subject: Career Benefit - Clinical Research Training [print this page] Its been couple of years since clinical studies are being conducted in India. It was in early nineties that huge multinational pharmaceutical drug organizations started conducting clinical studies by their offices in India. International organizations made use of their in depth clinical trial expertise gained in the west to successfully execute clinical trials in India even though following all international guidelines and regulations. Despite the fact that it was a success but a lot of challenges were faced by these organizations at that time to achieve considerable outcomes and to abide with the regulations that govern clinical trials. One of the major issues was the unawareness and lack of training of clinical researchers and their team. Not many health professionals were comfortable with the idea of making their patients a part of a clinical trial, nor did they have a good familiarity with the medicine development process. It was only a handful of medical professionals who had good patient flow, excellent track record, and clinical trial practical experience in the west that did get involved in Indian clinical trials. Soon, companies started to realize the tremendous possibilities India had as a region were new drugs could be formulated faster and inexpensive. This led to more and more drug organizations commencing clinical trials in the country with an higher number of qualified doctors beside. Despite the fact that the issues were many when clinical trials were commenced in the country most of them were together overcome by the industry. With the expansion of the market many new challenges such as those presented by the changing Indian regulatory ecosystem have come up and some old ones such as the need for formal clinical research training continue to exist.
The need for clinical research education of all personnel who engage in clinical research such as research coordinators, (PI)principal investigators, CRA (clinical research associates), (PM)clinical project managers etc. has been reiterated by all regulatory bodies and recommendations. As per the International Conference on Harmonization Good Clinical Practice (ICH-GCP) guideline, it is necessary for all personnel members to be properly educated on the Clinical Research conduct. They must know the guidelines and legislation applicable to them that must be implemented and should also be aware of their study specific documents such as the study protocol.
To obtain this Clinical Research Training it is usually suggested to join in a clinical research education program at a well-known clinical research institution. Not that you have to invest all your time participating in classes. You can simply enroll in an on line clinical research program such as that offered by the James Lind Institute and reach the required expertise level expected of a clinical research expert. A quality on line educational program is sufficient for you to get began and to work in the clinical research field.
