Clinical Protocol and Data Management

临床方案和数据管理（CPDM） 摘要 临床协议和数据管理（CPDM）临床组件集中管理激活和 持续维护新墨西哥州大学癌症中心（UNMCC）的所有临床研究。的 人口与发展中心设在联合国赔偿委员会临床研究办公室内，负责处理临床和人口科学问题。 该中心的研究和全州范围内的新墨西哥州癌症护理联盟（NMCCA）临床试验 网络UNCC临床研究办公室和NMCCA的执行主任是Teresa Stewart，MS，CRCP，MT（ASCP）. UNCC临床研究办公室和NMCCA的整合提供了 通过新墨西哥州资助的增强型集中式基础设施，用于参与NCI申办的试验 少数民族/服务不足的国家癌症研究所社区肿瘤学研究项目（NCORP），研究者 发起的试验和行业赞助的试验。CPDM位于这一出色的基础设施内，由 其医疗主任，梅勒妮罗伊斯，医学博士，博士谁也是联合国儿童基金会多学科乳腺癌主任 癌症计划，和NCORP补助金（UG1CA189856）的主要研究者。在过去的四年里， 联合国儿童基金会临床研究办公室平均年度预算为290万美元，其中CPDM拨款为 六十六万七该方案每年平均管理整个联合国赔偿委员会的345项临床研究， NMCCA。在UNMCC和NMCCA网络开展临床研究的平均时间为14.1 2010年至2014年期间的平均增长时间为2010年至2014年的10周（每年波动很小），比2009年快了46%。从 从2010年1月至2014年6月，联合国赔偿委员会社区方案管理机制为3 264名应计病人参加临床研究提供了支助; 1628例患者参与干预性研究，1636例患者参与非干预性研究（根据数据表 4个标准）。从2010年1月至2014年6月30日，UNCC CPDM招募了1226名受试者接受治疗， 干预试验（根据数据表3标准），这代表平均治疗试验入组率为16.6%， 在四年半期间，新诊断和/或接受联合国赔偿委员会治疗的病人中，联合国赔偿委员会应计病人数 CPDM管理的所有临床研究的数量为：483（2014年前六个月）; 617（2013年），727（2012年）， 772（2011）和665（2010）。根据2013年的数据：1）67.9%的累积患者为女性， 新墨西哥州妇女的癌症发病率仅为49.3%，2）40.6%的患者为西班牙裔， 新墨西哥州的西班牙裔癌症发病率仅为29.2%，3）8.5%的患者应计费用是 而在新墨西哥州，美洲印第安人的癌症发病率为5.0%。因此， 继续招收妇女和少数民族的速度超过了新墨西哥州的癌症发病率，其中 特定人群，表明对国家服务不足人群的承诺， 联合国气候变化委员会科学任务。

CLINICAL PROTOCOL & DATA MANAGEMENT (CPDM) ABSTRACT The Clinical Protocol and Data Management (CPDM) clinical component centrally manages the activation and ongoing maintenance of all clinical research for the University of New Mexico Cancer Center (UNMCC). The CPDM is housed within the UNMCC Clinical Research Office and handles both clinical and population sciences research at the Center and across the statewide New Mexico Cancer Care Alliance (NMCCA) clinical trial network. The Executive Director of both the UNMCC Clinical Research Office and the NMCCA is Teresa Stewart, MS, CRCP, MT (ASCP). The integration of the UNMCC Clinical Research Office and NMCCA provides an enhanced centralized infrastructure for participation in NCI-sponsored trials funded through the New Mexico Minority/Underserved National Cancer Institute Community Oncology Research Program (NCORP), investigator initiated trials, and industry sponsored trials. The CPDM lies within this outstanding infrastructure and is led by its Medical Director, Melanie Royce, MD, PhD who is also the Director of the UNMCC Multidisciplinary Breast Cancer Program, and the Principal Investigator of the NCORP grant (UG1CA189856). During the past four years, the UNMCC Clinical Research Office average annual budget was $2.9 million of which the CPDM allocation was $667,000. The CPDM administers an annual average of 345 clinical research studies across UNMCC and NMCCA. The average time to open a clinical research study at the UNMCC and the NMCCA network was 14.1 weeks in the period 2010-2014 (with little fluctuation across each year) and was 46% faster than in 2009. From January 2010 to June 2014, the UNMCC CPDM supported 3264 patient accruals to clinical research studies; 1628 patients accrued to interventional studies and 1636 patients to non-interventional studies (per Data Table 4 criteria). From January 2010 – June 30, 2014, UNMCC CPDM enrolled 1226 subjects to therapeutic intervention trials (per Data Table 3 criteria), this represents an average therapeutic trial enrollment of 16.6% of newly diagnosed and/or treated UNMCC patients over the four and a half year period. UNMCC patient accrual numbers to all clinical research managed by CPDM were: 483 (first six months of 2014); 617 (2013), 727 (2012), 772 (2011) and 665 (2010). Based on data from 2013: 1) 67.9% of the accrued patients were female while the cancer incidence for women in New Mexico is only 49.3%, 2) 40.6% of the patients accruals were Hispanic while the cancer incidence for Hispanics in New Mexico is just 29.2%, and 3) 8.5% of the patient accruals were American Indian while the cancer incidence in New Mexico among American Indians is 5.0%. Thus, the UNMCC continues to enroll women and minorities at rates that exceed the New Mexico cancer incidence among these specific populations, demonstrating commitment to the State's underserved populations and congruence with the UNMCC scientific missions.