CLINICAL TRIALS AND MENTORING IN ONCOLOGY RESEARCH

本K24的目标是允许首席研究者（PI）从事医学肿瘤学的临床研究并指导新的研究者。PI目前的项目为生殖-泌尿系统恶性肿瘤患者确定了新的治疗方案，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典范，70%的晚期生殖细胞瘤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。研究的重点是在一线治疗中纳入预测为耐药的患者的剂量强化治疗，新的剂量强化手段，以及确定新的抗肿瘤药物，并将其纳入联合治疗。相比之下，RCC是对化疗最有抵抗力的恶性肿瘤。生物制剂，如干扰素- α，表现出低程度的活性。针对RCC的努力是针对治疗方案的研究，以增强干扰素的活性和抗肿瘤活性的新药物的研究。在过去的10年里，PI已经进行了23项经机构审查委员会批准的I、II和III期前瞻性临床试验。对于这两种肿瘤，已经建立了临床数据库来确定预后因素和直接治疗。作为一名临床研究者，参与转化研究是我研究工作的基础。在PI担任医学部临床试验副主席的职位上，PI监督临床试验办公室，该办公室由50名研究助理组成，负责该系所有临床试验的流程和数据管理。将这一职位的影响运用到GCT和RCC的积极临床试验项目中，为医学肿瘤学研究员在临床试验方法教学方面提供了一个独特的全面学习机会。我们中心的培训人员使这成为可能。临床试验方法学的教育是通过直接监督和一对一的临床教学，通过辅导和会议进行。强调临床试验进行的技能，如撰写方案、获得知情同意、反应和毒性评估以及数据分析要求。PI在培训的第二年和第三年期间指导了10名医学肿瘤学研究员；其中6人活跃于学术肿瘤学和/或临床研究者的职业生涯。其中一位最近加入了MSKCC的泌尿生殖科。对临床试验的指导从研究员扩展到初级教员。

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.