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Journal of Postgraduate Medicine, Vol. 55, No. 2, April-June, 2009, pp. 150 Letter Need to regulate burgeoning clinical research courses Bhan A Independent Researcher, Bioethics and Public Health, Pune Code Number: jp09041 Related article: jp08107 PMID: 19550067 Sir, The article by Thatte and Bavdekar [1] provides a comprehensive landscape view of the emerging field of clinical research in India. One of the areas for improvements identified in the paper is capacity building, especially among investigators and other staff members who are associated with conducting clinical trials. Realizing the need for more trained professionals in clinical research as being a business opportunity, many institutes offering clinical research courses have sprung up in the last few years in the country. Promising a career in clinical research as being the next wave after Information Technology (IT) and Biotechnology (BT), and using ambitious projections about the possibilities of employment in the growing number of Clinical Research Organizations (CROs) all over the country, these institutes are drawing a lot of students who are ready to pay a hefty course fee. However, the mushrooming of clinical research courses without accreditation and quality control mechanisms in the country should be a cause for concern. Many institutes have been set up autonomously, some with links to foreign universities. Only a few are based and associated with recognized Indian universities. A 2008 newspaper article listed the number of institutes offering clinical research courses as fifteen; two institutes had foreign university affiliation, and three were affiliated to Indian universities; two institutes offered masters level courses, and fourteen offered diploma/certificate courses. [2] These numbers are probably an under-estimate. During online research, I could not find comprehensive information on how many students graduated annually from all these courses, and the percentage of graduates getting employed in clinical research jobs. The author of the newspaper article, [2] the president of clinical research services at one of the institutes, wrote in the article that the first batch of students at his institute comprised of 48 students, and half of them had got jobs at the time of writing the article (while the rest were in the selection process). The structure of courses being offered varies from certificate courses to post graduate diplomas to masters′ level courses. This makes it difficult to attempt to exercise oversight over the content of the courses, the fees charged, and the way the courses are run. This lacuna needs to be addressed by regulatory bodies in the field of education like University Grants Commission (UGC) and the All India Council for Technical Education (AICTE). This will ensure that a tab is kept on the institutes, including monitoring on a regular basis. A core curriculum with mandatory components can be evolved which will ensure that all students undergoing courses will have at least similar basic knowledge in the field. This would for example include course components on foundations of research, Good Clinical Practice, use of statistics and software in research, research ethics and regulatory affairs, trial management and internships at clinical trial sites or CROs etc. Accountability systems for institutions offering clinical research courses would be important to ensure that students are offered what has been promised on admission, and also so that institutes do not suddenly abandon students mid-way in the course. Clinical trials involve research on patients or volunteers. The principle of ′professional competence′ is one of the twelve general principles enunciated in the Indian Council for Medical Research Ethical guidelines for biomedical research on human participants. [3] To ensure that the risk for trial participants is minimized and conduct of research optimized, it is imperative that studies should be designed, carried out, analyzed, and reported by well-trained professionals. Regulating clinical research courses is an important step in this direction. References
Copyright 2009 - Journal of Postgraduate Medicine |
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