Moorcraft Sing Yu, Marriott Cheryl, Peckitt Clare, Cunningham David, Chau Ian, Starling Naureen, Watkins David, Rao Sheela
The Royal Marsden NHS Foundation Trust, London, UK.
The Royal Marsden NHS Foundation Trust, Sutton, UK.
Trials. 2016 Jan 9;17:17. doi: 10.1186/s13063-015-1105-3.
Recruitment to clinical trials can be challenging and slower than anticipated. This prospective patient survey aimed to investigate the proportion of patients approached about a trial who agree to participate, their motivations for trial participation and their views on aspects of cancer research.
Patients who had been approached about participation in any clinical trials in the Gastrointestinal and Lymphoma Unit at the Royal Marsden were invited to complete a questionnaire. The statistical analysis is mainly descriptive, with percentages being reported. Univariate logistic regression analysis was used to determine any associations between patient characteristics and patient responses.
From August 2013-July 2014, 276 patients received 298 clinical trial patient information sheets and were asked to complete the questionnaire. The majority of patients (263 patients, 88 %) consented to a clinical trial and 249 of the 263 patients (95 %) completed the questionnaire. Multiple factors influenced decisions to participate in clinical trials, with patients stating that the most important reasons were that the trial offered the best treatment available and that the trial results could benefit others. Of the 249 questionnaire respondents, 78 % would donate their tissue for genetic research, 75 % would consider participating in studies requiring a research biopsy and 75 % felt that patients should be informed of trial results. Patients treated with palliative intent and those who had received multiple lines of treatment were more willing to consider research biopsies. Of the patients approached about a clinical trial of an investigational medicinal product, 48-50 % would have liked more information on the study drugs/procedures.
The majority of patients approached about a clinical trial consented to one or more trials. Patients' motivations for trial participation included potential personal benefit and altruistic reasons. A high proportion of patients were willing to donate tissue for research and to consider trials involving repeat biopsies. The majority of patients feel that participants should be informed of trial results and there is a group of patients who would like more detailed trial information.
招募患者参加临床试验可能具有挑战性，而且比预期的要慢。这项前瞻性患者调查旨在研究被邀请参加试验的患者中同意参与的比例、他们参与试验的动机以及他们对癌症研究各方面的看法。
邀请曾被邀请参与皇家马斯登医院胃肠和淋巴瘤科任何临床试验的患者填写问卷。统计分析主要为描述性分析，并报告百分比。采用单因素逻辑回归分析来确定患者特征与患者反应之间的任何关联。
2013年8月至2014年7月，276名患者收到298份临床试验患者信息表，并被要求填写问卷。大多数患者（263名患者，88%）同意参加一项临床试验，263名患者中的249名（95%）完成了问卷。多种因素影响参与临床试验的决定，患者表示最重要的原因是该试验提供了可用的最佳治疗方法，并且试验结果可能使他人受益。在249名问卷受访者中，78%愿意捐赠组织用于基因研究，75%会考虑参与需要进行研究性活检的研究，75%认为患者应该被告知试验结果。接受姑息治疗的患者以及接受过多种治疗方案的患者更愿意考虑进行研究性活检。在被邀请参加研究性药品临床试验的患者中，48% - 50%希望获得更多关于研究药物/程序的信息。
大多数被邀请参加临床试验的患者同意参加一项或多项试验。患者参与试验的动机包括潜在的个人利益和利他原因。很大一部分患者愿意捐赠组织用于研究，并考虑参与涉及重复活检的试验。大多数患者认为应该告知参与者试验结果，并且有一部分患者希望获得更详细的试验信息。
