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Clinical Research Centre of the Research Institute of the McGill University Health Centre |
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Center Overview
The Clinical Research Centre (CRC) was established by Dr. Phil Gold in 1995 as an infrastructure of the Montreal General Hospital Research Institute to promote clinical trials research within the health care establishment. For over more than five years, the CRC is pursuing its mission to provide educational programs in clinical research, to facilitate the conduct of clinical trials, and to promote the clinical investigator’s portfolio to industry, in order to provide innovative treatments for patients across all sites of the McGill University Health Centre (MUHC) including The Montreal General Hospital, Royal Victoria Hospital, The Montreal Children’s Hospital, The Montreal Chest Institute and The Montreal Neurological Hospital. With over 400 clinical investigators, The Research Institute of the McGill University Health Centre has one of Canada's largest clinical research centres, providing both state-of-the-art health care to its patients and innovative biomedical and clinical research. The McGill University Health Centre is fortunate to have a most productive Research Institute. All of the partner hospitals and the Institute foster close collaboration between basic and clinical scientists, allowing clinical investigators to produce novel research data with major commercial potential and to attract industrial sponsorship in all four phases of clinical trials and other forms of technology transfer. The RI MUHC clinical investigators have a solid reputation and the MUHC Clinical Research Centre provides an infrastructure which assures services to its investigators and a point of contact for industrial sponsors seeking approval for pharmaceutical agents and medical Devices. The Centre has become a major Canadian clearinghouse for interaction between academia and industry and for providing pharma with advice.
In May 2000, the CRC expanded its infrastructure to include the Office of Clinical Contracts (OCC) of the Research Institute of the MUHC. The mandate of the OCC is to ensure harmonization and standardization of policies and procedures governing health research involving human subjects at the MUHC. Among the OCC’s objectives for 2000-2001 was the development of Policies and Procedures for Ethics, Legal and Financial Review of Industry-Sponsored Clinical Contracts at the MUHC. This goal was achieved by the OCC in a joint endeavor with the Office of Research Ethics (REO). Another milestone established jointly by the OCC and REO during 2000-2001 was the development of a Regulatory Framework in Health Research at the MUHC. This regulatory framework fulfills the requirement set forth by Quebec’s Ministry of Health to ensure the protection of human subjects participating in clinical research and to ensure scientific integrity of research leading to the marketing of innovative drugs and medical devices.
Together, the Clinical Research Centre and the Office of Clinical Contracts play complementary roles in teaching, promoting, and facilitating the conduct of clinical research, as well as ensuring ethics and scientific integrity of clinical trials research at the McGill University Health Centre. The Clinical Research Centre has recently changed its name to the Office of Clinical Research for appropriate designation.
Clinical Research Experience
MUHC hospitals have a 30 year experience in clinical trials in virtually all therapeutic areas which include the following:
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Investigator Experience
Click here for a contact list of Clinical Investigators.
Staff Expertise
- Academic expertise and world-class medical specialists with international reputation in the medical and pharmaceutical industry.
- Clinical investigators can execute pre-clinical studies, Phase I, II, III and IV trials.
- A superb Division of Clinical Epidemiology can provide services in trials design, data analysis, health care economics and pharmaco-economics.
- All Clinical Research Coordinators have been trained by ACRP.
- Extensive network of researchers in hospitals, community and research institutes and network of representatives of governments, industry and health care services.
Patient Demographics
- Population: over 3.3 million in greater Montreal, a cosmopolitan area and city.
- Number of out-patient visits: about 300,000 per year
- Number of admissions: 45,322
- Beds utilized: 1500 average total beds staffed
- Operating Rooms (including day surgery): 21
- Number of OR patients: 19,576
- Age and gender distribution: adults of all ages and both genders
Other Information
Services and resources provided by the Clinical Research Centre of the RIMUHC
Single Point of Entry for Clinical Trials Proposals
It is essential that the MUHC offers a single point of entry where sponsors may forward their clinical trials proposals, and of which both Sponsors and CROs should be aware. The critical issue is that the Entry Point be user-friendly, have availability of personnel whenever a problem arises, attempt to preempt and/or to intercept problems very early and to provide an ease of tracking of studies.
