It was a drug used initially for treating urinary tract infection and other ailments. Doctors in India treating tuberculosis (TB), however, discovered that Cyprofloxacin, when used with other anti-TB drugs, effectively cured the disease in shorter period of time.
An Australian doctor who went on to win the Nobel Prize found that acidity was not the sole cause of peptic ulcer. The real culprit was a microorganism called Helico Bacter Pylori. If patients were treated just for acidity they got temporary relief but the ulcer would recur. Killing the bug brought about a complete cure. The medical fraternity of the world was convinced of the bug-theory after innumerable clinical trials and articles published in leading medical journals.
Welcome to the world of clinical research, which is a branch of medical science that determines the safety and efficacy of medications, devices, diagnostic products and treatment regimes intended for use on human beings. These can be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
“Clinical research means research work done in clinical science that includes all the (clinical) subjects of medical sciences together with drug research, material research, device or equipment research, genetic research, research related to diagnosis, treatment management, and public health issues,” says Dr S Y Kothari, additional director general health services and head of physical medicine and rehabilitation department, Safdarjung Hospital and Vardhaman Mahavir Medical College, New Delhi.
“The aim of clinical research is to improve healthcare in the society by making safe and effective drugs available at low costs,” says Shiv Raman Dugal, chairman, Institute of Clinical Research India (ICRI), a private sector institute imparting education on clinical research.
“When a product is developed it is first tried on animals, then on human volunteers and then released for consumption by the general population, leading to finality of a finished and government-approved product,” says Dr Kothari.
Who can become a clinical researcher? “Doctors – with specialistion say in cardiology, gastroenterology etc – who are trained in good clinical practice (GCP) can become clinical researchers,” says Dr Dhananjay Bakhle, executive vice president, medical research, Lupin Ltd. Cinical research is not taught in medical colleges. Doctors have to acquire the required knowledge and then become clinical researchers. “No certification is mandatory, to become a clinical researcher,” he says.
Dr Kothari, however has a different take. “Even an MBBS doctor can do clinical research. What is important is an objective and unbiased mindset,” he says.
But all researchers need not be doctors. Even a science (life sciences) graduate or a paramedic can work as a clinical researcher in the pharma industry or in a clinical research organisation that generally monitors and analyses the results of a trial.
“The clinical research market worldwide is worth over $52 billion, with 70 per cent of the business generated within the US,” says Dugal. Activities are picking up in India too. “Registered clinical trials in India have gone up from 221 in 2007 to around 1300 in 2009,” he adds. And the market is growing, thereby creating job opportunities. “Currently, 2.50 lakh positions in clinical research are said to be available worldwide with 50,000 job openings in India within the next three to five years,” he says. Little wonder then that Sanjay Gupta, an expert in the field, calls it a ‘sunrise industry’.
What's it about?
Clinical research is part of medical science devoted to the study of effects of medicines on patients. The purpose of the study is to bring new medicines in the market. The clinical trials that are done for the purpose are under direct monitoring of the pharma companies. However, 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 pharma companies might not be monitoring their work.
9 am: Reach workplace. Plan for the clinical trial projects that are underway or will take place shortly
10.30 am: Work related to project management. Schedule for the trials is prepared.
11.30 am: Data collection work begins at the hospital
12 noon: Interact with the team led by the investigator in the hospital
1.30 pm: Data collection work 4.30 pm: Prepare travel plans
5 pm: Prepare detailed report on the clinical trials that have taken place in the day at the hospital.
6 pm: Interact with the superiors/bosses
7 pm: 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.
Entry level: Rs3,00,000 to Rs4,00,000 per annum
Middle level: Rs7,00,000 per annum
Senior level: Rs15,00,000 per annum
Clinical researchers in government set up earn less than this
. Integrity. It is a must because scientific experiments are conducted on humans
. Basic management skills. This is more applicable to the clinical researchers working in the industry as they have to monitor the trials that are taking place
. Good analytical skills; as a great amount of data collected through clinical trials needs to be interpreted.
. Eye for detail and accuracy
. Leadership qualities
. Good communication skills
How do i get there?
. Take physics, chemistry, biology at the plus-two level. You will have to then write the entrance examinations for admission to a medical college. Do your
MBBS. Specialise in a field after that. Acquire training in good clinical practice (GCP). Become a clinical researcher.
. You need not be a medical practitioner if you work in the industry side. A degree in paramedical sciences or life sciences will make you eligible.
However you need to train yourself on GCP
Pros & Cons
It’s a noble profession as you develop new medicines that could cure millions
The challenge involved is worth doing the job
Salaries are high, especially at the middle and senior level
It is not as glamorous as it is projected to be. It involves real hard work
You will have to travel a lot
India needs more researchers
An industry expert on the opportunities in this profession
What is the scope of work of a clinical researcher in the country?
There’s immense scope within the pharmaceutical industry and within the hospital set-up. People in hospitals, primarily doctors, conduct clinical research on patients. Then there are clinical researchers in the pharma industry or the clinical research organisations that supervise/ monitor the research (conducted in hospitals).
Are there adequate numbers of good clinical researchers in the country?
Yes, there are when it comes to monitors from the pharma industry and the CROs (contract research organisations), but we do not have many researchers in the hospitals actually conducting trials. India has between 500 and 750 good investigators — doctors who conduct clinical trials in hospitals. This number has to dramatically increase if good clinical trials have to happen here.
Where can a clinical researcher find employment?
Apart from the hospitals and medical research organisations, clinical researchers can work for pharmaceutical companies and CROs.
What are the challenges before the profession today?
One of the biggest challenges is to change the public perception of clinical research. In a country like India, unfortunately, the public perception of clinical research is negative, simply because India hasn’t introduced new drugs and, therefore, the Indian population has not realised that for bringing new drugs into the market you have to go through the process of clinical trials. For them, this is something that happens in developed countries. Clinical trials here are looked at, even today, with suspicion. A few isolated instances of clinical trials going wrong might have led to the mindset.
The second challenge is that there is a growing international competition in clinical research. As India is getting ready to conduct global clinical trials other countries are feeling the pressure as they think that if India goes ahead in clinical research, then the thousands of jobs that are created in their countries will start moving to India.
Dr Dhananjay Bakhle Interviewed by Pranab Ghosh