How to Build a Successful Phase I Clinical Trials Unit: Lessons Based on the MD Anderson Cancer Center Experience.
作者信息
Kurzrock Razelle, Hong David
机构信息
Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.
WIN Consortium, Paris, France.
出版信息
J Immunother Precis Oncol. 2024 Aug 19;7(3):142-149. doi: 10.36401/JIPO-23-243. eCollection 2024 Aug.
Abstract
摘要
相似文献
1
How to Build a Successful Phase I Clinical Trials Unit: Lessons Based on the MD Anderson Cancer Center Experience.如何打造一个成功的I期临床试验单元：基于MD安德森癌症中心经验的教训
J Immunother Precis Oncol. 2024 Aug 19;7(3):142-149. doi: 10.36401/JIPO-23-243. eCollection 2024 Aug.
2
SAFE™ Initiative: A Step Closer to Positive Safety Culture and Improved Patient Experience.SAFE™ 倡议：向积极的安全文化和改善患者体验迈进了一步。
Cureus. 2022 Aug 29;14(8):e28554. doi: 10.7759/cureus.28554. eCollection 2022 Aug.
3
Bayesian clinical trials at The University of Texas MD Anderson Cancer Center: An update.德克萨斯大学MD安德森癌症中心的贝叶斯临床试验：最新进展。
Clin Trials. 2019 Dec;16(6):645-656. doi: 10.1177/1740774519871471. Epub 2019 Aug 26.
4
History of preoperative therapy for pancreatic cancer and the MD Anderson experience.胰腺癌术前治疗的历史和 MD 安德森的经验。
J Surg Oncol. 2021 May;123(6):1414-1422. doi: 10.1002/jso.26394.
5
Survival of patients with metastatic leiomyosarcoma: the MD Anderson Clinical Center for targeted therapy experience.转移性平滑肌肉瘤患者的生存情况：MD安德森临床中心的靶向治疗经验
Cancer Med. 2016 Dec;5(12):3437-3444. doi: 10.1002/cam4.956. Epub 2016 Nov 23.
6
Lessons learned from independent central review.独立中央审查的经验教训。
Eur J Cancer. 2009 Jan;45(2):268-74. doi: 10.1016/j.ejca.2008.10.031.
7
Clinical Trial Characteristics and Barriers to Participant Accrual: The MD Anderson Cancer Center Experience over 30 years, a Historical Foundation for Trial Improvement.临床试验特征与受试者招募障碍：MD安德森癌症中心30年的经验，试验改进的历史基础
Clin Cancer Res. 2017 Mar 15;23(6):1414-1421. doi: 10.1158/1078-0432.CCR-16-2439. Epub 2017 Mar 8.
8
The Surgical Legacy of Randolph Lee Clark Jr, MD: First Surgeon-in-Chief and Director of University of Texas MD Anderson Cancer Center I. Training and Surgical Practice Before Recruitment to University of Texas MD Anderson Hospital.兰道夫·李·克拉克 Jr，医学博士的外科遗产：德克萨斯大学 MD 安德森癌症中心的第一任外科主任和主任 I. 在被招募到德克萨斯大学 MD 安德森医院之前的培训和外科实践。
Ann Surg Oncol. 2021 Sep;28(9):4782-4793. doi: 10.1245/s10434-020-09511-5. Epub 2021 Jan 19.
9
Clinical characteristics and outcomes of pediatric oncology patients with aggressive biology enrolled in phase I clinical trials designed for adults: the university of Texas MD anderson cancer center experience.入组针对成人设计的I期临床试验的具有侵袭性生物学行为的儿科肿瘤患者的临床特征及预后：德克萨斯大学MD安德森癌症中心的经验
Oncoscience. 2014 Jul 27;1(7):522-530. doi: 10.18632/oncoscience.68.
