Lemech Charlotte, Dua Divyanshu, Newmark Joshua, Saggese Matilde, Simmons Emily, Spiliopoulou Paulina, Arkenau Hendrik-Tobias
Sarah Cannon Research Institute, London, UK.
Oncology. 2015;88(2):95-102. doi: 10.1159/000368161. Epub 2014 Oct 14.
Research biopsies are increasingly incorporated into phase I oncology trials resulting in ethical and logistical challenges for patients and clinicians. Patients' understanding and willingness to undergo these biopsies are crucial.
Over 12 months, we administered a questionnaire comprising three sections: demographics and previous cancer therapy, understanding of phase I trials and personalized medicine, and understanding of biopsies and associated risks.
Out of 56 patients approached, 47 patients completed the questionnaire. Overall, the patients were well informed about the concepts of personalized medicine and 89% (n = 42) were aware that early phase clinical trials aim to define a dose and explore side effects of new drugs. Interestingly, 76% (n = 36) expected early phase trials to improve symptoms, quality of life and survival. Offering hope and feeling in control of their treatment were important components for 80% (n = 38) and 57% (n = 27), respectively. The majority of this highly selective patient cohort understood the concept of research biopsies, with 59% (n = 28) willing to have a fresh research biopsy for trial participation. Although 72% (n = 34) felt that research biopsies should be optional, only 19% (n = 9) would not participate in a clinical trial with mandatory biopsies. Compared to diagnostic biopsies, the patients were less likely to accept associated risks with research biopsies.
As research biopsies are crucial to many components of the drug development process, our study provides evidence for patients' overall willingness to undergo research biopsies for trial purposes. A consent process tailored to the biopsy site may help patients weigh up the associated risks versus benefits.
研究性活检越来越多地被纳入肿瘤I期试验，给患者和临床医生带来了伦理和后勤方面的挑战。患者对这些活检的理解和接受意愿至关重要。
在12个月的时间里，我们发放了一份包含三个部分的问卷：人口统计学信息和既往癌症治疗情况、对I期试验和个性化医疗的理解、对活检及相关风险的理解。
在接触的56名患者中，47名患者完成了问卷。总体而言，患者对个性化医疗的概念有充分了解，89%（n = 42）的患者知道早期临床试验旨在确定新药剂量并探索其副作用。有趣的是，76%（n = 36）的患者期望早期试验能改善症状、提高生活质量并延长生存期。对80%（n = 38）的患者来说，获得希望和感觉能掌控自己的治疗分别是重要因素，对57%（n = 27）的患者来说也是如此。这个高度选择性的患者群体中的大多数理解研究性活检的概念，59%（n = 28）愿意为参与试验进行新的研究性活检。尽管72%（n = 34）的患者认为研究性活检应该是可选择的，但只有19%（n = 9）的患者不会参加有强制性活检的临床试验。与诊断性活检相比，患者不太愿意接受研究性活检的相关风险。
由于研究性活检对药物研发过程的许多环节至关重要，我们的研究为患者总体上愿意为试验目的接受研究性活检提供了证据。根据活检部位量身定制的同意程序可能有助于患者权衡相关风险与益处。
