Clinical Protocol and Data Management
临床方案和数据管理
基本信息
- 批准号:9924333
- 负责人:
- 金额:$ 22.86万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:
- 资助国家:美国
- 起止时间:至
- 项目状态:未结题
- 来源:
- 关键词:21 year oldAddressAfrican AmericanAmerican IndiansCancer CenterCancer Center Support GrantCancer PatientCatchment AreaChildClinicalClinical DataClinical ProtocolsClinical ResearchClinical TrialsConduct Clinical TrialsDataDevelopmentElderlyEnrollmentEnsureFemaleGoalsHispanicsInformation SystemsInstitutesInstitutionInterventionLeadMalignant Childhood NeoplasmMinorityMonitorNursing ResearchOklahomaParticipantPatient-Focused OutcomesPatientsPediatric OncologyPediatric Oncology GroupPoliciesPopulationQuality ControlReportingResearchResearch PersonnelResearch SupportRiskRuralRural PopulationSafetyServicesSiteTherapeutic TrialsTimeTrainingTranslational ResearchTribesUnderserved PopulationUninsuredUnited States National Institutes of HealthWomanbasecancer clinical trialcancer health disparityclinical trial participantdata integritydata managementdesignefficacy clinical trialimprovedimproved outcomeparticipant safetyprogramsrecruitsafety studysoundstandard of caretreatment trial
项目摘要
CLINICAL PROTOCOL AND DATA MANAGEMENT – ABSTRACT
A centralized Clinical Trials Office (CTO) oversees all Clinical Protocol and Data Management (CPDM)
functions at the Stephenson Cancer Center (SCC), with the goal of supporting SCC investigators in the design,
development, conduct and reporting of all aspects of clinical research in an efficient, compliant and
scientifically focused manner. CTO staff perform regulatory and compliance, data management, research
nursing and study coordination, information systems and data support, research finance, and admin support
functions to ensure timely initiation, conduct and completion of trials with effective quality control and training
functions. Over the past five years, the SCC has accrued 8,083 patients to clinical trials, including 2,531
enrollments to interventional treatment, 1,015 to other interventional and 4,537 to non-interventional trials. The
SCC's exceptional track record of accrual to NCTN interventional treatment trials led to its being designated an
NCTN Lead Academic Participating Site (LAPS) in 2014.
The SCC places the highest priority on ensuring the safety of subjects participating in clinical trials and on the
quality of data obtained from clinical and translational research. The SCC has a written Data and Safety
Monitoring Plan (DSMP) that describes the oversight of study conduct, participant safety and integrity of data
for all clinical trials at the SCC, and particularly for IITs and those studies for which a DSMP does not already
exist. A standing DSM Committee meets quarterly to fulfill this important monitoring function.
The SCC places a high priority on the recruitment and retention of women, minorities and other underserved
populations for clinical trial participation as a way to address Oklahoma's significant cancer health disparities.
The SCC has instituted a number of focused initiatives designed to accomplish this aim, with a particular focus
on recruiting the state's large and underserved American Indian (AI) population for clinical trial participation.
The SCC's AI Patient Navigation Program has served 1,554 AI cancer patients from 54 different tribes over the
past five years, helping to facilitate the enrollment of 343 AI patients to interventional and 263 to non-
interventional trials. Other initiatives have been implemented to promote the inclusion of rural, under- and
uninsured, African American, Hispanic, elderly and female patients on clinical trials.
The SCC is committed to the NIH Policy of including children (subjects less than 21 years of age) in all
appropriate clinical research supported by the NIH. A primary goal of the SCC's Pediatric Oncology
Department is recruiting and retaining children to participate in clinical trials as a way of advancing ideas and
raising the standard of care for this population. This group has maintained an active record in the design and
conduct of pediatric cancer clinical trials, both the Children's Oncology Group (COG) and IIT, to accomplish
this goal. It has consistently been in the top quartile of COG institutions for enrollment in therapeutic trials.
临床方案和数据管理-摘要
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Kathleen N. Moore其他文献
Extraperitoneal para-aortic lymph node evaluation for cervical cancer via pfannenstiel incision: technique and peri-operative outcomes.
