By Nicholas Herten-Greaven
Canada’s Clinical Research industry is healthy and appears to be growing faster than ever. Hospitals, medical research centres and pharmaceutical firms have been increasing their research activities, and in particular their use of clinical trials. This in turn has created increased opportunities for qualified professionals, including clinical research associates, coordinators, managers and investigators.
Ontario is home to a large number of public research facilities including hospitals and pharmaceutical companies that conduct clinical trials. Hospitals include the University of Toronto, Princess Margaret Hospital (Part of the University Health Network), the Hospital for Sick Children, the Ottawa Heart Institute and the London Health Sciences Centre. Meanwhile pharmaceutical companies in Ontario include Astrazeneca, Bayer, Biovail Dimethaid and Glaxosmithkline; as well US pharmaceutical companies will often have sites in Ontario. More than 800 life sciences companies operate in Ontario, employing 40,000 people and generating more than $10.7 billion in annual revenues.
The appeal of Canada as a centre for clinical trials is due to several factors, including government support for Research and Development (R&D), the demographic and ethnic diversity of our population, an excellent healthcare system and Canada’s unique population based health data. This is helping to boost expansion of clinical research facilities throughout the country. For example, the Ontario Institute of Cancer Research invested $11 million in 2008 to build a network of 30 clinical trial sites throughout the province.
One important issue for clinical research development in Canada is being able to find qualified professionals who can develop and manage clinical trials. The people now entering this field are Canadian and internationally educated health professionals such as internationally trained physicians, surgeons, nurses, research scientists, investigators and academics; university graduates with Masters, Doctorates or Bachelor degrees. They view clinical research as an area that will allow them to utilize their experience and skills in the healthcare field.
The training and education of clinical trials researchers seems however to be somewhat unstructured in Canada; in the UK for example, training is relatively well organized and structured, for example:
John Moores University in Liverpool, UK is a university dedicated exclusively to research, offering entry level programs that operate out of many university based research centres and institutes. We have no equivalent in Canada. In July 2006, 56 students graduated from LJMU in different clinical research specialties.
Ontario’s Training Colleges (Career Colleges) offer the only entry level programs in Canada available for those wishing to follow careers in clinical research. Humber College of Technology and Advanced Learning is the largest and one of four Ontario colleges offering a diploma in clinical research; the other three are the Michener Institute for Applied Health Sciences, the Academy of Applied Pharmaceutical Sciences and Oxford College of Arts, Business and Technology.
The Oxford College Clinical Research program focuses on delivering a set of well planned, comprehensive, relevant and up-to-date courses. Clinical Research programs often show up (on-line and elsewhere) as a bunch of subjects tossed together like a garden salad that do little more than to offer an arbitrary tasting of the topics du jour to the student, … programs that are often dependent on whatever happens to be available, or of some particular interest at the time. The Oxford program is unique as it follows a regularly updated sequence, building on solid fundamentals so as to provide the future coordinator, manager or trialist with a good understanding of clinical research, including a set of hard and soft skills. Trainees often discover that the Oxford courses have surprisingly little to do with a background in clinical medicine or nursing care and that the materials in fact cover completely new areas.
At an advanced level, Cranfied University in England, a wholly postgraduate research university offers a M.Sc. in clinical research as well as a Post Graduate Diploma and Certificate in Research. Cranfield has grown to become the largest centre in Europe for applied research, development and design. In Ontario, McMaster University appears to be the only Canadian organization offering a short yet structured, more advanced program in clinical research. A Certified Clinical Research Associate (CCRA) program is available at ‘Mac’ under Continuing Education; five courses are delivered and five years of clinical research experience are required in order to apply.
There are seventeen Faculties of Medicine in Canada. With the exception of McMaster, the five remaining Ontario medical schools at the universities of Toronto, Ottawa, Western Ontario, Queens and Northern Ontario do not appear to have structured basic education or training programs that focus either exclusively or comprehensively on clinical research. Faculties of Medicine are mandated and concerned with the medical education and training of highly screened students to produce physicians and surgeons. Other than as the optional MD Research Thesis offered in some schools, clinical research does not appear to be taught as a program, nor does it appear to be a credit or subject requirement for obtaining a medical degree at any medical school, or for obtaining a nursing degree at any Canadian university or school of nursing. Typically medical schools (McGill, Toronto) may offer workshops and short courses in clinical research for their medical trainees, residents and hospital nursing staff, although other candidates may apply.
In Canada we have no certified CRA/CRC programs and there is no CRA/CRC certifying or higher authority in Canada to certify either clinical research programs or diplomas. Certified CRA/CRC diplomas in Canada (CCRA, CCRC) are diplomas that are called certified by the institution that grants them, at its option. Certifying organizations do exist in the U.S., which will certify a candidate by examination, so that CRA/CRC applicants may become certified (but not programs) after applicants have accumulated varying lengths of experience.
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Over the last three years the UK has done some excellent work by surveying health professionals involved in clinical research. One recent survey covered some 700,000 UK nurses, midwives and allied health professionals and has started laying much of the groundwork via opinions and feedback that is aimed at improving the recognition, power and status of nurses in the area of clinical research. A second survey is working on doing the same for the medical profession. The UK initiatives are suggesting frameworks for this activity which is currently learnt largely “on the job” often as an aside involving junior staff. The UK initiatives are making the case for a more formalized structure, approved training pathways, incentives and in particular, recognition and merit.
To summarize, training for entry level clinical research is somewhat loosely structured in Canada; it is a loosely defined and loosely regulated activity for which only minimal formal training is available; and there are no Regulatory Colleges. At the higher levels, clinical research courses and training tend to be available as adjuncts or extramural activities to currently enrolled medical or nursing students; there is little availability or opportunity for individuals who are not being trained in those professions to begin with.
There is therefore an opportunity to structure clinical research through education, training and certification. The creation of basic Canadian educational standards and qualifications and being able to offer training to healthcare professionals stands to benefit the field of clinical research. This is not to suggest that formal training should overnight become a requirement for those involved in clinical research but rather that clinical research would benefit from being more formally structured.
In addition, such training might increase the utilization of otherwise wasted yet readily available knowledge and skills held, for instance by foreign medical and dental graduates, internationally trained nurses, physiotherapists and other internationally trained healthcare workers and health related scientists.
Recent years have seen continued growth in demand worldwide for both capacity and productivity in clinical research. Spending on Research and Development by the biopharmaceutical industry, estimated at US$33 billion worldwide in 2001, has been growing by 15% per year, so that this figure currently stands at about US$66 billion. Approximately 40% of this R&D is accounted for by Clinical Trials, a principal activity of clinical research, and Canada is a major participant in this worldwide activity.
The field of clinical research is a unique, health-related activity because it draws on a variety of different healthcare professionals and individuals with health-related training, which come together to contribute different areas of knowledge and skills to a common objective. All these people work together in the exciting field of clinical research.
Nicholas Herten-Greaven is a retired medical doctor (Royal London Hospital, England) and head of the Clinical Research Program at Oxford College of Arts, Business and Technology.
