Juravinski Cancer Centre (JCC) Foundation Mark Levine Fellowship Programme Background This Fellowship has been established by the Juravinski Cancer Centre Foundation in recognition of Dr. Mark Levine, the Chief Executive Officer of the Juravinski Cancer Centre - JCC (formerly Hamilton Regional Cancer Centre – HRCC), from 1991 to 1999. Given Dr. Levine’s passion for clinical research, this fellowship will provide research training in the methodology of clinical research, particularly but not exclusively clinical trials. The goal is to train the researchers of tomorrow. Environment: The JCC provides an excellent training ground. Several JCC researchers are internationally recognized trialists and health services researchers. They lead research programs funded by external peer-review grants from the Canadian Institutes for Health Research (CIHR), National Cancer Institute (NCIC) and Ontario Ministry of Health and Long Term Care (MOHLTC). The JCC has been a leading recruiter to clinical trials at all phases of development, both with co-operative groups such as the NCIC - Clinical Trials Group, the Ontario Clinical Oncology Group (OCOG), as well as with industry partners. These studies have involved the full-spectrum of initial phase I toxicity studies, as well as subsequent phase II and III efficacy studies, and studies of supportive care. In many of these studies, JCC investigators have played a leading role in protocol development as well as serving as national principal investigators. The JCC Clinical Trials Department has established expertise in carrying out such studies and the Systemic Therapy, Radiation Therapy, and Surgical Oncology Programs have the facilities and expertise for supporting such studies enhanced by having well established multi-disciplinary disease site groups. Adjacent to the JCC is the Henderson Research Centre which houses the Coordinating & Methods Centre of OCOG. Here the research fellow will have the opportunity to gain hands on experience in the design, execution and analysis of multicentre clinical trials. The Supportive Cancer Care Research Unit (SCCRU) is located in the JCC. This research unit conducts health services research on cancer care including quality of care, decision making, and improving access to cancer care. The SCCRU has held continuous peer review funding for over 10 years from the Ontario MOHLTC. McMaster has world-renowned expertise in the area of clinical trials methodology through the Department of Clinical Epidemiology and Biostatistics (CE&B). This will allow fellows in the program the opportunity to become educated in clinical trials design, execution, analysis, and administration through enrollment in courses offered by CE&B while at the same time getting a Revised: 03/07/16 1 practical experience carrying out trials through OCOG and in the clinical setting at the JCC. There is also the opportunity to pursue an interest in economic analysis of trials and translating research findings from trials into practice and policy through collaborations within CE&B. Translational research is becoming an increasingly important component of clinical trials, especially in Investigational New Drug (IND) studies. The opportunities to participate in such research projects exist through the ongoing basic research studies at the JCC and McMaster University. Eligibility The fellowship will support the training of physicians (MD) who wish to pursue a career in clinical cancer research and will not be used for further PhD training. These individuals should be in the final year of a Royal College certified program in their cancer-related specialty, i.e. medical oncology, radiation oncology, surgical oncology or hematologic oncology when applying. Candidates must be Canadian citizens or landed immigrants qualified to practice in Ontario. The candidate should clearly have the desire to pursue a career in academic medicine with the goal of becoming an independent clinical investigator. Objective The primary objective of the 2-year program is to provide in-depth training in the principles and methods of clinical research; in the areas of translational, clinical trials, or health services research. Research Training The research training will be in one of three streams: 1) Clinical Trials, 2) Health Services Research, or 3) Translational Research. The fellow pursuing either clinical trials or health services research will be expected to enroll in the Health Research Methodology (HRM) Program in the Faculty of Health Sciences, McMaster University. An appropriate supervisor related to the selected area will be appointed to mentor the individual during the fellowship. (*NOTE – Applications to the HRM Program are due in the Fall prior to starting this Fellowship) The clinical trials and health services research will allow the individual: i) to gain expertise in the design and development of clinical trial and/or health services research protocols, ii) to develop experience in taking protocols through the Protocol Review Committee (PRC) and Research Ethics Board (REB) approval process, iii) to become familiar with writing grants and submitting them, and iv) to gain experience in the clinical implementation and monitoring of patients entered onto trial protocols through working with the Department of Clinical Trials/Supportive Cancer Care Research Unit personnel and clinical investigators. The fellows will receive hands on experience in the conduct of large multicentre trials in OCOG including trial design, data management and analysis. Revised: 03/07/16 2 Through working in the SCCRU there is the opportunity to complement the research experience by learning about health economics and knowledge translation. Fellows interested in the area of translational research will have the opportunity to pursue this through on-going basic research studies at the Juravinski Cancer Centre and McMaster University. The aim however, is that they bridge the lab and clinic. Examples include novel biomarkers, pharmacology of targeted agents and imaging. They will have a supervisor who will mentor the individual in the development of a clinically relevant translational research project to ensure that he/she succeeds. Mentorship A staff oncologist/research scientist with significant involvement and experience in the chosen area of interest will be designated as the supervisor of the Fellow. A supervisory committee will consist of at least the supervisor and the head of the appropriate JCC residency program or Head of Basic Science. Clinical Experience Horizontal clinics will be established to allow the Fellow to follow patients on selected studies. The Fellow will participate in recruitment of patients onto studies and will develop expertise in evaluation of toxicity, and/or measurement of response endpoints relative to the studies being followed. Time Commitments Approximately 20% of the Fellow’s time will be devoted to clinical experience and direct patient interaction. Approximately 40% of time will be spent on theory of trials design and evaluation and course work. The remaining 40% of time will be allowed for development and conduct of specific research projects. It is expected that a two-year commitment will be made by the Fellow to allow completion of the fellowship objectives. The Fellow will be expected to take part in after hours and weekend coverage which will be negotiated at the start of the Fellowship. Salary Remuneration will be based on the individual’s level of post-graduate training and will be competitive with that of Clinical Scholars in the FHS McMaster. Funding will also cover tuition fees (if required) for the HRM Program. Revised: 03/07/16 3 Report at the End of the Fellowship A report will be submitted at the end of the fellowship period to the Fellowship Committee. It should contain the evaluation by the Fellow’s supervisor, a description of the project(s) activities undertaken, and presentations, abstracts or publications arising from such projects. Revised: 03/07/16 4 Application The application should be sent to: Juravinski Cancer Centre Foundation Grants & Distribution Committee c/o 699 Concession Street, Rm 1-106 Hamilton, ON L8V 5C2 It should contain: an up-to-date curriculum vitae letters from two referees involved in the candidate’s training, one of whom should be the program director a 1-2 page description of the proposed clinical and/or research work to be undertaken during the fellowship period a description of the relevance of the proposed training to the future career of the candidate information as to whether the candidate has been offered a position in an Ontario institution with a cancer care program. Deadline The deadline for receipt of applications is July 11, 2008. Candidates will be notified of the decision about their applications by July 25, 2008. The fellowship will be tenable for two years beginning September 1st 2008. Revised: 03/07/16 5