Sarah Cannon Research Institute, Nashville, TN.
American Society of Clinical Oncology, Alexandria, VA.
JCO Oncol Pract. 2021 Jan;17(1):41-51. doi: 10.1200/OP.20.00821. Epub 2021 Jan 6.
Feasibility assessments (FAs) are important to establish site capabilities to conduct clinical trials and their suitability for specific trials. However, current FA methods used by biotechnology and pharmaceutical (biotech-pharma) trial sponsors and contract research organizations (CROs) are costly, inefficient, unnecessarily burdensome, and resource intensive. These methods delay trial start-up, act as a barrier to site participation, and ultimately reduce timely patient access to clinical trials and novel treatments.
An ASCO Task Force was convened to assess the specific burdens and challenges with FAs and to develop recommendations to improve their efficiencies and effectiveness. Stakeholders (including trial sites, biotech-pharma sponsors, and CROs) provided insights into challenges and offered solutions through two surveys and an in-person meeting. The Task Force used the feedback to formulate consensus recommendations to improve FAs for oncology clinical trials.
Three key recommendations were identified for application across all biotech-pharma sponsored trials: (1) implement a streamlined and uniform FA process across trials and sponsors; (2) minimize and standardize questions; and (3) leverage technology to centralize FAs, facilitate communications, and reduce redundancies.
There is an urgency to improve the current FA process, which is costly, inconsistent, inefficient, labor intensive, and of uncertain effectiveness. All stakeholders stand to benefit from implementing these recommendations, which aim to minimize burdens and ensure that more trial sites and patients have timely access to oncology clinical trials. To have meaningful impact, adoption and consistent execution of these recommendations across all trials, sponsors, CROs, and sites are essential.
可行性评估（FA）对于确定开展临床试验的场所能力及其对特定试验的适宜性至关重要。然而，生物技术和制药（biotech-pharma）试验赞助商和合同研究组织（CRO）目前使用的 FA 方法既昂贵又低效，不必要地增加了负担，且资源密集。这些方法会延迟试验启动，成为站点参与的障碍，并最终减少患者及时获得临床试验和新疗法的机会。
美国临床肿瘤学会（ASCO）专门成立了一个工作组，以评估 FA 所带来的具体负担和挑战，并提出改进其效率和效果的建议。利益相关者（包括试验站点、biotech-pharma 赞助商和 CRO）通过两次调查和一次现场会议，提供了对挑战的见解并提出了解决方案。工作组利用反馈信息制定了共识建议，以改善肿瘤学临床试验的 FA。
确定了适用于所有 biotech-pharma 赞助试验的三项关键建议：（1）在所有试验和赞助商中实施简化和统一的 FA 流程；（2）最小化并标准化问题；（3）利用技术集中 FA，促进沟通，并减少重复。
目前的 FA 流程既昂贵、不一致、低效、劳动密集且效果不确定，因此迫切需要加以改进。所有利益相关者都将从实施这些建议中受益，这些建议旨在减轻负担，并确保更多的试验站点和患者能够及时获得肿瘤学临床试验。为了产生有意义的影响，所有试验、赞助商、CRO 和站点都必须采用并一致执行这些建议。
