Background:
The Hamilton Regional Cancer Centre (HRCC) has recently evolved to become one of the leading centres in the study of investigational new drugs (IND) in Canada. In addition to being the top accruer to IND studies to the National Institute of Canada Clinical Trials Group (NCIC-CTG) over the past two years, the centre has also been actively involved with industry-sponsored IND studies. These studies have involved the full-spectrum of initial phase I toxicity studies, as well as subsequent phase II and III efficacy studies. In a number of these studies, HRCC investigators have played a leading role in protocol development as well as serving as national principal investigators. The HRCC Clinical Trials Department has established expertise in carrying out such studies and the Systemic Therapy Programme has the facilities for supporting such studies.
McMaster has world-renowned expertise in the area of clinical trials methodology and design through the Department of Clinical Epidemiology and Biostatistics (CE&B). This will allow fellows in the programme the opportunity to become educated in IND trials theory and design through enrollment in courses offered by CE&B while at the same time getting a practical experience carrying out trials in the clinical setting at the HRCC. Translational research is becoming an increasingly important component of IND studies. The opportunities to participate in such research projects exist through the ongoing basic research studies at the HRCC and McMaster University.
Objectives:
To allow the fellow i) to gain expertise in the design and development of investigational new drug protocols, ii) to develop experience in taking protocols through the PRC and REB approval process, and iii) to gain experience in the clinical implementation and monitoring of patients entered onto IND protocols through working with clinical trials personnel and clinical investigators
Mentorship:
a staff medical oncologist with significant involvement and interest in IND studies will be designated as the supervisor of the fellow a supervisory committee will consist of the supervisor, the head of the HRCC residency programme and the head of Medical Oncology
Trial Design:
courses will be selected from those offered by CE & B to learn basics of trials methodology and design where appropriate, the fellow will interact with personnel from the Ontario Clinical Oncology Group (OCOG) to gain experience in clinical trials methodology, especially trial monitoring and data analysis
Protocol Development and the Approval Process:
- new protocols developed with supervision of PI
- critical review and assessment of protocols that have been written elsewhere
the fellow will be expected to appraise protocols that are submitted to the Protocol Review Committee and will attend and participate in the discussions at committee meetings allow ownership of protocols (as co-PI) and take responsibility for submission to PRC and REB (preparation of REB form, modification of consent, communication with clinical trials and HHSC laboratory programs re: resources) and presentation to PRC and REB.
IND Rounds:
will be expected to attend and present research proposals or preliminary results at monthly IND group meetings
HRCC Regional Oncology Rounds will be expected to present at these rounds at least once during the fellowship
Clinical Experience:
to follow patients on phase I/II and selected phase III studies establishment of IND clinics where these patients will be followed participate in recruitment of patients onto studies develop expertise in evaluation of toxicity, and measurement of response of patients on study.
Time Commitments:
- 40% of time will be devoted to clinical experience and direct patient interaction
- 40% of time will be spent on theory of trials design and evaluation and course work
- 20% of time will be allowed for development of specific research projects and research time
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
Basic Research Opportunities
fellows interested in including a translational research component to their fellowship have the opportunity to pursue this through on-going basic research studies at the Hamilton Regional Cancer Centre (e.g. action of metalloproteinases, biologyof bone metastases) and McMaster University (e.g. gene therapy)
RECRUITEMENT:
fellows will be recruited from the Medical Oncology Training Programme at the HRCC or from other medical oncology training programmes (Canadian and international) the existence of the IND fellowship programme will be communicated to Canadian and international medical oncology residency programmes advertising at national and international oncology meetings
FUNDING:
Potential funding sources include:
- seed funding from the HRCC/HRCC Foundation
- development of corporate/industry sponsorship
- international fellows bringing along their own funding
SALARY:
salary for the fellowship will be at the level of a clinical scholar (R5 level) as per McMaster University Authorship of Manuscripts and Travel the fellow will be expected write the abstract/ manuscript for any publications arising from protocols in which a major role was played the fellow will be funded for travel to one national and one international meeting to present the results of trials in which there was major involvement |
