Overcoming Age-Dependent Barriers to Early Phase Trials

描述（由申请人提供） 本提案是对RFA CA-03-501的回应，标题为“克服早期临床试验的障碍”，将在NCI指定的科罗拉多大学综合癌症中心（UCCC）进行。该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招募的年龄依赖性障碍。随着越来越多的基于机制的治疗正在进行临床开发，由于早期试验的强度，通常包含多个生物学、临床和药理学终点，因此招募老年或高龄患者变得越来越困难。同样，基于社区的肿瘤学实践也遇到了困难，因为缺乏足够的基础设施来为患者提供运输;保持频繁的随访;处理和处理研究标本;以及传输数据。本提案中涉及的两个障碍主要集中在青少年/年轻成人和老年患者人群。虽然相关，但每个障碍都包含一个初步调查工具，以评估每个患者人群的感知障碍，以及促进和维持社区转诊和参与早期试验的初步策略。列入了成果评估，目的是根据调查的中期结果调整应计战略。在早期临床试验中增加老年患者和年轻患者的入组预期可能带来的附带获益包括：1）改进给药策略并改善对新药的耐受性，2）更早参与，从而提高社区肿瘤学家对新药的熟悉程度，以及3）生物学和药理学标本中更广泛的年龄代表性。该提案的最终目标是制定克服年龄依赖性障碍的策略，这些策略可能会被输出到其他癌症中心;并为进一步研究参与临床试验的年龄依赖性障碍奠定基础。

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.