10
Scientific Summary from the Morgan Welch MD Anderson Cancer Center Inflammatory Breast Cancer (IBC) Program 10 Anniversary Conference.摩根·韦尔奇MD安德森癌症中心炎性乳腺癌（IBC）项目十周年会议的科学总结。
J Cancer. 2017 Oct 9;8(17):3607-3614. doi: 10.7150/jca.21200. eCollection 2017.
引用本文的文献
1
Tracking a decade of phase I clinical trials in Italy: trends and insights from national and european registries amid regulatory change.追踪意大利十年的一期临床试验：监管变革背景下国家和欧洲注册机构的趋势与见解
Front Pharmacol. 2025 Aug 29;16:1661186. doi: 10.3389/fphar.2025.1661186. eCollection 2025.
本文引用的文献
1
Clinical trial design in the era of precision medicine.精准医学时代的临床试验设计。
Genome Med. 2022 Aug 31;14(1):101. doi: 10.1186/s13073-022-01102-1.
2
Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial.在全球启动III期试验的时间表：APHINITY试验的亚组分析。
Ecancermedicalscience. 2022 Apr 29;16:1379. doi: 10.3332/ecancer.2022.1379. eCollection 2022.
3
Real-world data from a molecular tumor board demonstrates improved outcomes with a precision N-of-One strategy.分子肿瘤委员会的真实世界数据表明，采用精准 N-of-One 策略可改善预后。
Nat Commun. 2020 Oct 2;11(1):4965. doi: 10.1038/s41467-020-18613-3.
4
Review of precision cancer medicine: Evolution of the treatment paradigm.精准肿瘤医学述评：治疗范式的演变。
Cancer Treat Rev. 2020 Jun;86:102019. doi: 10.1016/j.ctrv.2020.102019. Epub 2020 Mar 31.
5
Clinical Trial Characteristics and Barriers to Participant Accrual: The MD Anderson Cancer Center Experience over 30 years, a Historical Foundation for Trial Improvement.临床试验特征与受试者招募障碍：MD安德森癌症中心30年的经验，试验改进的历史基础
Clin Cancer Res. 2017 Mar 15;23(6):1414-1421. doi: 10.1158/1078-0432.CCR-16-2439. Epub 2017 Mar 8.
6
Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual.在专门的临床试验单位修改临床研究基础设施：试验开发、启动及受试者招募评估
Clin Cancer Res. 2017 Mar 15;23(6):1407-1413. doi: 10.1158/1078-0432.CCR-16-1936. Epub 2016 Nov 16.
7
Cancer Therapy Directed by Comprehensive Genomic Profiling: A Single Center Study.基于全面基因组分析的癌症治疗：单中心研究。
Cancer Res. 2016 Jul 1;76(13):3690-701. doi: 10.1158/0008-5472.CAN-15-3043. Epub 2016 May 18.
8
Analysis of regional timelines to set up a global phase III clinical trial in breast cancer: the adjuvant lapatinib and/or trastuzumab treatment optimization experience.乳腺癌全球 III 期临床试验设立区域时间表分析：辅助拉帕替尼和/或曲妥珠单抗治疗优化经验。
Oncologist. 2013;18(2):134-40. doi: 10.1634/theoncologist.2012-0342. Epub 2013 Jan 28.
9
Personalized medicine in a phase I clinical trials program: the MD Anderson Cancer Center initiative.个体化医学在 I 期临床试验项目中的应用：MD 安德森癌症中心的计划。
Clin Cancer Res. 2012 Nov 15;18(22):6373-83. doi: 10.1158/1078-0432.CCR-12-1627. Epub 2012 Sep 10.
10
A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies.紧迫感评估：评估临床试验开发时间与癌症治疗评估计划（NCI-CTEP）赞助研究累积表现之间的关系。
Clin Cancer Res. 2010 Nov 15;16(22):5557-63. doi: 10.1158/1078-0432.CCR-10-0133. Epub 2010 Nov 9.
Zotero 插件