Thursday, July 19, 2012

How to Start a Career in Clinical Research

It has been only a couple of decades since clinical trials are being conducted in India. It was in early 1990?s that large multinational pharmaceutical companies started conducting human trials through their offices in India. Multinational companies made use of their extensive clinical study experience gained in the west to successfully execute trials in India while following all international guidelines and regulations. Although it was a success but a lot of challenges were faced by these companies at that time to achieve measurable results and to comply with the regulations that govern clinical trials. One of the major challenges was the unawareness and lack of training of clinical investigators and their staff. Not many doctors were comfortable with the idea of making their patients a part of a clinical trial, nor did they have a good understanding of the drug development process. It was only a handful of doctors who had good patient flow and good reputation experience in the west that did participate in Indian clinical trials. Soon, companies started to realize the immense potential India had as a region were new drugs could be developed faster and cheaper. This led to more and more drug companies initiating trials in the country with an increased number of trained physicians alongside. Although the challenges were many when clinical trials were started in the country most of them were collectively overcome by the industry. With the growth of the industry many new challenges such as those posed by the changing Indian regulatory environment have come up and some old ones such as the need for formal clinical research training continue to exist.

The need for clinical research training of all staff members who participate in clinical trials such as study coordinators, principal investigators, clinical research associates, data managers, project managers etc has been reiterated by all regulatory bodies and guidelines. As per the International Conference on Harmonization Good Clinical Practice (ICH-GCP) guideline, it is mandatory for all staff members to be adequately trained on the study conduct. They must know the guidelines and regulations applicable to them that must be followed and should also be aware of their study specific documents such as the study protocol.

To achieve this clinical research training it is always recommended to enroll in a clinical training program at a reputed institute. Not that you have to spend all your time attending classes. You can easily enroll in an online clinical research program such as that offered by the James Lind Institute and reach the required competence level expected of a research professional. A quality online training program is enough for you to get started and to work in the research industry.

The author of this article is a student at James Lind Institute. With an experience of more than 5 years, she is well-versed with the problems students face in the field of clinical research training

Clinical research is a division of medical science that insure the safety and effectiveness of medicines, equipment, diagnostic products and therapy regimens intended for people use. These may be used for protection, treatment, medical diagnosis or for reducing symptoms of a disease. Clinical Research is unique than clinical practice.

Source: http://toddsblogs.com/referenceandeducation/2012/07/18/how-to-start-a-career-in-clinical-research/

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