Overcoming Age-Dependent Barriers to Early Phase Trials

描述(由申请人提供) 这项建议是对RFA CA-03-501《克服早期临床试验的障碍》的回应，该报告将在NCI指定的科罗拉多大学综合癌症中心(UCCC)进行。这项提案的重点是确定和开发方法，以最大限度地减少肿瘤学早期临床试验中年龄相关的登记障碍。随着越来越多的基于机制的治疗方法正在进行临床开发，由于早期试验的强度通常包括多个生物、临床和药理学终点，因此招募老年或年轻患者变得更加困难。同样，以社区为基础的肿瘤学实践也遇到了转介这些患者的困难，因为缺乏足够的基础设施来为患者提供交通、维持频繁的后续访问、处理和处理研究标本以及传输数据。本提案涉及的两个障碍是围绕青少年/青壮年和老年患者群体。尽管每个障碍相关，但除了促进和维持社区转诊和参与早期试验的初步战略外，每个障碍都包含一个初始调查工具，以评估每个患者群体的感知障碍是什么。列入了成果评估，目的是根据调查的中期结果调整权责发生制战略。在早期临床试验中增加老年和年轻患者的收益可能带来的附带好处包括：1)改进给药策略和改善对新药物的耐受性，2)更早参与，从而增强社区肿瘤学家对新药物的熟悉，以及3)生物和药理学标本中更广泛的年龄代表。这项建议的最终目标是制定战略，以克服可能被输出到其他癌症中心的年龄相关障碍；并为进一步研究参与临床试验的年龄相关障碍奠定基础。

DESCRIPTION (provided by applicant) This proposal is in response to the RFA CA-03-501 entitled "Overcoming Barriers to Early Phase Clinical Trials" to be conducted at the NCI-designated University of Colorado Comprehensive Cancer Center (UCCC). The focus of this proposal is to identify and develop methods to minimize age-dependent barriers to enrollment on early-phase clinical trials in oncology. With the increasing numbers of mechanism-based therapies undergoing clinical development, it is becoming more difficult to enroll the older or younger-aged patients due to the intensity of the early-phase trials that often incorporate multiple biological, clinical and pharmacological endpoints. Likewise, community-based oncology practices experience difficulty referring these patients due to the lack of adequate infrastructure to provide the patients with transportation; to maintain frequent follow-up visits; to handle and process research specimens; and to transmit data. The two barriers approached in this proposal are centered around the adolescent/ young adult and geriatric patient populations. Although related, each barrier incorporates an initial survey tool to assess what the perceived barriers are from each patient population in addition to preliminary strategies to facilitate and maintain community referral and participation in the early-phase trials. Outcomes assessments have been included with the intent of redirecting accrual strategies according to interim results of surveys. Collateral benefits that may be expected from enhancing accrual of the older and younger patient in early clinical trials include: 1) refinement of dosing strategies and improved tolerability with new agents, 2) earlier participation and thus enhanced familiarity of community oncologists with new agents, and 3) broader age representation in biological and pharmacological specimens. The ultimate goals of this proposal are to formulate strategies for overcoming age-dependent barriers that may be exported to other Cancer Centers; and to form the basis for further work in age-dependent barriers to clinical trial participation.