通过 pfannenstiel 切口对宫颈癌进行腹膜外主动脉旁淋巴结评估:技术和围手术期结果。
- DOI:
10.1016/j.ygyno.2007.11.043 - 发表时间:
2008 - 期刊:
- 影响因子:4.7
- 作者:
Kathleen N. Moore;Michael A. Gold;D. Mcmeekin;J. Walker;T. Rutledge;Kristin K. Zorn - 通讯作者:
Kristin K. Zorn
Updates of the Precision Medicine Program in Gynecologic Oncology
- DOI:
10.1016/j.ygyno.2016.08.249 - 发表时间:
2016-10-01 - 期刊:
- 影响因子:
- 作者:
Erin E. Brown;Michelle R. Rowland;Kathleen N. Moore;Camille C. Gunderson - 通讯作者:
Camille C. Gunderson
Weekly Paclitaxel for Recurrent Ovarian Cancer: Does Weekly Administration at Primary Diagnosis Impact Efficacy and Toxicity at Recurrence?
- DOI:
10.1016/j.ygyno.2016.08.266 - 发表时间:
2016-10-01 - 期刊:
- 影响因子:
- 作者:
Camille C. Gunderson;Alexa Papaila;Kai Ding;Amelia M. Jernigan;Haider Mahdi;Sarah Bedell;David S. Miller;Bradley J. Monk;Kathleen N. Moore - 通讯作者:
Kathleen N. Moore
Incorporating immune checkpoint inhibitors in epithelial ovarian cancer
在上皮性卵巢癌中纳入免疫检查点抑制剂
- DOI:
10.1016/j.ygyno.2024.12.011 - 发表时间:
2025-02-01 - 期刊:
- 影响因子:4.100
- 作者:
Giorgio Bogani;Kathleen N. Moore;Isabelle Ray-Coquard;Domenica Lorusso;Ursula A. Matulonis;Jonathan A. Ledermann;Antonio González-Martín;Jean-Emmanuel Kurtz;Eric Pujade-Lauraine;Giovanni Scambia;Giuseppe Caruso;Francesco Raspagliesi;Nicoletta Colombo;Bradley J. Monk - 通讯作者:
Bradley J. Monk
Safety and efficacy of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer
叶酸受体α(FRα)靶向抗体-药物偶联物(ADC)mirvetuximab soravtansine 与贝伐珠单抗联合用于铂耐药卵巢癌患者的安全性和有效性
- DOI:
10.1016/j.ygyno.2023.01.020 - 发表时间:
2023-03-01 - 期刊:
- 影响因子:4.100
- 作者:
Lucy Gilbert;Ana Oaknin;Ursula A. Matulonis;Gina M. Mantia-Smaldone;Peter C. Lim;Cesar M. Castro;Diane Provencher;Sanaz Memarzadeh;Michael Method;Jiuzhou Wang;Kathleen N. Moore;David M. O'Malley - 通讯作者:
David M. O'Malley
Kathleen N. Moore的其他文献
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{{ truncateString('Kathleen N. Moore', 18)}}的其他基金
A Lead Academic Participating Site in Oklahoma for the Design and Conduct of NCTN Clinical Trials
俄克拉荷马州设计和进行 NCTN 临床试验的主要学术参与中心
- 批准号:
10360544 - 财政年份:2019
- 资助金额:
$ 22.86万 - 项目类别:
A Lead Academic Participating Site in Oklahoma for the Design and Conduct of NCTN Clinical Trials
俄克拉荷马州设计和进行 NCTN 临床试验的主要学术参与中心
- 批准号:
9889077 - 财政年份:2019
- 资助金额:
$ 22.86万 - 项目类别:
A Lead Academic Participating Site in Oklahoma for the Design and Conduct of NCTN Clinical Trials
俄克拉荷马州设计和进行 NCTN 临床试验的主要学术参与中心
- 批准号:
10582583 - 财政年份:2019
- 资助金额:
$ 22.86万 - 项目类别:
A Lead Academic Participating Site in Oklahoma for the Design and Conduct of NCTN Clinical Trials
俄克拉荷马州设计和进行 NCTN 临床试验的主要学术参与中心
- 批准号:
10158024 - 财政年份:2019
- 资助金额:
$ 22.86万 - 项目类别:
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