CLINICAL TRIALS AND MENTORING IN ONCOLOGY RESEARCH

该K24的目标是允许主要研究者（PI）进行医学肿瘤学的临床研究并指导新的研究者。 PI的当前计划确定了泌尿生殖系统恶性肿瘤患者的新治疗方案，特别是睾丸癌和肾细胞癌（RCC）。睾丸生殖细胞瘤（GCT）被认为是可治愈癌症的模型，70%的晚期GCT患者通过顺铂联合化疗治愈。 然而，30%的耐药GCT患者需要更有效的治疗。 研究工作的重点是在预测为耐药的患者的一线治疗中纳入剂量强化治疗，剂量强化的新方法，以及鉴定具有抗肿瘤作用的新药，并将其纳入联合治疗。 相反，RCC代表了对化疗最耐药的恶性肿瘤。生物制剂，即干扰素-α，显示出低程度的活性。 针对RCC的努力针对增强干扰素活性的治疗方案的研究和用于抗肿瘤活性的新型药剂的研究。 在过去10年中，PI进行了23项I、II和III期前瞻性机构审查委员会批准的临床试验。 对于这两种肿瘤，已经建立了临床数据库，以确定预后因素和指导治疗。 作为一名临床研究者，参与转化研究是我研究工作的基础。作为医学系临床试验副主席，PI负责监督临床试验办公室，该办公室由50名研究助理组成，负责该部门所有临床试验的流程和数据管理。 将这一职位的影响纳入GCT和RCC的积极临床试验计划中，为医学肿瘤学研究员在临床试验方法学教学中提供了一个独特的学习机会。 在我们的中心获得一批受训的研究员使这成为可能。 临床试验方法学的教育是通过直接监督和教学在一对一的基础上在临床上，通过辅导，并在会议。 强调了临床试验进行的技能，如编写方案，获得知情同意，反应和毒性评估以及数据分析要求。 PI在第二年和第三年的培训期间指导了10名医学肿瘤学研究员;六名活跃在学术肿瘤学和/或临床研究者职业生涯中。 其中一名最近加入了医学、外科和儿童中心泌尿生殖科的工作人员。 临床试验的指导超出了奖学金，以初级教员。

The goal of this K24 is to allow the principal investigator (PI) to pursue clinical research in medical oncology and mentor new investigators. The PI's current program identifies new treatment programs for patients with genito-urinary malignancies, specifically testicular cancer and renal cell carcinoma (RCC). Germ cell tumor (GCT) of the testis is considered a model for the curable cancer, with 70 percent of patients with advanced GCT cured by cisplatin-combination chemotherapy. However, the 30 percent of patients with resistant GCT require more effective therapy. Research efforts focus on inclusion of dose-intensive therapy in first-line treatment for patients predicted as resistant, novel means of dose-intensification, and the identification of new agents with antitumor effect which are incorporated into combination therapy. In contrast, RCC represents the most resistant malignancy to chemotherapy. Biological agents, i.e. interferon-alpha, show a low degree of activity. Efforts against RCC are directed at the study of treatment programs to augment the activity of interferon and the study of novel agents for antitumor activity. During the past 10 years, the PI has conducted 23 phase I,II and III prospective Instituitional Reveiw Board-approved clinical trials. For both tumors, a clinical database has been established to identify prognostic factors and direct therapy. Participation in translational research is fundamental for my research effort as a clinical investigator. In the PI's position as Associate Chairman, Clinical Trials, Department of Medicine, the PI oversees the Clinical Trials Office, which is comprised of 50 research assistants and is responsible for process and data management of all clinical trials in the Department. Bringing the impact of this position to bear in an active clinical trial program in GCT and RCC creates a unique opportunity as a comprehensive learning experience for medical oncology fellows in teaching clinical trial methodology. Access to a cadre of fellows-in-training at our center makes this possible. Education in clinical trial methodology is given by direct supervision and teaching in a one-to-one basis in the clinic, through tutoring, and in conference. Skills of clinical trial conduct such as writing protocols, obtaining informed consent, response and toxicity assessment, and analysis of data requires are emphasized. The PI has mentored 10 medical oncology fellows-in training during their second and third year of training; six are active in academic oncology and/or clinical investigator careers. One recently joined staff at MSKCC in the Genito-urinary Section. Mentoring of clinical trials is extended beyond fellowship to junior faculty members.