Fallowfield L, Ratcliffe D, Souhami R
Department of Oncology, University College London Medical School, U.K.
Eur J Cancer. 1997 Nov;33(13):2221-9. doi: 10.1016/s0959-8049(97)00253-0.
Progress in the assessment and introduction of new treatments is impeded by the failure to recruit eligible patients into clinical trials. Little is known about the attitudes of U.K. cancer specialists towards trial participation, therefore a postal survey was conducted of 553 British clinical, medical and surgical oncologists. A 45-item questionnaire was returned by 357 clinicians (65% response rate). Although 353 (99%) of respondents stated that they were participating in trials, median 3 (range 0-62), 269 (75%) of clinicians were entering fewer than 50% of eligible patients. Differences were seen between professional groups within oncology; medical oncologists placed more emphasis on research than on clinical activities, felt greater pressure to participate in trials and were more likely to value being known by national and international colleagues than did surgeons or clinical oncologists. Surgeons were more likely to rely on clinical experience rather than enter patients into a trial but were more likely to keep patients on study following relapse. The survey identified constraints imposed by the healthcare system which impede trial participation including lack of time, communication difficulties and conflicts between the role of clinician and scientist. Such factors need consideration when trials are designed. Comparison of British data with those from the U.S. clinicians were broadly similar. The few differences found suggest that the more protocol-driven culture of the U.S. might encourage recruitment and a greater commitment to keep patients on trials.
由于未能招募到符合条件的患者参加临床试验,新疗法的评估和引入工作受到了阻碍。对于英国癌症专家对试验参与的态度知之甚少,因此对553名英国临床、医学和外科肿瘤学家进行了邮寄调查。357名临床医生(回复率65%)返回了一份包含45个条目的问卷。尽管353名(99%)受访者表示他们正在参与试验,中位数为3项(范围0 - 62),但269名(75%)临床医生纳入的符合条件患者不到50%。肿瘤学专业组之间存在差异;与外科医生或临床肿瘤学家相比,医学肿瘤学家更重视研究而非临床活动,感到参与试验的压力更大,并且更看重被国内外同行知晓。外科医生更倾向于依赖临床经验而非让患者参加试验,但在患者复发后更有可能让其继续参与研究。该调查确定了医疗保健系统对试验参与造成的限制,包括时间不足、沟通困难以及临床医生和科学家角色之间的冲突。在设计试验时需要考虑这些因素。将英国的数据与美国临床医生的数据进行比较,结果大致相似。发现的少数差异表明,美国更受方案驱动的文化可能会鼓励招募患者,并更坚定地让患者继续参与试验。