Staff Expertise Contact list of Clinical Investigators
Academic expertise and world-class medical specialists with international reputation in the medical and pharmaceutical industry. Clinical investigators can execute pre-clinical studies, Phase I, II, III and IV trials. A superb Division of Clinical Epidemiology can provide services in trials design, data analysis, health care economics and pharmaco-economics. All Clinical Research Coordinators have been trained by the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA). There is an extensive network of researchers in hospitals, community and research institutes and network of representatives of governments, industry and health care services.
Establishment of Standard Operating Procedures and Policies for the Conduct of Clinical Trials
Although pharmaceutical firms (Sponsors) and Contract Research Organizations (CROs) that have approached the MUHC for clinical trials studies have their own specific Standard Operating Procedures (SOPs) in place, it demonstrates "good style" on the part of the institution to have its own procedures in hand to ensure GCP in compliance with FDA, HPB and ICH guidelines. This activity was "out-sourced" very early in the development of the CRC and its SOPs were constructed in consultation with a wide variety of the members of the clinical investigative staff.
The SOPs include the following procedures: Preparation and submission of regulatory documents to sponsors; Submission of clinical trials research applications to the REB; Conduct of clinical trials; Role and responsibilities of the sponsor in the conduct of clinical trials; Responsibilities of the clinical investigator during the conduct of study-related visits with the sponsor; Management of the clinical investigator - REB interactive process; Clinical trials files management; Serious adverse event reporting; Study blind code management; Clinical trial completion/termination; and Handling and dispensing of study drugs.
In addition to SOPs for the conduct of clinical trials, institutional policies have been ratified in regards to: Intent in the conduct of clinical trials; Evaluation of the clinical trial proposal; and Evaluation of the Clinical Trial Letter of Agreement and Letter of Indemnification between the Sponsor and Clinical Investigator/Institution. The policies regarding the contractual clauses in the letters of agreement (contracts) aim to ensure publication rights to the investigator allowing for dissemination of patient safety information in the public domain, as well as rights to potential inventions and discoveries in order to protect the clinical investigators' intellectual property.
Scientific Review of Clinical Trial Proposals
When a clinical trial proposal, usually in the form of a synopsis or detailed protocol, is first presented to the Centre, it is reviewed briefly by one of its staff members (Dr. Phil Gold) to identify potential clinical investigators within the various institutions who would be best involved in the trial proposed. The protocol is then sent on to these investigators and a request is made for a scientific review both internally and, wherever possible, by external referees as well. Emphasis is placed on a wide variety of parameters in such a review that deal with: the rationale for the study, the study design, the method of patient selection and randomization, the timeline for initiation and completion of the study, endpoint definitions, the methods of analysis, the manner in which reporting of the results will be done, and, most importantly, the potential benefit to the patients to be enrolled in the study.
Diligent protocol submission and review by MUHC REBs, with average 3-week turn-around period, as well as diligent contractual review by the RIMUHC
Pre-REB Screening of Clinical Trial Proposals. Once the scientific validity of the study has been established and that one or more clinical investigators have agreed to conduct the study, the Protocol is reviewed by a OCC staff member who is knowledgeable in REB needs and procedures. Indeed, a "check sheet" for both the Principal Investigators and industrial partners is effectively in place so that the Protocol will not be submitted to Ethics Review until the various requirements have been fulfilled. In parallel to pre-REB screening, the CRC will also request a draft of the clinical letter of agreement from the Sponsor in order to suggest changes in the contract, if required, to ensure adequate dissemination of patient safety information, publication rights and protection of intellectual properties. Moreover, the CRC will offer assistance to the investigator to ensure that the study budget proposed by the Sponsor, or submitted by the Investigator, will cover all study expenditures and contingencies.
