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Clinical Research Training Strategies


You are finishing up your postgraduate studies or postdoc and are thinking about pursuing a career in clinical research (CR). You?ve heard that there is an abundance of jobs for folks who manage clinical trials. The reality, unfortunately, is that the transition from the bench to a clinical research setting--usually as an entry-level clinical research associate (CRA) or project coordinator--is often neither straightforward nor easy.

So, how do you transfer your basic science skills to the clinical research setting? CR neophytes take heart--some Canadian academic institutions are recognizing the need for programmes emphasizing clinical research training and coursework for scientists. Budding trainees can pick and choose from graduate programmes, diplomas and certificates, and postdoctoral fellowships. With a little forward planning, other steps--such as volunteering and joining professional associations--can prepare a job seeker with the crucial experience that is now necessary for that all-important first job.

Back in the Good Old Days

There was a time when a science graduate could find work as a CRA quite easily. Kim McDonald-Taylor is vice president of operations at Endpoint Research Ltd., a contract research organization (CRO) that services pharmaceutical and biotechnology companies. She says that when she entered the industry in 1988 with a master?s degree, the situation was quite different from today?s. "I actually responded to an ad in the local newspaper for a CRA, interviewed, and was hired. At the time, I had 10 years experience as a research associate doing both toxicological and wildlife research at the University of Guelph and Ontario Veterinary College," she says.

However, the pharmaceutical industry has evolved significantly since then, and many companies have been downsizing. McDonald-Taylor says that someone with a similar set of skills would have trouble entering the industry now, because companies cannot take the time to train individuals. The result, says Jackie Gladman, marketing director of Innovus, another CRO, is "a hole in the training of graduates." Contract research companies such as Innovus are scrambling for the same small pool of appropriately qualified and experienced individuals.

Want Experience? Volunteer!

Although there is an abundance of highly educated and skilled young scientists in Canada, many applicants vying for non-laboratory-based jobs in clinical research have been trained in a highly focused, technical area of science. In the prospective employer?s view, these people lack flexibility in outlook and the management skills required to take a project from the gene to the in vitro stage. Gladman, who attends a lot of job fairs, says that the most common mistake made by M.Sc. and Ph.D. graduates is applying for positions such as project manager that they are not qualified to fill. She points out that most academically trained basic scientists have little or no knowledge of the pharmaceutical industry, how clinical trials are prepared and conducted, how ethics approval is obtained, how the data are analyzed and interpreted, or how new drugs are approved.

Gladman recommends that job seekers try to gain crucial "real world" experience through volunteering. Find an investigator in an academic institution or hospital research institute conducting clinical trials and express an interest in becoming involved in a trial for several months to a year. "It?s a good way to become familiar with the terminology and processes associated with clinical trials," says Gladman, as well as an opportunity to prove your mettle to potential employers.

Graduate Training in Clinical Research

If you are really serious, there are a number of graduate programmes in Canada that can help orient students to a wider clinical career spectrum. At McMaster University, for example, the Department of Clinical Epidemiology and Biostatistics provides master's and doctoral training through its Graduate Programme in Clinical Health Sciences (Health Research Methodology). McMaster?s programme, which has been running since 1972 at the master?s level and since 1997 at the Ph.D. level, is widely viewed as a pioneer in the discipline of clinical epidemiology in Canada. The programme allows students to concentrate their studies in clinical epidemiology, biostatistics and clinical trials, health economics, health policy, or public health. Christel Woodward, coordinator of the programme, tells Next Wave Canada that its graduates have excellent track records of finding work in industry, universities, and research institutes.

The University of Western Ontario also offers full-time and part-time Ph.D. and M.Sc. programmes in epidemiology and biostatistics. Students in the Ph.D. programme have the choice of specializing in one of two streams: population epidemiology or biostatistics. Students in the M.Sc. programme specialize in one of three streams: population epidemiology, clinical epidemiology, or biostatistics.

The Clinical Sciences Program at the University of Sherbrooke offers 2-year M.Sc. or 3-year Ph.D. multidisciplinary degrees in clinical science. The program claims to provide rigorous training in research methodology, as well as in theoretical concepts that underlie the specific fields of application. Research areas of interest are various and include rehabilitation; mental health; ethical issues in medical intervention; infectious, chronic, and congenital diseases; physiopathology of various systems; environmental health; functional autonomy of the elderly; and others.

Postdoctoral Training Opportunities

You can also pick up training as a postdoc. For example, Wyeth-Ayerst Canada Inc., the Canadian Institutes of Health Research (CIHR), and the Research-Based Pharmaceutical Companies (Rx&D) industry association have teamed up to provide funding for postdoctoral positions for up to 2 years in several therapeutic areas of interest to Wyeth-Ayerst. (Details of CIHR's research areas and the programme can be found on the CIHR Web site.) The awards are available to Canadian citizens and permanent residents who hold either a Ph.D. (within 5 years after completion) or M.D. degree (or equivalent) and any foreign graduate candidate (M.D. or Ph.D.) who is registered for postgraduate training in Canada. [CIHR is a sponsor of Next Wave Canada.]

Diplomas and Certificates in Clinical Research

While universities offer a useful mechanism for addressing some clinical research workforce training needs through graduate programmes, many individuals simply do not have the time to go back to school to take conventional full-time, graduate courses. Employees already working in the industry or recent M.Sc. and Ph.D. graduates looking for extra training in clinical research may want to consider the option of a postdegree diploma program at a university or vocational school.

The Graduate Diploma in Clinical Research at McGill University is a 1-year full-time or 18-month part-time program. It is designed to provide both academic and industry-driven clinical research with employees that have fundamental training in clinical research, through coursework and hands-on training in the execution of a clinical trial.

The Humber College in Toronto offers a postgraduate certificate in clinical research. The program is popular with CROs, as it is seen to provide a good pool of experienced graduates. The certificate provides students with the specialized knowledge and skills required to design, monitor, and manage clinical trials, and industry professionals provide the training. As well as the academic study component, the program provides practical experience and networking opportunities through an intensive 12-week industry internship.

The British Columbia Institute of Technology in Burnaby runs an Advanced Specialty Certificate for postdegree health care professionals. This online program provides theoretical background in the areas of medical product regulations, project management, business development, research methodology, marketing, communication, and study conduct. In addition, the recruitment company Kelly Scientific Resources® and the Pharmaceutical Education and Research Institute each offer distance education courses in clinical monitoring and the essential good clinical practices (GCP).

While courses offered through distance learning are a convenient alternative to conventional academic programs, they naturally suffer from the lack of hands-on experience in the execution of clinical trails and from the difficulty in teaching team-building skills in an online environment. But these courses can provide job seekers with a definite advantage when combined with a science background and some entry-level experience in managing clinical trials (as a project coordinator, for example). Chris Jock, senior director of the Kelly Science & Healthcare Services Group, says that pharmaceutical and biotech companies value scientists trained in health and biological and physical sciences--when that training is complemented with clinical research training--due to their understanding of the science behind the drugs as well as the applications.

Network, Network, Network

But, as is usually the case, the best approach for postdocs and grad students keen on a career in clinical research is to network as much as possible. A good way to do that is to join professional associations, such as the Clinical Research Association of Canada (CRAC) , or the Association of Clinical Research Professionals. Attend meetings and courses endorsed by these associations. McDonald-Taylor acts as president of the CRAC: "The work we do with CRAC is more augmentation of knowledge. It is usually quite practical and focused for clinical research." She says that it is certainly worthwhile for postdocs and grad students to attend, "even if only for networking possibilities with pharma and biotechnology companies."