: Identifying potential barriers to enrollment
Prospective evaluation of cancer clinical trial accrual patterns: Identifying potential barriers to enrollment
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DOI：
10.1200/jco.2001.19.6.1728
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发表时间：
2001-03-15
影响因子：
45.3
通讯作者：
Lam, KS
中科院分区：
文献类型：
--
作者：
Lara, PN;Higdon, R;Lam, KS
目的：良好的癌症临床试验对于改善患者结局至关重要。不幸的是，只有3%的新癌症患者参加了临床试验。癌症临床试验中的患者应计的障碍，必须确定和克服，以增加患者participation.Materials和方法：我们前瞻性地跟踪因素，可能会影响患者在加州大学戴维斯癌症中心的癌症临床试验中的应计。肿瘤学家看到新的门诊病人被要求完成问卷调查，病人的特点和医生的决策，病人的资格，协议的可用性，和病人的意见参与。统计分析wets进行相关这些参数与随后的协议accumulation.Results：有276可评估的患者。在初次访视时，医生没有考虑在38%（105/276）的患者中进行临床试验，主要是因为认为方案不可用和性能状态不佳。医生考虑62%（171/276）的患者参加临床试验。其中，只有53%（91/171）有一个适当的协议可用于疾病的部位和阶段。有可用方案的90例患者中有76例（84%）符合特定研究的合格标准。76例患者中只有39例（51%）同意参加癌症临床试验，总体累积率为14%（39/276）。其余患者（37/76，49%）尽管符合入选标准，但拒绝参加试验。最常见的原因是希望接受其他治疗（34%），远离癌症中心（13%），患者拒绝透露原因（11%）和保险拒绝（8%）。与拥有政府资助保险的患者相比，拥有私人保险的患者参加临床试验的可能性较小（OR，0.34; P = 0.03; 95%CI，0.13至0.9）。结论：癌症临床试验累积的障碍可以前瞻性地识别并在未来研究的开发和实施中解决，这可能会导致更稳健的临床试验招募。有必要调查患者对临床试验过程和第三方支付者作用的看法。(C)2001年，美国临床肿瘤学会。
Purpose: Well-conducted cancer clinical trials are essential for improving patient outcomes. Unfortunately, only 3% of new cancer patients participate in clinical trials. Barriers to patient accrual in cancer clinical trials must be identified and overcome to increase patient participation.Materials and Methods: We prospectively tracked factors that potentially affected patient accrual into cancer clinical trials at the University of California Davis Cancer Center. Oncologists seeing new outpatients were asked to complete questionnaires regarding patient characteristics and the physician's decision-making on patient eligibility, protocol availability, and patient opinions on participation. Statistical analysis wets performed to correlate these parameters with subsequent protocol accrual.Results: There were 276 assessable patients. At the initial visits, physicians did not consider clinical trials in 38% (105/276) of patients principally because of a perception of protocol unavailability and poor performance status. Physicians considered 62%(171/276) of patients for participation in clinical trials. Of these, only 53% (91/171) had an appropriate protocol available for site and stage of disease. Seventy-six of 90 patients (84%) with available protocols met eligibility criteria for a particular study. Only 39 of 76 patients (51%) agreed to participate in cancer clinical trials, for an overall accrual rate of 14% (39/276). The remainder (37/76, 49%) declined trial participation despite meeting eligibility criteria. The most common reasons were a desire for other treatment (34%), distance from the cancer center (13%), patient refusal to disclose reason (11%), and insurance denial (8%). Patients with private insurance were less likely to enroll in clinical trials compared to those with government-funded insurance (OR, 0.34; P = .03; 95% CI, 0.13 to 0.9).Conclusion: Barriers to cancer clinical trial accrual can be prospectively identified and addressed in the development and conduct of future studies, which may potentially lead to more robust clinical trials enrollment. Investigation of patient perceptions regarding the clinical trials process and the role of third party-payers is warranted. (C) 2001 by American Society of Clinical Oncology.