ALL YOU NEED TO KNOW ABOUT A COURSE OF YOUR CHOICE:-

Clinical research deals with the testing of new pharmaceutical drugs, biological, herbal and natural remedies, certain food products, and select cosmetics for drug safety and efficacy before they are introduced in the market. Basically, clinical researchers are the ones who ensure that our favourite painkiller or everyday moisturiser is not slow poisoning us.

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CHECKPOINT: Clinical researchers conduct tests on pharmaceuticals and drugs for safety and efficacy before they are introduced in the market

The testing for drugs on humans comprises a series of clinical trials before the product is launched and another round after it is launched. The data collected from these trials has to be submitted to the appropriate health authorities such as the drugs controller general to seek approval before the product is ready to be sold.

Before a pharmaceutical company can initiate testing on humans, it must conduct extensive pre-clinical or laboratory research. This research typically involves years of experiments on animal and human cells. If this stage of testing is successful, a pharmaceutical company provides this data to regulatory bodies, requesting approval to begin testing the drug on humans.

Thus, clinical research is the study of drugs or devices in human subjects with the intent to discover potential beneficial effects and / or determine its safety and efficacy. It is also called clinical study or clinical investigation.

Clinical research relies on trials that vary greatly in terms of the number of researchers involved. A trial could be anything from the findings of a single researcher in one hospital or clinic to those of an international study involving several hundred participating researchers hailing from various continents. The number of patients tested can range from as few as 30 to several thousands. Clinical research professionals conduct studies in the areas of oncology, neuropsychiatry, vaccine development, endocrinology and osteo-arthritis.

What do I have to do?

In a clinical trial, the investigator begins by identifying the medication or device to be tested, decides what to compare it with (one or more existing treatments or a placebo), and then zeroes in on what kind of patients might benefit from the medication / device. If the investigator cannot find enough patients with the specific disease or condition, he assembles investigators at other locations to look for patients who may receive the treatment.

During the clinical trial, investigators select patients with the predetermined characteristics, administer treatment and collect data on the patients’ health for a defined time period. Among other factors, researchers look at whether the patients’ health improves or not. The data is then analysed using a battery of statistical tests.

Especially when the trial involves the comparison of two or more types of treatment spread out over different locations, researchers in each location are meant to carry out the trial in the same way on patients with the same characteristics.

India has one of the largest patient populations for most diseases with genetic diversity. Availability of highly qualified medical practitioners is attracting global clinical trials in hospitals and clinical sites since India has implemented good clinical practice (GCP) as per ICH global standards. It is now possible that the data from trials in India as per GCP guidelines may be submitted for approval of the drug in the US, Europe and Japan among others.

What should I study?

You should have a BSc degree to enter this field. You could specialise in pharmacy, medicine, life science and bioscience. Within bioscience, there are various other fields such as botany, zoology, biochemistry and genetics. Good communication skills and a thorough knowledge of the subject are essential.

What next?

India is becoming a hub for clinical research and the demand for professionals in this field is growing rapidly. Clinical research business is doubling in revenue every two years and is estimated to be worth $1 billion by 2010. Thus, there will soon be a massive demand for clinical research professionals, making it an interesting career option. According to a report, there are more than 50,000 jobs in clinical research in India. With the influx of multinationals setting up research facilities here, the industry is poised to grow exponentially.

Career prospects include a professional career in the clinical research industry either as a clinical investigator or site co-ordinator in a hospital / CR organisation. Jobs in the pharmaceutical industry, drug development, medical writing, biostatistics are also available, as well as the option of managing clinical projects or trials.

You can have rewarding and challenging assignments and career opportunities in the areas of information technology, biometrics, medical affairs, quality assurance, clinical trial diagnostics, and pharmaco-vigilance. Indian companies like Ranbaxy Laboratories, Wellquest (of Nicholas Piramal group), Biocon and Matrix Laboratories conduct clinical trials, and so do organisations like Reliance Clinical Research Services and Veeda Clinical Research.

For multinationals, conducting clinical trials in India is cost-effective. There are also pure CROs, which mostly provide outsourced services for data management.

The most common entry-level position is that of a clinical research associate (CRA). This is followed by the post of biostatistician and then clinical research manager. There are other posts too such as clinical research co-ordinator, business development manager, clinical research investigator and clinical data manager.

Where to study:-
Academy for Clinical Excellence (ACE), Bombay College of Pharmacy, Mumbai.
Institute of Clinical Research (ICRI), New Delhi (with campuses in Mumbai, Bangalore & Ahmedabad).
Bioinformatics Centre, University of Pune, Pune.
St Xavier’s College, Mumbai.
Lotus Clinical Research Academy, Koramangala, Bangalore.

Sources: The Telegraph (Kolkata, India