Research Ethics Board (REB) Approval of Clinical Trial Proposals. It is critical that the REB have appropriate composition with representation from different groups, including medical scientists, basic scientists, ethicists, lawyers, representatives of the lay community, clergy and etc. Specific expertise is coopted in special circumstances is necessary. No member of the REB is paid and all of the work is done pro bono. It is critical that there be efficient and rapid turn-around time in order to fulfill the requirements of both industry and, indeed, academia. This process is much improved by the Pre-REB Review. The guidelines under which REBs function are those that have been established by the Tri-Council Report and the International Conference on Harmonization (ICH).
Transparent Costing
Support for transparent itemized costing and budget preparation for investigators and sponsors, as well as single-site financial management by the administration of the MUHC Research Institute;
A rather thick manual itemizing the cost of virtually every conceivable test available at the hospital, from the simplest determination of electrolytes to the most costly imaging, have been put in place in order to assist both the investigator and the company in terms of budget development. Each required test becomes a line item and there can be no question as to why costs have accrued. In this context, one staff member (in the case of the MGH Campus, Dr. Joseph Shuster, Associate Director of the RIMUHC at The MGH site) scrutinize each budget to assure standardization for both the Principal Investigator and the company involved. In addition, there is a clearly-defined overhead cost established at the beginning of the study. At the moment, the fixing of this cost for all of the hospitals within the MUHC is under active consideration. The target for overhead charge is 30%, which is added to the total cost of the study. An additional charge of one-thousand-two-hundred-and-fifty dollars ($2150.00) is made to the company for IRB review (whether the study is approved or not), including protocol review by Pharmacy to assess investigational drug management costs. Such transparent costing has been a major step forward in our relationship with industry in every fashion.
Training Programs
Training of clinical research investigators via a Clinical Investigator Diploma course and Clinical Research Coordinators via the Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Professionals (SOCRA), to comply with FDA-HPB-ICH GCP-GLP guidelines (click here to view additional Training Programs)
Execution of pre-clinical studies, Phase I, II, III and IV trials (Phase I studies done with patients, not with healthy volunteers, in therapeutic areas such as Oncology and HIV/AIDS)
Central Pharmacy. A network of MUHC Central Pharmacies dedicated to the dispensing of investigational drugs.
Specialized Pre-Clinical, Clinical Trial Design and Laboratory Services
Clinical (metabolism, biochemistry, endocrinology, hematology, microbiology, pathology, etc.) and Diagnostic Laboratories which offer a wide spectrum of laboratory analyses including pharmacokinetics, chirality and phenotypic drug metabolism. In addition to nurses and coordinators, other services have been put in place that may be provided as necessary by other basic and clinical scientists in house. Amongst these, for example, are the services provided by the Division of Clinical Epidemiology in terms of Protocol Design and Health Economics/Pharmacoeconomics, if requested by a company. Moreover, special laboratory tests may be done upon request and, indeed, tests have been developed for certain companies in the process of protocol design. In addition, the MUHC offers a unique expertise in the field of Pharmacogenomics, pioneered by members of our Genome Centre, such as Dr. Tom Hudson, yielding novel clinical trial designs integrating the genetic diversity affecting drug metabolism in patient populations. As already indicated above, with the wide variety of basic laboratory interests in place, our research laboratories can provide a wide spectrum of pre-clinical studies, if required and of mutual interest to a company and one or more of our scientists. As concerns routine chemistry, the costs for such tests are itemized and performed on site, as required.
Provision of Staffing Needs
The Clinical Research Centre has undertaken to provide the staffing that any Principal Investigator may require for any new study. A list of nurses has been compiled who are "on availability" as well as of Clinical Research Coordinators. There are two ways in which Clinical Research Coordinators are employed. On one of our sites such personnel are paid on an annual stipend and go from project to project as required. On another site, the payment (salary) to coordinators are a line-item of the budget. In neither case is there "downtime" for these members of staff that there is always sufficient numbers of trials in progress to keep everyone quite busy. We have not yet decided as to whether all of the hospital should go to a single policy at the present time. Indeed, it is more a matter of philosophy than practicality.
