Before a new drug gets approved in the market by a regulatory authority and is prescribed as “safe and effective when used as directed” it undergoes a series of trials in human beings (of course, before being tested in animals first) which we now know of as Clinical Trials. The whole process takes years and pharmaceutical companies all over the world spend billions of money to fund clinical trials. This perhaps leads us to wonder about who covers the whole process of trials and what expertise one may require to make sure that results are effective and comprehensive, not to mention the fact that the safety and well being of the subjects involved in the trial must be always safeguarded by all means.
It is very important for every individual participating in the trial to make sure that the trial is a success. But there lie a number of obstacles in the path of good research. The first and foremost being the lack of the professional clinical researchers who understand the need in depth and are always updated with the various regulatory changes which keep happening at regular time interval to safeguard the right of the subjects involved in the trial.
It is a multi disciplinary field and requires the expertise of various professionals like Physicians and Consultants, Nurses, graduates from Life Sciences background etc. With the DCGI in India becoming very strict with the various Ethics Committees across the country, it is mandatory for each of the members of an Independent or Institutional Ethics Committee as well to be up to date with norms of clinical research.
This is where the importance of a good clinical research training institute comes in. Most of the physicians may have their primary training only in the field of medicine. So will be the case with other professionals as well. Various members of Ethics Committee are from very different backgrounds such as Lawyers, Home Makers, and Professor etc. There is a need for institutes which offer multi disciplinary courses in clinical research and develop a program in order to nurture all of the professionals mentioned above who may get involved in clinical trials in the future.
At the James Lind Institute , various courses are being taught online targeting professionals and fresher alike from all spheres who are looking forward to get into this exciting field or are looking forward to enhance their knowledge for career progression in this sector.