One may think, why invent a new drug when there is an array of drugs in the market already? Well, in the era of inventions and progression there is always a possibility of better ones for a better life and that is why we have clinical research. Clinical research is a medical study or an investigation that involves individuals like us. It is a science that controls the safety of medications, devices, diagnostic products and treatment procedures meant for human use. People volunteer to take part in carefully conducted investigations or studies that eventually discover improved or healthier methods and approaches to treat, prevent, diagnose, and understand human disease. Clinical research also known as Clinical trials dawns in a laboratory. Clinical trials help in providing valuable information in advancement of a disease and health.
Why India for Clinical Trials?
India has been the much-preferred destination for clinical trials, mainly due to the constructive development of trials in the last few years. Today India accounts for 20% of the world’s disease burden and 17% of the world’s population, hence the scope for clinical trial in India is enormous considering the contagious and non-contagious disease. Doctors conducting the trials in India are regularly inspected to ensure there is adequate care given to the patients as well as quality associated with the data during preparation. The pharma companies have shown more interest in developing drugs for diseases that commonly arises in India.
Clinical research industry in India have seen a significant boom since the revision of global standards in 2015, which has led to more opportunities for India. The industry in India has seen some recent developments like approvals for clinical trials now take about six to seven months, which used to be 15 months couple of years back. The industry has also brought in changes with regard to compensation, like in an event of an adverse drug reaction the patient is compensated only up to the point that the drug did the damage.Also, the regulators have now indicated that audio visual recording of informed consent is not mandated for all clinical trials, though a little more clarity is awaited on this.
The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority in India. The Drugs Controller General of India (DCGI) is an official of the CDSCO, a final regulatory authority for the approval of clinical trials in India who conducts inspections of the sponsors and clinical researchers. The knowledge of the regulatory requirements is an essential imperative for investigators.
Career Opportunities in India
India makes a count of 6,500 employees out of the 36,000 globally, of which 1,000 employees are in IT services and the rest are supporting business functions in clinical trials. Many of the top pharma companies today in look out for hiring passionate professionals. Companies like Pfizer, Cipla, Sun Pharmaceutical, Biocon, GlaxoSmithKline Pharmaceuticals etc are in constant hunt for clinical research professionals. These companies hire experienced and passionate professionals for a myriad of roles.
A Clinical Research Associate(CRA) is one such a role who handles activities mainly concerning clinical trials. The role requires not only to manage the trials but also in supervising the quality and the closure of the studies as well.
A Clinical Research Coordinator (CRC) is another specialized role who works under the principal Investigator. The CRC supports, coordinates and facilitates clinical trials and plays a crucial role in its studies as well as the overall administration in aspects to clinical studies at a research centre level.
There are many institutions around offering courses in the field of clinical research. The James Lind Institute is a devoted institute which hosts a wide range of professional courses in various fields for one to excel in the clinical research industry. The Post-Graduate Diploma in Clinical Research (PGDCR) is one such course that offers broad understanding and the relevant knowledge in various areas of clinical research expected to have for a clinical research associate.
To know more about the clinical research courses you may visit the following link: Online Clinical Research Course