Investigator-Initiated Research
Although the Clinical Research Centre was established to do what its name implies, all areas within the academic institution must strive toward the development of new intellectual endeavors. Hence, the initiation of a clinical trials contract should really be considered as a "thin edge of the wedge" in introducing industry to our fundamental research and intellectual expertise. Indeed, a menu has been developed of this type of information and this will comprise a major aspect of the report being delivered to FRSQ. Again, within the development of the new research axes, there are clear menus of expertise for our industrial partners to see. A number of studies have already been initiated in this fashion. Some have evolved by one-on-one discussions between the investigator and the company while others have been initiated by the company learning of the expertise in place and approaching the investigator for work at a more fundamental level. In fact, true scientific collaboration is the ultimate form of university/industry interaction.
Training Programs
The Clinical Research Centre of RIMUHC has implemented several training programs in clinical research, targeting clinical investigators as well as their research teams (clinical research nurses, clinical research coordinators). The programs aim at ensuring Good Clinical Practice (GCP) in the conduct of industry-sponsored and investigator-initiated clinical research at the MUHC in compliance with all applicable guidelines, laws and regulations.
Clinician Investigator Program of the Royal College of Physicians and Surgeons of Canada. Established by Dr. Phil Gold
in 1995, this program assists the career development of the clinician-investigator in Canada by providing a formalized
post-graduate training program that fulfills the existing clinical specialty /subspecialty training requirements of the Royal
College. It provides a minimum of two years of structured rigorous research training. For further information on the CIP, please see http://www.med.mcgill.ca/postgrad/programs/cip.htm.
Graduate Diploma in Clinical Research. Established at the MUHC in 1999 by Drs. Phil Gold, Gerald Price and Irv Wainer,
it constitutes a new degree program from the Division of Experimental Medicine at McGill University. The program introduces
participants to the intricacies of a clinical research protocol initiation through data analysis, with emphasis on clinical
trials, phases I and II. This is a 30-credit course, 24 of which includes specific new courses. The core element of the
diploma is the Practicum in Clinical Research (18 credits). It is open to medical professionals (both in academia and
industry) having an undergraduate degree in the medical/allied sciences. For further information of the Diploma in Clinical
Research, please see http://www.medcor.mcgill.ca.
Training by the Association of Clinical Research Professionals (ACRP). The Clinical Research Centre has coordinated
Preparatory Courses and Certification Exams for Clinical Research Coordinators (CRCs) and Clinical Research Associates (CRAs)
by the Association of Clinical Research Professionals (ACRP, Washington D.C.). Over 100 candidates from the RIMUHC have
received the ACRP training. For further information on the ACRP, please see http://www.acrpnet.org.
Training by the Society of Clinical Research Associates (SoCRA). For further information on SOCRA, please see http://www.SoCRA.org.
Industry-Sponsored Training Programs. The Clinical Research Centre regularly disseminates educational opportunities in clinical research to the MUHC scientific community, including industry-sponsored training programs that are designed with the goal of improving the standard of clinical research in general.
Public Relations and Industry Awareness
Parexel International
The Clinical Research Centre of the Research Institute of the McGill University Health Centre has signed a co-marketing
agreement with PAREXEL International, one of the major Contract Research Organizations in the world (http://www.parexel.com). This will bring a great many new clinical trials,
at all Phases, to our attention for at first refusal. Hopefully, we will not have to refuse many. Moreover, we shall likely
become the international laboratory site for PAREXEL International in performing studies in Pharmacogenomics and
Pharmacophenotypy.
Contact Information
For more information, please contact:
Dr. Phil Gold
Executive Director
Clinical Research Centre of the Research Institute of the McGill University Health Centre
1650 Cedar Ave, Suite D13-173
Montreal, Quebec H3G 1A4 Canada
Phone: 514-934-1934 local 43061
Fax: 514-934-8338
E-mail:
If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.
