Careers with Dr Vibha

Clinical study. Clinical trial. Clinical protocol. They all mean the same thing - a scientific study of how a new medicine or treatment works in people. Through clinical studies, doctors find new and better ways to prevent, detect, diagnose, control and treat illnesses.

CLINICAL RESEARCH

THE WORK
Clinical research involves investigations that determine the safety and effectiveness of drugs, devices, diagnostic products, vaccines and treatment regimens intended for human beings. Many new pharmaceutical drugs, biological, herbal and natural remedies, some food products and cosmetics are found to be helpful. But all these require drug safety and efficacy testing or trials before they are introduced in the market.
Clinical trials are usually conducted in four phases. Initial testing called Phase-I is carried out on healthy and informed volunteers to understand the safety profile and observe how the body handles the drug (i.e. pharmacokinetics). Subsequent phases II and III are carried out on patients suffering from the disease to understand the efficacy (whether it really works) and safety of the medication. Phase IV trials are conducted by the company after its limited commercial launch to monitor how thousands of patients, prescribed the drug by their doctor, react to the medicine and study any unforeseen situations that might occur.
After completion of all the phases, the regulatory agency reviews the data obtained from thousands of patients. If the medication proves to be effective without causing many side effects, permission is granted to market the product. However the pharmaceutical manufacturer (sponsor) is expected to monitor any new risks/side effects even after the drug is marketed. In general, a clinical research associate (CRA) sets up, monitors and completes clinical trials, but the work may vary tremendously. In some companies, they may be involved in the whole process: sitting down with the doctor who has the idea for a trial, working out a protocol, and writing up reports after the analysis has been done. In others, a medical adviser would initiate the trial - the researcher would then monitor clinical trials and collect data.

GETTING IN
This area of work is open to graduates with a degree in life and medical sciences. Studying further helps one in bettering their current job profile. One can opt for a full-time two-year M.Sc. in Clinical Research, offered by many prominent universities after graduation. Further knowledge can be achieved through diploma and certificate courses such as advanced courses in pharmacovigilance (safety) or in clinical data management and statistics. For those interested in serious research work, a Ph.D. is the ideal solution.
PG courses usually cover the entire gamut of drug development from pre-clinical to post-marketing activity, clinical research and data management; good clinical practice, trial design, and life cycle of a trial, the regulations involved, standard operating procedures; ethical and quality issues; personal development; and IT skills and an understanding of the various services offered under clinical trials.
Various colleges all over India offer post-graduate degrees and diplomas. Typically, the selection procedure for most courses is a qualifying written examination followed by a personal interview to gauge level of interest and aptitude.

KEY SKILLS