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Vital testers

Clinical research is a multidisciplinary science devoted to the study of the effects of medicines on patients. The purpose of the study is to bring new medicines into the market after thoroughly researching their desirable and undesirable effects.

education Updated: Jul 24, 2012 16:32 IST

The lowdown
Clinical research is a multidisciplinary science devoted to the study of the effects of medicines on patients. The purpose of the study is to bring new medicines into the market after thoroughly researching their desirable and undesirable effects. Every drug which comes into the market goes through a series of tests on animals and humans. Monitoring of drug action after marketing, too, is desirable and sometimes approved drugs are withdrawn when a serious adverse reaction is reported because of administration of those drugs. Clinical trials done for the purpose — provided the results are positive — are under direct monitoring of the pharmaceutical companies.

The Drug Controller General of India approves the drugs after strict compliance. There is another group of clinical researchers who primarily work in hospitals. They are the doctors, clinicians basically, who create formulas to treat patients. They work on new treatment patterns for existing diseases, but pharmaceutical companies might not be monitoring their work. It is also essential that each clinical trial is approved by an ethics committee which includes, besides experts, laymen

Clockwork
The average work day of a clinical researcher depends on the organisation (such as a university, an R&D institution, a hospital or a pharmaceutical company) he/she is employed in. A day in the life of a clinical researcher in a hospital is as follows:
9am: Reach workplace. Plan for the clinical trial projects that are underway or will take place shortly
10.30am: Work related to project management. Schedule for the trials is prepared
11.30am: Data collection work begins at the hospital
Noon: Interact with the team led by the investigator in the hospital
1.30pm: Data collection work
4.30pm: Prepare travel plans (if needed under project).
5pm: Prepare detailed report on the clinical trials that have taken place in the day at the hospital
6pm: Interact with the superiors/bosses
7pm: Call it a day, if I am lucky

The investigators - the doctors who conduct clinical trials - have a different schedule. All of their time is spent with the patients on whom the trials are done in the hospital

The payoff
Entry level: Rs. 300,000 to Rs. 400,000 per year. Clinical researchers in a government set-up earn less than this amount

Skills/TRAITS
* Integrity is a must because scientific experiments are conducted on humans
* Basic management skills. This is more applicable to clinical researchers working in the industry as they have to monitor trials
* Good analytical skills as a great amount of data collected through clinical trials needs to be interpreted
* An eye for detail and accuracy
* Leadership qualities
* Good communication skills
* Observational skills
* Knowledge of statistics

Getting there
Read physics, chemistry and biology in Class 11 and 12. Knowledge of biology is a must. At the bachelor’s level, go for a degree in medicine, paramedical sciences, life sciences or biotechnology. Then go for an MSc in clinical research or MPharm in pharmacology, pharmacy practice or MSc in toxicology. A PhD is recommended for better career prospects. “You should preferably have a BSc in biological science. You need not be a medical doctor if you wish to work in the industry. However, you need to train yourself on good clinical practice (GCP),” says S Raisuddin, professor, department of clinical research, Jamia Hamdard, New Delhi. So, acquire training in GCP to become a clinical researcher.

Institutes and URLs
* National Institute of Pharmaceutical Education and Research, Mohali, Chandigarh
www.niper.ac.in
* Institute of Clinical Research (India)
www.icriindia.com
* BCare Clinical Research Centre, Pune
* Bombay College of Pharmacy
www.bcpindia.org
* Delhi Institute of Pharmaceutical Science and Research
http://dipsar.in
* Jamia Hamdard (Hamdard University), New Delhi
www.jamiahamdard.edu

Pros and cons
* It’s a noble profession as you develop and test new medicines that could cure millions
* The challenge involved is worth doing the job
* Salaries are high, especially at the middle and senior levels
* The profession is not as glamorous as it is projected to be. It involves real hard work and a high level of commitment

Join clinical research career with more than 100% commitment to human welfare and well-being S Raisuddin, professor, department of clinical research, Jamia Hamdard, New Delhi